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Purpose: To evaluate two pharmacologic antibiotic prophylaxis regimens and a control group of immunocompetent patients undergoing two-stage dental implant placement in a triple-blind randomized controlled clinical trial. Materials and Methods: From a group of 61 immunocompetent patients, 21 were randomly allocated into group 1 (G1) without antibiotic prophylaxis (control), 20 in group 2 (G2) with preoperative antibiotic prophylaxis (1 g amoxicillin 1 hour before the procedure), and 20 in group 3 (G3) with preoperative (1 g amoxicillin) and postoperative (500 mg every 8 hours for 5 days) antibiotic prophylaxis. Pain was assessed with the visual analog scale (VAS) and by considering the number of painkillers patients used. Infection was identified via the presence of pus and fistula. Patients were evaluated after 7, 14, 30, and 120 days. Implant failure (defined as mobility upon the application of manual torque) was evaluated after 120 days during the second surgical stage. Results: At the 7-day follow-up, pain intensity was less severe in the patients who had received antibiotics, with the G3 patients experiencing the least pain (P < .05). Infection was present in groups G1 (2 cases) and G3 (2 cases), but there was no statistically significant intergroup difference. Two implants failed, one in G1 and the other in G3. Conclusions: Based on the results of the present study, although the use of antibiotics reduced pain in the immediate postoperative period, it did not reduce infection rates and implant failure in immunocompetent patients. [ABSTRACT FROM AUTHOR]

Background Native joint septic arthritis (NJSA) is definitively diagnosed by a positive Gram stain or culture, along with supportive clinical findings. Preoperative antibiotics are known to alter synovial fluid cell count, Gram stain, and culture results and are typically postponed until after arthrocentesis to optimize diagnostic accuracy. However, data on the impact of preoperative antibiotics on operative culture yield for NJSA diagnosis are limited. Methods We retrospectively reviewed adult cases of NJSA who underwent surgery at Mayo Clinic facilities from 2012 to 2021 to analyze the effect of preoperative antibiotics on operative culture yield through a paired analysis of preoperative culture (POC) and operative culture (OC) results using logistic regression and generalized estimating equations. Results Two hundred ninety-nine patients with NJSA affecting 321 joints were included. Among those receiving preoperative antibiotics, yield significantly decreased from 68.0% at POC to 57.1% at OC (P <.001). In contrast, for patients without preoperative antibiotics there was a non-significant increase in yield from 60.9% at POC to 67.4% at OC (P =.244). In a logistic regression model for paired data, preoperative antibiotic exposure was more likely to decrease OC yield compared to non-exposure (odds ratio [OR] = 2.12; 95% confidence interval [CI] = 1.24–3.64; P =.006). Within the preoperative antibiotic group, additional antibiotic doses and earlier antibiotic initiation were associated with lower OC yield. Conclusions In patients with NJSA, preoperative antibiotic exposure resulted in a significant decrease in microbiologic yield of operative cultures as compared to patients in whom antibiotic therapy was held prior to obtaining operative cultures. [ABSTRACT FROM AUTHOR]

Background: In addition to their classic genomic effects, glucocorticoids also manifest rapid non genomic effects. We speculate that dexamethasone has the potential prompt onset of analgesic effects. The objective of this study is to investigate the influence of a single preoperative dose of dexamethasone on the half maximal effective concentration (EC50) of remifentanil when combined with dexmedetomidine for pain relief during pancreatic extracorporeal shockwave lithotripsy (P-ESWL). Methods: A total of 60 patients undergoing P-ESWL were enrolled and randomized at 1:1 ratio into the dexamethasone (DXM) group and the placebo group. Before anesthesia induction, patients in DXM group received an intravenous injection of 8 mg dexamethasone, while subjects in placebo group received an equal dose of physiological saline. Monitored anesthesia care (MAC) was performed based on remifentanil in combination with dexmedetomidine. Remifentanil was administered by TCI with an initial target concentration of 2.5 µg/mL for both groups. A positive response was defined as that VAS score > 3 by the patient at any time during the procedure. Subsequent target concentrations were adjusted by Dixon up-down sequential method, where dose modifications were performed by 0.3 ng/mL intervals, based on the response of the previous patient. The EC50 of remifentanil for pain relief during P-ESWL treatment was calculated using Dixon's up-and-down method. Hemodynamic variables, oxygen saturation and adverse events were also recorded. Results: Dixon up-and-down method revealed that the EC50 of remifentanil was significantly higher in placebo group (2.65 ± 0.28 ng/mL) than in DXM group (2.02 ± 0.23 ng/ml) (P < 0.001). Hemodynamic parameter exhibited a significant decrease in mean arterial pressure (MAP) and heart rate (HR) before and after induction in placebo group; however, data of the two groups were comparable (P>0.05). Less adverse events occurred in DXM group, including the incidence of postoperative nausea and vomiting (PONV) and analgesia requirement with in the first 24 h following the procedure at ward. Conclusion: Dexamethasone exerted analgesic effects with a rapid onset, and patients received dexamethasone 8 mg preoperative had a lower required EC50 of remifentanil during P-ESWL. It is also associated with reduced PONV in addition to reduced postoperative analgesic consumption in the first postoperative 24 h. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2300078171) on 30/11/2023. [ABSTRACT FROM AUTHOR]

Background: The addition of epinephrine to arthroscopic irrigation fluid has been shown to improve surgeon-rated visual clarity during shoulder arthroscopic surgery. Subacromial injections of epinephrine are also used for this purpose. Purpose/Hypothesis: To assess the influence of a preoperative subacromial epinephrine injection on surgeon visualization during subacromial shoulder arthroscopic surgery. It was hypothesized that the epinephrine injection would improve surgeon-rated visual clarity. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A double-blind randomized controlled trial including adult patients undergoing shoulder arthroscopic surgery in the beach-chair position requiring visualization of the subacromial space was performed. Patients in the epinephrine group (n = 30) received a preoperative subacromial injection of bupivacaine and epinephrine, and those in the control group (n = 30) received a preoperative subacromial injection of bupivacaine. Epinephrine was added to the first 10 L of arthroscopic irrigation fluid in all patients. The primary outcome was surgeon-rated visual clarity throughout the procedure that was recorded at the end of the procedure using a visual analog scale (VAS) scored from 0 (worst) to 10 (best). Secondary outcomes included an increase in pump pressure during the procedure, total operative time, and the intraoperative use of blood pressure–modulating medications. Results: Rotator cuff repair was performed in 88.3% of patients (25/30 epinephrine; 28/30 control), with multiple procedures performed in 85.0% of patients (23/30 epinephrine; 27/30 control). The VAS score for visual clarity was slightly better in the epinephrine group compared with the control group, although the difference was neither statistically nor clinically significant (8.3 ± 1.4 vs 7.5 ± 1.8, respectively; P =.09). There was no difference between the epinephrine and control groups in the need for an increase in pump pressure to improve visualization (8/30 [26.7%] vs 7/30 [23.3%], respectively; P >.99), total operative time (62.0 ± 19.4 vs 64.0 ± 30.1 minutes, respectively; P =.90), or the intraoperative use of blood pressure–modulating medications (20/30 [66.7%] vs 17/30 [56.7%], respectively; P =.60). There were no perioperative adverse events in either group. Conclusion: The addition of a subacromial epinephrine injection before shoulder arthroscopic surgery resulted in a small improvement in visual clarity that was neither statistically nor clinically significant, with no adverse effects reported in this study. Registration: NCT05244525 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

Background: Off-label intranasal administration of injectable dexmedetomidine has been widely applied in the pediatric sedation setting. However, the development of an improved drug delivery system that is easy to use is needed. We developed a novel dexmedetomidine nasal spray that can be administered directly without dilution or configuration for pediatric pre-anesthetic sedation. This nasal spray has a fixed dose and is stable during storage. To the best of our knowledge, this is the first licensed nasal spray preparation of dexmedetomidine worldwide. Objective: To evaluate the pre-anesthetic sedation efficacy and safety of the novel dexmedetomidine nasal spray in children. Methods: The study was conducted at 11 sites in China between 24 November 2021 and 20 May 2022 and was registered in ClinicalTrials.gov (NCT05111431, first registration date: 20/10/2021). Subjects (n = 159) between 2 and 6 years old who were to undergo elective surgery were randomized to the dexmedetomidine group (n = 107) or the placebo group (n = 52) in a 2:1 ratio. The dosage was 30 µg or 50 µg based on the stratified body weight. The primary outcome measure was the proportion of subjects who achieved the desired child-parent separation and Ramsay scale ≥ 3 within 45 min of administration. Safety was monitored via the assessments of adverse events, blood pressure, heart rate, respiratory rate and blood oxygen saturation. Results: The proportion of subjects achieving desired parental separation and Ramsay scale ≥ 3 within 45 min was significantly higher in the dexmedetomidine group (94.4%) vs the placebo group (32.0%) (P < 0.0001). As compared with placebo, dexmedetomidine treatment led to more subjects achieving Ramsay scale ≥ 3 or UMSS ≥ 2, and shorter time to reach desired parental separation, Ramsay scale ≥ 3 and UMSS ≥ 2 (all P < 0.0001). Adverse events were reported in 90.7% and 84.0% of subjects in the dexmedetomidine and placebo groups, respectively, and all the events were mild or moderate in severity. Conclusions: This novel dexmedetomidine nasal spray presented effective pre-anesthetic sedation in children with a tolerable safety profile. [ABSTRACT FROM AUTHOR]

Background Daratumumab-hyaluronidase-fihj (Dara-SQ) is frequently used in the treatment of plasma cell disorders and is associated with improved outcomes. Dara-SQ was shown to be non-inferior to intravenous daratumumab (Dara-IV) in efficacy, safety, and associated with fewer administration-related reactions (ARRs). Despite the lower ARR risk with Dara-SQ, package labeling still recommends indefinite premedication. In this study, we investigated the safety of premedication discontinuation after one cycle of Dara-SQ. Materials and Methods This pre-post interventional quality improvement study included all patients aged 18 years and older diagnosed with multiple myeloma or light chain (AL) amyloidosis who received at least one dose of Dara-SQ. Patients in Arm 1 received Dara-SQ per package labeling, while patients in Arm 2 had premedication omitted (excluding dexamethasone) after cycle 1. The primary endpoint was the incidence of ARR after cycle 1. Overall ARR rate and therapy time saved were also evaluated. Results A total of 102 patients (63 in Arm 1 and 39 in Arm 2) were included. There were zero reactions in either arm after cycle 1 across 1479 Dara-SQ doses administered over a 30-month period with or without premedication omission. The overall ARR rate was 2.9% (3/102), which all occurred prior to premedication omission. Therapy timed saved from premedication omission was 194 hours in a 6-month period, equating to approximately $140 000 USD. Conclusion ARRs to Dara-SQ were rare, mild, and occurred during cycle 1 prior to premedication omission. Omission of noncorticosteroid premedication is safe, feasible, and carries substantial time and cost savings for patients and infusion centers. [ABSTRACT FROM AUTHOR]

Background: More than 60% children exhibit anxiety before undergoing an anesthetic‐surgical procedure, particularly among pre‐school paediatric patients. Oral midazolam can provide procedural sedation for children prior to anesthesia. However, extemporaneous solutions of midazolam are usually prepared from injectable drug solutions, leading to inconsistent efficacy due to variable preparation methods. Xiaoerjing® is the first commercially available oral formulation of midazolam for procedural sedation in children in China. Despite the recommended dosage range of 0.25–0.5 mg/kg, its effective dose is still largely unknown. Aim: To determine the 95% effective dose (ED95) of midazolam oral solution (Xiaoerjing®) for alleviating preoperative anxiety in children prior to mask induction of general anesthesia. Design: The study included 61 children between the ages of 1 and 6 years undergoing elective surgery under general anesthesia. The first patient received a single dose of 0.5 mg/kg midazolam oral solution, which was adjusted for subsequent patients using the biased coin design method based on their response to the previous dose. Doses were increased or decreased at the rate of 0.1 mg/kg. An effective response was defined as having a modified Ramsay sedation score ≥3a, separation anxiety score ≤2, and mask acceptance score ≤2 during inhalational anesthesia induction. Results: Fifty‐six children were included in the final analysis. Of those, sedation was successful in 50 patients, with a median separation time of 15 (IQR: 25) min. Midazolam oral solution has an ED95 of 0.8254 mg/kg (95% CI: 0.6915–0.8700 mg/kg) for relieving preoperative anxiety in children. No adverse events occurred following drug administration. Conclusion: Midazolam oral solution is a safe and effective medication for relieving preoperative anxiety in children. The ED95 of a single oral dose of midazolam oral solution is 0.8254 mg/kg (95% CI: 0.6915–0.8700 mg/kg). [ABSTRACT FROM AUTHOR]

PURPOSE: Premedication, including a histamine-1 receptor (H1) antagonist, is recommended to all patients treated with paclitaxel chemotherapy to reduce the incidence of hypersensitivity reactions (HSRs). However, the scientific basis for this premedication is not robust, which provides opportunities for optimization. Substitution of intravenously administered first-generation H1 antagonist for orally administered second-generation H1 antagonist could reduce side effects, and improve efficiency and sustainability. This study investigates the efficacy and safety of substituting intravenous clemastine for oral cetirizine as prophylaxis for paclitaxel-induced HSRs. METHODS: This single-center, prospective, noninferiority study compares a historic cohort receiving a premedication regimen with intravenous clemastine to a prospective cohort receiving oral cetirizine. Primary end point of the study is HSR grade ≥3. The difference in incidence was calculated together with the 90% CI. We determined that the two-sided 90% CI of HSR grade ≥3 incidence in the oral cetirizine cohort should not be more than 4% higher (ie, the noninferiority margin) compared with the intravenous clemastine cohort. RESULTS: Two hundred and twelve patients were included in the oral cetirizine cohort (June 2022 and May 2023) and 183 in the intravenous clemastine cohort. HSR grade ≥3 incidence was 1.6% (n = 3) in the intravenous clemastine cohort and 0.5% (n = 1) in the oral cetirizine cohort, resulting in a difference of –1.2% (90% CI, –3.4 to 1.1). CONCLUSION: Premedication containing oral cetirizine is as safe as premedication containing intravenous clemastine in preventing paclitaxel-induced HSR grade ≥3. These findings could contribute to optimization of care for patients and improve efficiency and sustainability. Oral cetirizine is a nonsedative, easy, and effective alternative for IV antihistamines before paclitaxel. [ABSTRACT FROM AUTHOR]

Background: The management of preoperative anxiety in pediatric patients, as well as its implications, has remained challenging for anesthesiologists. In this study, we compared the safety and efficacy of intranasal dexmedetomidine, midazolam, and ketamine as surgical premedication in children.Methods: This double-blinded randomized clinical trial was conducted at two tertiary hospitals in January 2014, on 90 children aged between 2-7 years old. The participants’ American Society of Anesthesiologists (ASA) physical status was I or II, and they were scheduled for elective unilateral inguinal herniorrhaphy. Using the block randomization method, the patients were randomly assigned to three groups, each receiving intranasal dexmedetomidine (2 µg/Kg), midazolam (0.2 mg/Kg), and ketamine (8 mg/Kg) 60 min before induction of anesthesia. Anxiety and sedation state were evaluated before drug administration, and then every 10 min for the next 50 min. Parental separation anxiety, mask acceptance, postoperative agitation, pain, nausea, and vomiting were also recorded and compared between these groups. All the statistical analyses were performed using SPSS software (version 21.0). P

Background: Premedication administration to patients who are to receive blood transfusions continues despite evidence of a lack of benefit when given to prevent febrile nonhemolytic or mild allergic transfusion reactions. Reviews of ordering practices and staff surveys on an adult inpatient hematology–oncology unit in our multisite oncology medical center indicated a lack of standardization and overuse of premedication in blood transfusions and a lack of knowledge of when it was appropriate to use premedication. Methods: A literature search was performed, and the evidence led to a proposal for a quality improvement (QI) project focused on development of an evidence-based algorithm to guide clinicians in when to administer which premedication, development of clear documentation for premedication plans, integration of the documented premedication plans into electronic orders for blood products, and staff education. Interventions included a hospital-wide algorithm and an electronic order to be integrated with a premedication plan for each patient on the adult hematology–oncology unit. Results: Seven months after implementation of the intervention, premedication use among patients decreased by 57.6%, and the transfusion reaction rate decreased from 1% to 0.8%. Staff knowledge as measured by responses to pre- and postintervention surveys on the appropriate use of premedication also improved. Conclusion: Evidence-based interventions can reduce the incidence of premedication use in patients receiving blood transfusions. To address premedication overuse in blood transfusions at their institution, the authors developed and implemented an evidence-based algorithm to guide clinicians in when to administer premedication and an electronic order to be integrated with a premedication plan for each patient on an adult hematology–oncology unit. [ABSTRACT FROM AUTHOR]

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Background: In people with intellectual disabilities and/or autism spectrum disorder, oral midazolam (OM) is very effective as premedication for facilitating medical treatment. In this retrospective study, we investigated the optimal dosage of OM for premedication. Methods: Patients with intellectual disability and/or autism spectrum disorder who were given OM as a premedication were selected from anaesthesia records. The primary outcome variable was the dose of OM (mg/kg) required to produce an adequate sedation. Results: The mean OM dose required was 0.32 ± 0.10 mg/kg. The required OM dose decreased significantly as age and weight increased, and age and weight were also shown to be significantly associated with the dose of OM in the multivariate linear regression analysis. Conclusion: The dosage of OM to achieve adequate sedation should decrease as the patient ages. Furthermore, adequate sedation can be achieved with even lower doses of OM in obese people. [ABSTRACT FROM AUTHOR]

Background: The management of preoperative anxiety in pediatric patients, as well as its implications, has remained challenging for anesthesiologists. In this study, we compared the safety and efficacy of intranasal dexmedetomidine, midazolam, and ketamine as surgical premedication in children. Methods: This double-blinded randomized clinical trial was conducted at two tertiary hospitals in January 2014, on 90 children aged between 2-7 years old. The participants' American Society of Anesthesiologists (ASA) physical status was I or II, and they were scheduled for elective unilateral inguinal herniorrhaphy. Using the block randomization method, the patients were randomly assigned to three groups, each receiving intranasal dexmedetomidine (2 µg/Kg), midazolam (0.2 mg/Kg), and ketamine (8 mg/Kg) 60 min before induction of anesthesia. Anxiety and sedation state were evaluated before drug administration, and then every 10 min for the next 50 min. Parental separation anxiety, mask acceptance, postoperative agitation, pain, nausea, and vomiting were also recorded and compared between these groups. All the statistical analyses were performed using SPSS software (version 21.0). P<0.05 was considered statistically significant. Results: Ketamine indicated the strongest sedative effect 10, 20, and 30 min after administration of premedication (P<0.001, P=0.03, P=0.01, respectively). However, dexmedetomidine was more effective than other drugs after 40 and 50 min (P<0.001). Other variables indicated no statistically significant difference. Conclusion: In case of emergencies, intranasal ketamine, with the shortest time of action, could be administered. Intranasal dexmedetomidine, which was revealed to be the most potent drug in this study, could be administrated 40-50 min before elective pediatric surgeries. Trial registration number: IRCT2013081614372N1. [ABSTRACT FROM AUTHOR]

Objective: The aim of this prospective, double-blind, randomized controlled trial was to compare the effect of oral premedication of meloxicam, ketorolac, dexamethasone, ibuprofen, or placebo on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Method and materials: Two hundred and fifty emergency patients in moderate to severe pain diagnosed with symptomatic irreversible pulpitis of a mandibular first or second molar randomly received, in a double-blind manner, identical capsules containing either meloxicam 7.5 mg, ketorolac 10 mg, dexamethasone 0.5 mg, ibuprofen 600 mg, or placebo 60 minutes before the administration of an IANB. Profound lip numbness was assessed after 15 minutes. Access cavities were then prepared and success of IANB was defined as no or mild pain (Heft-Parker visual analog scale recordings) during access preparation and root canal instrumentation. The data were analyzed using chi-square and Kruskal-Wallis tests. Results: The overall success rates for the meloxicam 7.5 mg, ketorolac 10 mg, dexamethasone 0.5 mg, and ibuprofen 600 mg groups were 52%, 64%, 54%, and 58%, respectively, with no significant differences in success rates among the premedications groups (P > .05). However, the tested premedications revealed significant differences compared with the placebo group (32% success rate) (P < .05). Conclusion: Premedication with meloxicam, ketorolac, dexamethasone, and ibuprofen increased the efficacy of IANB in mandibular molars with symptomatic irreversible pulpitis. [ABSTRACT FROM AUTHOR]

Background: The Erector spinae plane block (ESPB) reduces postoperative pain after several types of abdominal laparoscopic surgeries. There is sparse data on the effect of ESPB in laparoscopic ventral hernia repair. The purpose of this study was to test the postoperative analgesic efficacy of an ESPB for this procedure. Methods: In this prospective, double-blind, randomized controlled study, adult patients undergoing laparoscopic ventral hernia repair were randomly assigned to either bilateral preoperative ESPB with catheters at the level of Th7 (2 × 30 ml of either 2.5 mg/ml ropivacaine or saline), with postoperative catheter top ups every 6 h for 24 h. The primary outcome was rescue opioid consumption during the first hour postoperatively. Secondary outcomes were total opioid consumption at 4 h and 24 h, pain scores, nausea, sedation, as well as Quality of Recovery 15 (QoR-15) and the EuroQol-5 Dimensions (EQ-5D-5L) during the first week. Results: In total, 64 patients were included in the primary outcome measure. There was no significant difference in rescue opioid consumption (oral morphine equivalents (OME)) at one hour postoperatively, with the ESPB group 26.9 ± 17.1 mg versus 32.4 ± 24.3 mg (mean ± SD) in the placebo group (p= 0.27). There were no significant differences concerning the secondary outcomes during the seven-day observation period. Seven patients received a rescue block postoperatively, providing analgesia in five patients. Conclusion: We found no difference in measured outcomes between ESPB and placebo in laparoscopic ventral hernia repair. Future studies may evaluate whether a block performed using higher concentration and/or at a different thoracic level provides more analgesic efficacy. Trial registration: NCT04438369; 18/06/2020. [ABSTRACT FROM AUTHOR]

Background: Propofol for anesthesia has become increasingly popular for endoscopic procedures. However, pain on propofol injection (POPI) remains an issue with administration. The primary endpoint of this study was to identify patient characteristics and factors, such as IV site and gauge, that could predict the occurrence of POPI. Methods: This was a prospective chart review study of 291 patients undergoing endoscopic procedures. The patient's demographics, intravenous (IV) site, and gauge were extrapolated. POPI was scored 0–3: 0 for no pain, 1 for minimal discomfort or awareness of sensation, 2 for discomfort but manageable/tolerable, and 3 for severe discomfort with writhing. Results: 291 patient charts were reviewed. One patient was excluded for a lower extremity IV site. 225 (77.6%) had no pain, 48 (16.6%) grade 1 pain, 16 (5.5%) grade 2 pain, and 1 (0.3%) grade 3 pain. 137, 13, and 140 patients respectively had antecubital (AC), forearm, and hand IVs. Zero patients with an AC IV experienced a score greater than 1. Compared to AC, forearm IVs with pain of 2–3 had a univariate odds ratio (OR) of 11.3 (0.66,1.92; p-value < 0.001), and hand IVs had a univariate OR of 18.8 (2.46,143.3; p-value < 0.001) with a multivariable OR 15.2 (1.93,118.9; p-value 0.004). Patients with anxiety/depression and pain had a univariate OR 2.31 (1.09, 7.27; p-value 0.031) with a multivariable OR 2.85 (1.06, 7.74; p-value 0.039). SSRI/SNRI use had a univariate OR 1.56 (0.57,4.28; p-value 0.38). Alcohol use had a univariate OR 1.24 (0.39,3.91; p-value 0.71). Narcotic use had a Univariate OR 6.18 (1.49,25.6; p-value 0.012). Diabetic patients had a univariate OR of 1.42 (0.45,4.48; p-value 0.55). Chronic pain had a univariate OR of 3.11 (1.04,9.28; p-value 0.042). Females had a univariate OR 0.98 (0.37,2.63; p-value 0.95). Conclusion: This study identified potential characteristics for having POPI. The incidence of POPI was statistically significant in patients with hand and forearm IVs compared to AC IV sites, larger IV gauges, history of depression/anxiety, history of chronic narcotic use, fibromyalgia, and chronic pain syndromes. This shows the potential of premedicating with analgesics or using AC sites on these select patients to help reduce the risk of POPI. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to evaluate the potential of astragalus polysaccharide (APS) pretreatment in enhancing the homing and anti-peritoneal fibrosis capabilities of bone marrow mesenchymal stromal cells (BMSCs) and to elucidate the underlying mechanisms. Methods: Forty male Sprague-Dawley rats were allocated into four groups: control, peritoneal dialysis fluid (PDF), PDF + BMSCs, and PDF + APSBMSCs (APS-pre-treated BMSCs). A peritoneal fibrosis model was induced using PDF. Dil-labeled BMSCs were administered intravenously. Post-transplantation, BMSC homing to the peritoneum and pathological alterations were assessed. Stromal cell-derived factor-1 (SDF-1) levels were quantified via enzyme-linked immunosorbent assay (ELISA), while CXCR4 expression in BMSCs was determined using PCR and immunofluorescence. Additionally, a co-culture system involving BMSCs and peritoneal mesothelial cells (PMCs) was established using a Transwell setup to examine the in vitro effects of APS on BMSC migration and therapeutic efficacy, with the CXCR4 inhibitor AMD3100 deployed to dissect the role of the SDF-1/CXCR4 axis and its downstream impacts. Results: In vivo and in vitro experiments confirmed that APS pre-treatment notably facilitated the targeted homing of BMSCs to the peritoneal tissue of PDF-treated rats, thereby amplifying their therapeutic impact. PDF exposure markedly increased SDF-1 levels in peritoneal and serum samples, which encouraged the migration of CXCR4-positive BMSCs. Inhibition of the SDF-1/CXCR4 axis through AMD3100 application diminished BMSC migration, consequently attenuating their therapeutic response to peritoneal mesenchyme-to-mesothelial transition (MMT). Furthermore, APS upregulated CXCR4 expression in BMSCs, intensified the activation of the SDF-1/CXCR4 axis's downstream pathways, and partially reversed the AMD3100-induced effects. Conclusion: APS augments the SDF-1/CXCR4 axis's downstream pathway activation by increasing CXCR4 expression in BMSCs. This action bolsters the targeted homing of BMSCs to the peritoneal tissue and amplifies their suppressive influence on MMT, thereby improving peritoneal fibrosis. [ABSTRACT FROM AUTHOR]

Introduction: Cannabinoids show great therapeutic potential, but their effect on anesthesia still remains unclear. Use of chronic recreational Cannabis in humans undergoing anesthetic procedures tends to require a higher dose when compared to non-users. On the other hand, studies on rodents and dogs have shown that cannabinoid agonists may potentiate certain anesthetics. This contrast of effects possibly occurs due to different time lengths of administration of different phytocannabinoids at different doses, and their distinct effects on the Endocannabinoid System, which is also affected by anesthetics such as propofol and isoflurane. Methods: Twenty-seven healthy male dogs, client-owned, ranging from 1 to 7 years, and from 5 to 35 kg were selected, mean weight 15.03±7.39 kg, with owners volunteering their animals to participate in the research performed in the Federal University of Santa Catarina (UFSC). Dogs were randomized into 3 groups. The Control Group (CON, n = 9), receiving only Extra Virgin Olive Oil, the same oil-base used in the treatment groups. Group 2 (G2, n = 9) received 2 mg/kg of total phytocannabinoids, and Group 3 (G3, n = 9) received 6 mg/kg of total phytocannabinoids. All groups received their treatments transmucosally, 75 min before their induction with propofol. Heart and respiratory rate, blood pressure, temperature and sedation were evaluated prior to, and at 30, 60, and 75 min after administration of the fsCBD-rich extract or Placebo extract. Preanesthetic medication protocol was also included across all treatment groups, 15 min before induction. Parametric data was analyzed with one-way ANOVA, followed by Student-Newman-Keuls (SNK) if significant statistical differences were found. Non-parametric data was analyzed using Friedman's test, followed by Dunn test for comparisons between all timepoints in the same group. Kruskal-Wallis followed by Dunn was utilized for between groups comparisons. Propofol dose necessary for induction was analyzed through One-way ANOVA followed by Tukey's Multiple Comparisons Test, using Instat by Graphpad, and differences were considered statistically significant when p < 0.05. Our analysis assessed if statistical significance was present between time points in the same group, and between groups in the same time points. Results: In our study, 6 mg/kg of total phytocannabinoids were able to reduce the dose of propofol necessary for induction by 23% when compared to the control group. The fsCBD-rich extract did not produce significant sedation within or between groups, although statistically significant differences in heart rate and systolic blood pressure were found. Discussion: Our findings indicate that phytocannabinoids could be an adjunct option in anesthesia, although further research is necessary to better confirm this data. Additionally, further research is needed to determine the best dosage, delivery method, time for administration, ideal molecular profile for desired effects, safety, drug-drug interactions, and transurgical effects. [ABSTRACT FROM AUTHOR]

Objective: For true clean-contaminated head and neck procedures, the literature supports ≤24 hours of perioperative antibiotics. However, there are certain otolaryngology procedures with low surgical site infection (SSI) risk for which there is negligible benefit from antibiotic prophylaxis. The objective of this evaluation was to describe antibiotic use and adherence to evidence-based institutional guidelines in low-risk head and neck procedures. Methods: This was a single-center, retrospective cohort study of patients undergoing low-risk clean-contaminated head and neck procedures wherein antibiotic prophylaxis was not indicated, based on evidence-based institutional guidelines. Results: Among the 291 included patients, perioperative antibiotics were unnecessarily administered in 29% of patients. Among patients who received antibiotics, 76% received preoperative antibiotics and 41% received postoperative antibiotics, for a median duration of 7 days. There were no significant differences in SSIs, mortality, and length of stay for those receiving perioperative antibiotics versus those not receiving perioperative antibiotics. Conclusion: These data highlight the need for antibiotic stewardship interventions and partnerships between antibiotic stewardship teams and surgical services. [ABSTRACT FROM AUTHOR]

A intraperitoneal anesthesia is a form of local infiltrative anesthesia widely adopted in Veterinary Medicine for ovariohysterectomy surgeries, offering benefits such as reduced postoperative pain. In this study, a case of a healthy 10-year-old, 6.1 kg female dog undergoing ovariohysterectomy and nodulectomy was reported. Pre-anesthetic medication included acepromazine (0.025 mg/kg) and methadone (0.3 mg/kg), with induction achieved using propofol (3 mg/kg), lidocaine (1 mg/kg), and ketamine (2 mg/kg), maintained with isoflurane. Intraoperative medications administered were fentanyl (2.5 µg/kg), dipyrone (25 mg/kg), meloxicam (0.1 mg/kg), and amoxicillin (0.1 mg/kg). Bupivacaine (1 mg/kg) was instilled at the end, following literature studies on the aforementioned technique. Vital parameters remained stable throughout the intraoperative period, and the patient's anesthetic recovery was uncomplicated with no signs of pain. Ultimately, the use of intraperitoneal anesthesia with bupivacaine proved effective in reducing postoperative pain, underscoring the importance of multimodal anesthetic protocols for comfortable and successful recovery. [ABSTRACT FROM AUTHOR]

Purpose Use of high-risk medications preoperatively may increase the incidence of postoperative complications. Available literature evaluating pharmacists' role in preoperative medication review is limited, and guidance is not currently available on which patients should have a medication review performed by a pharmacist before surgery. A preoperative rehabilitation pilot project in which clinical pharmacists reviewed medication profiles before scheduled surgeries was developed. This review aimed to evaluate pharmacists' role in reviewing medication profiles preoperatively and to identify specific patient factors that suggest a medication review is warranted. Methods This retrospective review utilized the electronic medical records of nonfrail adults undergoing preplanned surgeries enrolled in the pilot project from August 2021 to April 2022. Endpoints were determined using descriptive statistics and regression models. A multivariate analysis was performed evaluating high-risk medications and VIONE (Vital, Important, Optional, Not indicated, and Every medication has an indication) polypharmacy risk score. Results Forty patients were included, with at least one recommendation made in 83% of chart reviews. Many patients (95%) were taking at least one high-risk medication. Of the high-risk medication classes evaluated independently, only antiplatelets were predictive of pharmacy intervention (P = 0.01). Only high-risk medications were independently predictive of pharmacist intervention (P < 0.01) when multivariate analysis was performed. Conclusion Pharmacists made a recommendation in the majority of medication reviews and were most likely to make a recommendation in patients taking high-risk medications. A larger sample size may provide more insight regarding patient-specific factors warranting a preoperative medication review. [ABSTRACT FROM AUTHOR]

Introduction: Cetuximab, an IgG1 monoclonal antibody, is utilized in the treatment of metastatic colorectal cancer and squamous cell head and neck cancers. Due to the risk of hypersensitivity reactions, standard premedication with a histamine-1 (H-1) antagonist is recommended prior to administration, however, there is less guidance for premedication strategies to assist with rechallenge after infusion reactions. Here, we describe two cases of successful cetuximab treatment after Grade 2 reactions, in addition to risk factors and proposed premedication strategies for successful rechallenge. Case report: Two patients who experienced Grade 2 hypersensitivity reactions were both successfully rechallenged with increased premedications 1–2 weeks after initial infusions. The first patient was a 56-year-old male diagnosed with metastatic colorectal cancer receiving cetuximab as part of a clinical trial. The second patient was a 73-year-old male diagnosed with head and neck cancer receiving cetuximab as part of standard of care concurrent with radiation. Management and outcome: Each patient was rechallenged with an increased premedication strategy including dexamethasone, famotidine, diphenhydramine, and acetaminophen in addition to reducing the infusion rate. Both patients either continued treatment or successfully completed therapy, without any additional infusion-related reactions. Discussion: We aimed to review risk factors related to cetuximab infusion reactions and propose a premedication strategy for rechallenge postreaction. Known risk factors include male sex and the accumulation of cetuximab-specific IgE. These may be mitigated by the addition of increased premedication with dexamethasone and famotidine with concurrent reduced infusion rate. [ABSTRACT FROM AUTHOR]

Background: This prospective, randomized, double-blind trial was done to compare intranasal dexmedetomidine and intranasal midazolam as premedication for sedation and ease of child-parent separation in pediatric patients of tetralogy of Fallot (TOF) undergoing corrective cardiac surgery. Materials and Methods : Forty children with TOF, between 1 and 10 years, undergoing corrective cardiac surgery were included in the study and, after randomization, were given intranasal midazolam (0.2 mg/kg) or intranasal dexmedetomidine (1 µg/kg), 30 min before shifting to the operation room (OR). Patients were assessed for sedation and child-parent separation, along with hemodynamic parameters, respiratory rate, and oxygen saturation (SpO2) 30 min after drug administration, at the time of shifting inside the OR, and at the time of induction of anesthesia. Results: Both groups had comparable child-parent scores, hemodynamic parameters, SpO2, and respiratory rate. However, the dexmedetomidine group had significantly better sedation levels than the midazolam group patients at the time of shifting inside the OR (dexmedetomidine group: 3.55 ± 0.82 vs. midazolam group: 2.80 ± 0.83; P = 0.007) and at the time of induction of anesthesia (dexmedetomidine group: 3.40 ± 0.75 vs. midazolam group: 2.70 ± 0.86; P = 0.009). Conclusion: Intranasal dexmedetomidine provides better sedation than midazolam, with similar child-parent separation scores and hemodynamic parameters, respiratory rate, and SpO2. No adverse events were observed in both groups. A study on a larger population will help in further establishing the safety and superiority of dexmedetomidine and will further its regular use as an intranasal premedication. [ABSTRACT FROM AUTHOR]

Background: Thromboembolic events related to invasive electrophysiology studies, while rare, can have devastating consequences. Use of systemic anticoagulation for a pediatric or adult‐congenital invasive electrophysiology study is recommended, however there is no established standard of practice in this population. Objective: To report on procedural practices for thromboembolism prophylaxis during invasive electrophysiology studies for pediatric patients and adults with congenital heart disease. Methods: An anonymous web‐based survey was sent to the members of the Pediatric and Congenital Electrophysiology Society. The survey focused on pre‐procedural, intra‐procedural, and post‐procedural thromboembolism prophylaxis practices during invasive electrophysiology studies. Significant practice variation was defined as <90% concordance among respondents. Results: Survey was completed by 73 members; 52 (71%) practicing in the United States, 65 (89%) practicing in an academic institution, and 14 (19%) in an institution that performs more than 200 invasive electrophysiology procedures annually. Responses showed significant variation in practice. Prior to an invasive electrophysiology procedure, 25% discontinue aspirin while 47% discontinue anticoagulants. Heparin is given for all procedures by 32%. When heparin is administered, the first dose is given by 32% after sheaths are placed, 42% after crossing into the systemic atrium, and 26% just prior to systemic‐side ablation. Most target an activated clotting time between 200–300 seconds. Post systemic‐side ablation, 58% do not initiate a heparin infusion. Post‐procedural oral agents were initiated on day of procedure by 34% of respondents and on post‐procedure day 1 by 53%. If treating with aspirin, 74% use low‐dose (3–5 mg/kg or 81 mg daily), and 68% treat for 4–6 weeks. Conclusion: There is significant variation in thromboembolism prophylaxis for invasive EP studies among pediatric and congenital electrophysiologists. Further studies are needed to optimize the management of thromboembolism prophylaxis in this population. [ABSTRACT FROM AUTHOR]

Background: Laparoscopic cholecystectomy pain is a sensory and emotional experience connected with actual or potential tissue damage. Effective pain control is quite important, with around 70% of patients still complaining of moderate-to-severe pain postoperatively. Uncontrolled perioperative pain may raise patient morbidity and mortality rates. Both gabapentin and clonidine as premeditated can be easily administered have minimal side effects, are easily available at a low price, both them have a sedative effect that can decrease anxiety and they can blunt the stress response. Moreover, both drugs have anti-nociceptive effects that may be beneficial for controlling postoperating pain which is the basis of our current study. Aims: This study aims to compare the efficacy of oral clonidine with gabapentin before induction of anesthesia in attenuating hemodynamic stress response to laryngoscopy, intubation, and carbon dioxide pneumoperitoneum in laparoscopic cholecystectomy and to compare the efficacy of oral clonidine with oral gabapentin for postoperative pain control. Materials and Methods: Hundred patients undergoing laparoscopic surgery and qualifying inclusion criteria were randomly allocated into two groups each containing 50 patients. Group I patients were given Tab. Clonidine (300 μg) and Group II patients were given tablet Gabapentin (600 mg) orally 60 min before induction of general anesthesia. Hemodynamic changes and the incidence of postoperative pain in both groups were measured and compared. Results: Hemodynamic blunting to pressor stress of laryngoscopy and intubation was seen in both groups with better results obtained in the group receiving clonidine in the form of lesser variations in heart rate, systolic blood pressure, and diastolic blood pressure. Postoperative analgesia was achieved in both groups but gabapentin showed a better analgesic profile in the form of lesser Visual Analog Scale scoring and decreased utilization of rescue analgesia. Conclusion: Clonidine (300 μg) cause a greater attenuation of intraoperative hemodynamic stress responses, whereas gabapentin (600 mg) provides superior postoperative analgesia. [ABSTRACT FROM AUTHOR]

Several anti-Aβ monoclonal antibody drugs have been approved for clinical use at home and abroad recently. In order to facilitate its safe and effective treatment of anti-Aβ monoclonal antibody drugs for Alzheimer's disease (AD) in China, we present recommendations for the clinical use of anti-Aβ monoclonal antibody drugs based on existing clinical trials and the clinical practice of AD treatment with Aducanumab at Ruijin Hospital Hainan Branch, Shanghai Jiaotong University School of Medicine. The recommendations include clinical indications, pre-medication assessment and preparation, medication instructions and precautions, as well as post-medication clinical monitoring, which is aimed to furnish clinicians with comprehensive medication guidance. [ABSTRACT FROM AUTHOR]

Controlling preoperative anxiety is necessary in pediatric patients to avoid adverse effects such as emergence delirium, behavioral problems, post-traumatic stress disorder, anxiety prior to future procedures, and increased analgesic doses in the recovery room. Some patients, especially ones with behavioral issues, have a difficult time arriving at the hospital. Medications given at home can be helpful. We describe a case series of six patients who received pre-admission oral clonidine prior to arrival to the hospital. The patients were all able to enter the hospital without difficulty and the families reported less anxiety and more cooperation subjectively compared with previous experiences. Transient intraoperative hypotension was a side effect of oral clonidine, with no long-term sequelae. [ABSTRACT FROM AUTHOR]

Background: During esophagogastroduodenoscopy performed with colonoscopy, gastric and duodenal erythema, erosions, and ulcerations are often observed. This investigation was designed to review the prevalence of gastroduodenal lesions in patients who have undergone wireless capsule endoscopy using standard bowel cleansing preparations, but no endoscopy or sedation. Methods: A retrospective analysis was conducted on patients referred for capsule endoscopy. Records and capsule reports were reviewed for the patient demographics, preparation prescribed, procedural indications, and gastroduodenal findings. The preparations studied included polyethylene glycol lavage (PEG), PEG plus bisacodyl (PEG + bis), bisacodyl (bis), oral sulfate solution (OSS), and no prep. Results: Among the 1236 records, 498 (40.3%) were men and 738 (59.7%) were women. The mean age was 56 years +/− 18 years SD. The percentage of patients with lesions after any bowel preparation was 52.7% for gastric lesions and 23.6% for duodenal lesions. The percentage of patients with gastroduodenal lesions was 58.3% with prep, compared to 38.2% without prep. These findings were statistically significant, with an RR of 1.53 [1.19–1.94] (p-value = 0.00004). This difference was more pronounced in the OSS group RR of 1.65 [1.29–2.1] and bisacodyl group RR of 1.64 [1.25–2.15] compared to the PEG group RR of 0.95 [0.7–1.3]. Conclusions: This study showed that patients undergoing wireless capsule endoscopy who received bowel preparations had a significant increase in gastric and duodenal lesions. Of the preparations studied, OSS was associated with a greater number of gastroduodenal lesions, while PEG was the least associated with lesions, with an occurrence similar to the non-prep group. The clinical significance of these lesions remains undetermined. Endoscopists should be aware that preparations are associated with gastroduodenal lesions to avoid the misinterpretation and misdiagnosis of these lesions. [ABSTRACT FROM AUTHOR]

Purpose Biosimilar tumor necrosis factor inhibitors (b-TNFi) reduce healthcare costs and maintain equal efficacy when compared to their originator counterparts (o-TNFi). Current practice is to start patients on a slower standard infusion rate during the initial transition from an o-TNFi to a b-TNFi. There is a knowledge gap around switching from rapid originator infusion to rapid biosimilar infusion in the pediatric inflammatory bowel disease (IBD) population. Summary We present a case series of 8 pediatric patients with IBD who were switched from a rapid-infusion o-TNFi to a rapid-infusion b-TNFi from 2016 through 2022. Our primary interest was safety, which we evaluated based on the occurrence of infusion reactions or need for new premedications within the first 6 months of starting a b-TNFi. We also examined effectiveness through the incidence of IBD-related hospitalizations, TNFi failure, and need for co-medication or dose escalation over the same period. In our cohort, 4 patients had Crohn's disease and 4 had ulcerative colitis. All patients were switched to a biosimilar for nonmedical reasons. During the follow-up period, no patients had infusion reactions necessitating new premedications, serious adverse events, or medication nonresponse. Conclusion Patients who directly transitioned from a rapid-infusion o-TNFi to a rapid-infusion b-TNFi did not experience serious adverse events. Given the fiscal and patient experience advantages of rapid-rate infusions, larger studies are needed to consider a change in practice. [ABSTRACT FROM AUTHOR]

Background: Postpartum depression (PPD) is a common mental disease in postpartum women, which has received more and more attention in society. Ketamine has been confirmed for its rapid antidepressant effect in women with PPD. We speculate that esketamine, an enantiomer of ketamine, pretreatment during cesarean can also reduce the incidence of PPD. Methods: All the parturients enrolled in the study were randomly assigned to two groups: the esktamine group (0.2 mg/kg esketamine) and the control group (a same volume of saline). All the drugs were pumped for 40 min started from the beginning of the surgery. The Amsterdam Anxiety and Information Scale (APAIS) scores before the surgery, the Edinburgh postnatal depression scale (EPDS) scores at 4 d and 42 d after surgery, the Pain Numerical Rating Scale (NRS) scores at 6 h, 12 h, 24 h and 48 h post-operation were evaluated, as well as the adverse reactions were recorded. Results: A total of 319 parturients were analyzed in the study. The incidence of PPD (EPDS score > 9) in the esketamine group was lower than the control group at 4 days after surgery (13.8% vs 23.1%, P = 0.0430) but not 42 days after surgery (P = 0.0987). Esketamine 0.2 mg/kg could reduce the NRS score at 6 h,12 h and 24 h after surgery, as well as the use of vasoactive drugs during surgery (P < 0.05). The incidences of maternal dizziness (17.0%), blurred vision (5%), illusion (3.8%) and drowsiness (3.8%) in the esketamine group were higher than those of control group (P < 0.05). Conclusions: Intraoperative injection of esketamine (0.2 mg/kg) prevented the occurrence of depression (EPDS score > 9) at 4 days after delivery but not 42 days. Esketamine reduced the NRS scores at 6 h, 12 h and 24 h after surgery, but the occurrence of maternal side effects such as dizziness, blurred vision, drowsiness and hallucination were increased. Trial registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2100053422) on 20/11/2021. [ABSTRACT FROM AUTHOR]

The present case report aim to detail the surgical removal of a sharp foreign body of metallic origin, adhered to the inner wall of the gastric ventricle, in a specimen of Caracara plancus. The chosen surgical procedure was gastric ventriculotomy, although this is not the approach of choice since this organ has a thick muscular wall. Once adhered to the gastrointestinal tract, with most of its portion in the gastric ventricle, other accesses to the foreign body were discarded. The anesthetic approach was weighted for the species, with pre-anesthetic medication with 1 mg kg-1 butorphanol, 15 mg kg-1 esketamine and 1 mg kg-1 midazolam, intramuscularly, while anesthetic induction and maintenance was performed using sevoflurane. Monitoration was mainly performed by capnography and vascular Doppler. In the postoperative period, antibiotic therapy was instituted with 5 mg kg-1 enrofloxacin, as well as analgesic control with 0.2 mg kg-1 meloxicam and 25 mg kg-1 dipyrone, intramuscularly, at an appropriate dosage for the species. Without intercurrences, the surgical procedure performed and the pre, intra and post-surgical protocols instituted were considered efficient, since they culminated in the animal's recovery with regard to the ingestion of the metallic foreign body and its triggered gastrointestinal dysfunctions. [ABSTRACT FROM AUTHOR]

Elotuzumab in combination with dexamethasone and immunomodulating agents (IMiDs) lenalidomide or pomalidomide is 2nd to 4th line therapy for multiple myeloma. The labelled dosage of dexamethasone for use in conjunction with elotuzumab and IMiDs splits the dexamethasone dose into two administrations, one oral and one intravenous, on the days of each elotuzumab infusion. Administration of split dose dexamethasone on days of elotuzumab administration is based on the registration trials submitted for drug approval and was intended to ensure standard well-timed immunotherapy premedication using pharmacologically equivalent dexamethasone doses for both study arms. Administration of dexamethasone in the manner delineated by the elotuzumab product label adds complexity to the delivery of care. This commentary provides an empirical assessment of established medication safety and effectiveness which supports administration of dexamethasone standard intermittent dose instead of the split dose approach delineated on elotuzumab package insert. Simplification of regimen administration improves medication adherence, reduces the risk of inadvertent omission or duplication of medication therapy, and improves the workflow required for delivery of care. [ABSTRACT FROM AUTHOR]

Background: Premedication of cancer therapy against nausea and vomiting (NV) and hypersensitivity reaction (HS) is essential for good patient management. However, this prescription is not always optimal. Today, as a large part of cancer therapies are administered in day hospitals (DH), premedication taken on the day of the cancer treatment is injected as a 30-min infusion. Objective: To assess compliance with recommendations for premedication prescription and intake; to analyse patient attitude about switching to exclusively oral forms taken at home. Method: The study is conducted in the medical oncology DH of a French Hospital from 17 January to 25 February 2022. The data collection is carried out as an individual interview, associated with the distribution of two questionnaires. Data are coupled with the premedication set up on our software and the last medical report. Intakes are considered optimal when recommendations, tolerance, background, and adherence of the patient are taken into account. Results: Seventy patients were included for interviews. Regarding software prescriptions, our configuration was consistent with recommendations in 100% of cases for HS and 37% for NV. Intakes were compliant in 51.4% of cases, non-compliant in 17.1% and debatable in 31.5%. Disparities between the practices of different physicians were identified. Regarding the feasibility of oral substitution, it could concern 63.5% of patients. Conclusion: This work makes it possible to improve the management of all patients and to make the operation of the care unit more fluid. [ABSTRACT FROM AUTHOR]

Background & Objective: Studies have shown contradictory results regarding the use of pregabalin and melatonin as analgesic agents. Because the analgesic effects of these drugs as preemptive have not been compared in abdominal hysterectomy, one of the most common surgical procedures in women with moderate to severe pain, under general anesthesia. The aim of this study was to compare the pretreatment effects of melatonin and pregabalin on postoperative pain intensity in total abdominal hysterectomy (TAH). Materials & Methods: Ninety Patients were randomly divided into three groups (N=30): the first group received oral melatonin (6 mg), the second group received pregabalin (50 mg), and the third one who took no drug. Serum melatonin and betaendorphin levels were measured before and after the surgery. Pain intensity was assessed by the Numerical Rating Scale at 1,6,12, and 24 hours after the surgeries. Results: At 12 hrs after the surgery, mean pain intensity in the melatonin group was significantly lower than the pregabalin group, and in the pregabalin group was significantly lower than the third group (P<0.05). At 24 hrs after the TAH, the mean pain intensity in the melatonin group was significantly lower than the third group (P<0.05). Conclusion: injection preventive melatonin is more effective than pregabalin to reduce pain throughout the first 24 hrs after the TAH. [ABSTRACT FROM AUTHOR]

Background: Digestive endoscopy (DE) is uncomfortable for most patients. Lorazepam is a potent benzodiazepine with anxiolytic and sedative effects. Objective: This study aims to determine the sedative effect of sublingual lorazepam versus placebo as a premedication in patients who underwent DE. Design: This is a mono-center, double-blind, and randomized controlled trial. Methods: A lorazepam sublingual tablet was made by researchers and physical tests were done on it, then the double-blind placebo-controlled trial was done to investigate the efficacy of 2 mg sublingually administered lorazepam as a premedication for endoscopy. Lorazepam or a placebo tablet was administered sublingually 30 min before the endoscopy. The patients, nurses, and physicians were blinded to the patient group. The depth of sedation was evaluated according to the American Society of Anesthesiology. Results: In all, 116 patients were randomly assigned to take either lorazepam (n = 58) or a placebo (n = 58). The results of physical properties tests were acceptable according to United States Pharmacopeia. There were no statistical differences between groups regarding age and gender. In the lorazepam group, 75.8% of patients showed mild sedation, and 24.2% of patients showed no sedation. All of the patients in the placebo had no sedation (p = 0.001). Time of procedure (p < 0.001), intraoperative O2 saturation (p < 0.001), intraoperative heart rate (p < 0.001), and intraoperative blood pressure (p < 0.001) were significantly lower in the lorazepam group. No significant or dangerous side effects were observed except a bit of giddiness and dizziness. Conclusion: The results of this study showed that prescription of sublingual lorazepam 25–30 min before endoscopy provided mild sedation. Registration: IRCT201611039014N130 (05/11/2016); https://en.irct.ir/trial/9568. [ABSTRACT FROM AUTHOR]

Background: We aimed to evaluate whether a single dose of ketamine or dexmedetomidine before induction of general anesthesia could reduce the incidence of postoperative delirium (primary outcome) or cognitive dysfunction (secondary outcome) in elderly patients undergoing emergency surgery. Patients and methods: This randomized, double-blinded, placebo-controlled trial included 60 elderly patients who were scheduled for emergency surgery. The patients were randomly assigned into one of three groups (n = 20): group I received 0.9% normal saline, group II received 1 µg/kg dexmedetomidine, and group III received 1 mg/kg ketamine right before anesthesia induction. Patients were observed for three days after surgery and tested for postoperative delirium and cognitive dysfunction using the delirium observation screening scale and the mini-mental state examination score, respectively. Results: The dexmedetomidine group had the lowest incidence of delirium (p = 0.001) and cognitive dysfunction (p = 0.006) compared to the ketamine and placebo groups. The multivariate logistic regression model revealed that dexmedetomidine reduced the incidence of postoperative delirium by 32% compared to placebo (reference) (OR = 0.684, 95% CI: 0.240–0.971, p = 0.025), whereas ketamine increased the risk by threefold (OR = 3.012, 95% CI: 1.185–9.681, p = 0.013). Furthermore, dexmedetomidine reduced the incidence of postoperative cognitive dysfunction by 62% (OR = 0.375, 95% CI: 0.091–0.543, p = 0.012), whereas ketamine increased the risk by 4.5 times (OR = 4.501, 95% CI: 1.161–8.817, p = 0.006). Conclusion: A single pre-anesthetic bolus of dexmedetomidine is a practical choice for preventing postoperative delirium in elderly patients undergoing emergency surgery. Trial registration: This study was approved by the Ethics Committee of Aswan University Hospital (approval number: aswu/548/7/2021; registration date: 06/07/2021) and registered on ClinicalTrials.gov (NCT05341154) (22/04/2022). [ABSTRACT FROM AUTHOR]

An interview with The University of Texas MD Anderson Cancer Centers' Doctor Neil D. Gross is presented. He talks about updates on the use of neoadjuvant cemplimab in treating patients with resectable stage II to stage IV cutaneous squamous cell carcinoma (CSCC). He discusses the results of the clinical trial on the treatment. He cites how the treatment affected the quality of life of the patients.

Background: Laparoscopic cholecystectomy is a proper treatment for cholecystitis but the Carbon dioxide gas which is used in surgery stimulates the sympathetic system and causes hemodynamic changes and postoperative shivering in patients undergoing operations. This study was conducted to evaluate the effects of clonidine on reducing hemodynamic changes during tracheal intubation and Carbon dioxide gas insufflation and postoperative shivering in patients undergoing laparoscopic cholecystectomy. Material and Methods: This prospective, randomized, triple-blind clinical trial was conducted on 60 patients between the 18-70 years-old age group, who were candidates of laparoscopic cholecystectomy surgery. The patients randomized into two groups (30 patients received 150 µg oral clonidine) and 30 patients received 100 mg oral Vitamin C). Heart rate and mean arterial pressure of patients were recorded before anesthesia, before and after laryngoscopy, before and after Carbon dioxide gas insufflation. Data were analyzed using Chi-2, student t-test, and analysis of variance by repeated measure considering at a significant level less than 0.05. Results: The findings of this study showed that both heart rate and mean arterial pressure in clonidine group after tracheal intubation and Carbon dioxide gas insufflation were lower than patients in the placebo group, but there was not any statistically significant difference between the two groups (p>0.05) and also postoperative shivering was not different in groups. There was no significant statistical difference in postoperative shivering between the two groups (p>0.05). Conclusion: Using 150 µg oral clonidine as a cheap and affordable premedication in patients undergoing laparoscopic cholecystectomy improves hemodynamic stability during operation. [ABSTRACT FROM AUTHOR]

Background: Antimicrobial resistance (AMR) is one of the key challenges in healthcare, and effective antimicrobial stewardship programs (ASPs) can play a vital role to control it. The aim of the current study was to assess the impact of the Lean Six Sigma (LSS) methodology on a hospital-wide ASP. Methods: This retrospective descriptive study was conducted at Mediclinic Welcare Hospital (MWEL), Dubai, the United Arab Emirates (UAE). The critical-to-quality (CTQs) data were collected pre/post interventions, including leadership support, guideline implementation, and audits. The study focused on inpatients who received antimicrobials from January 2021 to July 2022, analyzing ASP metrics (utilization, processes, and outcome measures). Results: The ASP improvements led to an 81.7% decrease in hospital's parenteral antimicrobial expenses from January 2021 to July 2022, and a 54.2% reduction in antimicrobial usage while maintaining clinical outcomes. The average defined daily dose per 100 bed-days drop of 12.5% further demonstrated this positive trend. The intervention was not accompanied by higher nosocomial infection rates, longer stays, or mortality. Additionally, intervention led to better compliance with surgical prophylaxis bundles, antimicrobial protocols, hand hygiene and other ASP CTQ metrics. Conclusions and recommendations: This study emphasized the significance of implementing the LSS methodology in addressing process variations, enhancing ASP outcomes, and reducing antimicrobial use. These findings can inform health policymakers to improve future ASP outcomes. Additionally, sustainability through continuous monitoring and ongoing education initiatives should be considered to ensure the long-term success of these improvements. [ABSTRACT FROM AUTHOR]

Background: Multiple myeloma (MM) management includes primary chemotherapy, followed by autologous bone marrow transplantation (ABMT) if the bone marrow gets cleared of cancerous cells. In some cases disease relapse may occur if complete clearance is not achieved. Transplantation was primarily performed through the bone marrow; however, peripheral blood has become more favored due to its safety and convenient collection in case of appropriate bone marrow mobilization which is a challenging issue. Objectives: The current study was aimed to investigate the effectiveness of desipramine application for bone marrow mobilization in multiple myeloma (MM) who were candidate for autologous bone marrow transplantation (ABMT). Methods: The current randomized clinical trial involved l22 MM patients who were candidate for ABMT. The participants were divided into two intervention groups: the first group (n = 63) received G-CSFonlytreatment, while the second group (n = 59) received a similar G-CSF treatment plus desipramine. The first group received 30 microgram intravenous G-CSF for five days and the second one was treated with G-CSF with similar pattern in combination with daily 100 mg desipramine initiated within three days before G-CSF treatment and continued until the last dose of G-CSF. CD34+ cells and complete blood cells and differentiation were assessed bythe end of the interventions. Results: The findings of the study show that the number of CD34+ cells, white blood cells (WBC) and platelet (PLT) count were remarkably higher among the patients receiving the combination therapy compared to the G-CSF only treated group (P-value < 0.001) within 5 days after the interventions; however, no significant differences were observed between the two groups when considering the stage of the disease and the frequency of chemotherapy sessions (P-value > 0.05). Conclusions: Desipramine application led to significantly increased levels of CD34+ cells as the representatives of bone marrow mobilization. Besides, the patients treated with this regimen had higher serum levels of WBC and PLT; however, the disease stage and the number of chemotherapy sessions did not affect the response to the treatment. [ABSTRACT FROM AUTHOR]

Introduction: Daratumumab is a humanized IgG1 kappa monoclonal antibody directed against CD38 used to treat myeloma. The recommended dose of daratumumab is 16 mg/kg, with no lower or upper threshold. Here, we present the first split-dose daratumumab infusion experience in a myeloma patient with morbid obesity in whom daratumumab was interrupted because of grade 3 infusion-related reaction. Case report: A female myeloma patient with morbid obesity received a combination of chemotherapy with daratumumab because of disease relapse. The calculated dose for the first intravenous daratumumab infusion was 1840 mg/day based on the weight of the patient, which was measured as 115 kilograms. Daratumumab infusion was initiated as appropriate but needed to be stopped because of a severe sudden presentation of shortness of breath and hypoxemia. Management and outcome: After daratumumab was stopped, premedication was repeated, and oxygen, intravenous and inhaler steroids, inhaler β2 agonists and intravenous diphenhydramine were given in repeated doses. She was monitored and followed up in the emergency critical care unit. Daratumumab treatment with a split-dose schedule was planned after she fully recovered from all signs and symptoms. The total dose was divided into two doses and was given without any complications on two consecutive days. After that, she was also able to tolerate once a week 1840 mg of daratumumab in a single day. Discussion: There is a paucity of data regarding the best practice for instituting intravenous daratumumab in patients with morbid obesity regarding the infusion rate and duration, optimal dosing, and ideal way to cope with infusion-related reactions. Our case suggests a potential role for a split-dose schedule for patients with obesity and potential dose reductions and infusion-related reactions. [ABSTRACT FROM AUTHOR]

Background: Emergence agitation (EA) is a prevalent complication in children following general anesthesia. Several studies have assessed the relationship between melatonin or its analogs and the incidence of pediatric EA, yielding conflicting results. This meta-analysis aims to assess the effects of premedication with melatonin or its analogs on preventing EA in children after general anesthesia. Methods: PubMed, EMBASE, the Cochrane Library, ProQuest Dissertations & Theses Global, Web of Science, CNKI, Wanfang Data, clinicaltrials.gov, and WHO International Clinical Trials Registry Platform were searched until 25 November 2022. We included randomized controlled trials that assessed EA in patients less than 18 years old who underwent general anesthesia. We excluded studies that did not use a specific evaluation to assess EA. Results: Nine studies (951 participants) were included in this systematic review. Melatonin significantly reduced the incidence of EA compared with placebos (risk ratio 0.40, 95% CI 0.26 to 0.61, P < 0.01) and midazolam (risk ratio 0.48, 95% CI 0.32 to 0.73, P < 0.01). Dexmedetomidine remarkably decreased the incidence of EA compared with melatonin (risk ratio 2.04, 95% CI 1.11 to 3.73, P = 0.02). Conclusions: Melatonin premedication significantly decreases the incidence of EA compared with placebos and midazolam. Dexmedetomidine premedication has a stronger effect than melatonin in preventing EA. Nevertheless, further studies are warranted to reinforce and validate the conclusion on the efficacy of melatonin premedication in mitigating EA in pediatric patients. [ABSTRACT FROM AUTHOR]

Background: Preoperative anxiety (PA) in children is a common phenomenon associated with various negative patient outcomes. Allaying PA is accepted as a standard of care, but its use is not universal and often overlooked. This survey is designed to evaluate the nationwide current practice patterns and attitudes of anesthesiologists toward the practice of allaying PA in children. Materials and Methods: A questionnaire of 25 questions, including information on methods of relieving PA in children, reasons for noncompliance, and associated complications, was framed. It was circulated among members of the Indian Society of Anaesthesiologists through an online survey of Google Forms and manually. Results: Four hundred and fifty anesthesiologists were surveyed. Responses were predominantly from anesthesiologists practicing in medical colleges across the country. Although 97% of the surveyed respondents practiced anxiety-relieving strategies, only 37% used it consistently. Seventy-three percent of anesthesiologists practiced both pharmacological and nonpharmacological techniques. The most common reason for avoiding premedication was an anticipated difficult airway (88%). Inadequate sedation was a commonly reported problem. Ninety-five percent of participants felt that PA-relieving strategies should be integral to pediatric anesthesia practice. The most common reason for not following these practices was an inadequate hospital infrastructure (67%). Ninety-seven percent of the participants believed that more awareness is required on this crucial perioperative issue. Conclusion: Only 37% of the surveyed anesthesiologists consistently used some form of PA-relieving strategy and the practice varied widely. Further improvement and team approach involving anesthesiologists, surgeons, and nurses is required to ensure the quality of pediatric PA-relieving services and establish it as a standard of care. [ABSTRACT FROM AUTHOR]

Background: Elective surgery cancellations and delays are associated with negative financial and staffing ramifications, adverse clinical outcomes, and poor patient outcomes. The Princess Alexandra Hospital in Brisbane, Australia, performs approximately 15 000 elective surgeries per year and medication optimisation is pivotal in preparing a patient for surgery to avoid same day of surgery theatre cancellations. Ideally, patients are seen in a multidisciplinary pre‐admission clinic for optimisation of their health and medicines, and to provide education regarding their surgery. Aim: To calculate the incidence of elective surgery cancellations due to medication misadventure over a 12‐month period. Method: A retrospective audit at a tertiary Queensland Hospital was conducted over a 12‐month period (April 2021–March 2022), including patients who had their elective surgeries cancelled. The medical records from the hospital's digital databases for patients who were identified by the hospital coding service as 'unfit for surgery' were screened to see if the reason for the surgery cancellation was due to medication misadventure. The project was reviewed by the Metro South Human Research Ethics Committee and deemed exempt from further review (Ref No: CM20221651). Results: The surgery cancellation rate was 50% (n = 6626 cancelled surgeries from 13 255 total surgeries booked). The same day of surgery cancellation rate was 5.5% (n = 734). Medication misadventure resulting from suboptimal medicine management was responsible for 1% (n = 66 out of 6626 surgery cancellations). A total of 41% (n = 27) of patients had their surgery cancelled ahead of time by the pharmacist due to a medication not being withheld for long enough, which prevented a same‐day cancellation. Conclusion: Having a pre‐admission clinic pharmacist improves preoperative medication optimisation and has been proven to avoid same‐day cancellations. [ABSTRACT FROM AUTHOR]

Purpose: An international shortage of ranitidine led to adjustments in premedication regimens for paclitaxel-based chemotherapy in early October 2019. In this study, we implemented and evaluated an anti-allergic protocol without histamine-2 antagonists (H2As) and aimed to assess the risk of hypersensitivity reactions (HSRs) to the different premedication regimens used. Methods: We conducted a single-center observational retrospective study of paclitaxel administrations (7173 administrations in 831 patients). Between January 2019 and December 2020, all allergies reported were recorded. A mixed logistic regression model was implemented to predict the risk of allergy at each injection and to account for repeated administration per patient. Results: A total of 27 HSRs occurred in 24 patients. No protective effect was observed for H2A when comparing paclitaxel injections with H2A premedication versus without H2A (OR = 1.12, p = 0.84). There was also no significant difference in risk of HSR for famotidine versus ranitidine (OR = 0.79, p = 0.78). However, the risk of HSRs was significantly lower for paclitaxel injections with corticosteroids than for those without (OR = 0.08, p = 0.03). In addition, the risk of HSR was significantly higher for the first, second, or third paclitaxel injections than for the subsequent injections (OR = 10.1, p < 0.001). Conclusion: We did not find substantial evidence of an increased risk of HSR due to the absence of H2A in the premedication protocols for paclitaxel. Thus, in contrary to the existing literature on paclitaxel, our findings support the use of a premedication protocol without H2A. [ABSTRACT FROM AUTHOR]

Surgery for Crohn's disease (CD) is not curative, as postoperative recurrence (POR) after ileocolonic resection is the rule in the absence of prophylactic treatment. In the present article, we critically review available data on the role of anti-tumour necrosis factor (TNF) agents and new biologics (including vedolizumab and ustekinumab) in the prevention and treatment of POR after surgery in CD. Several studies (summarised in various meta-analyses) have confirmed the efficacy of anti-TNFs in the prevention of POR. We identified 37 studies, including 1863 CD patients, with mean endoscopic POR at 6–12 months of 29%. Only few randomised controlled trials (RCTs) have directly compared thiopurines and anti-TNFs, with controversial results, although the superiority of the latter is supported by several meta-analyses. Infliximab and adalimumab seem equally effective. The combination of anti-TNFs and immunosuppressives should be considered in patients previously exposed to anti-TNFs. Several studies have shown that anti-TNFs remain an effective option to prevent POR also in patients with anti-TNF failure before surgery. In fact, the use of the same anti-TNF before and after surgery might be effective for the prevention of POR. Prophylactic anti-TNF treatment, once started, should be continued long term. Anti-TNFs are also effective for the treatment of established POR. Retreatment with anti-TNFs for POR is a valid strategy even after their preoperative failure. In six studies (including 156 patients) evaluating vedolizumab, mean endoscopic POR at 6–12 months was 41%. The non-randomised comparison of anti-TNFs and vedolizumab has provided controversial results. One placebo-controlled RCT confirmed that vedolizumab is quite effective in preventing POR in CD patients with increased risk of recurrence. Seven studies (including 162 patients) evaluated ustekinumab, with a mean endoscopic POR at 6–12 months of 41%. The comparative efficacy of ustekinumab and anti-TNFs is still unclear. Ustekinumab and vedolizumab seem to be equally effective, although the experience is very limited. In conclusion, to date, anti-TNFs are the most effective agents in preventing and treating POR in CD. Anti-TNFs remain an effective option to prevent POR also in patients with anti-TNF failure before surgery. Vedolizumab seems to be quite effective in the prevention of POR in patients with increased risk of recurrence. Ustekinumab is probably also effective in the postoperative setting, although the comparative efficacy with anti-TNFs or vedolizumab is still unclear. [ABSTRACT FROM AUTHOR]

Objective: Postoperative pain at buccal mucosal graft (BMG) harvest site hinders the resumption of food intake. We aim to study the effect of inferior-alveolar nerve block plus buccal nerve block (IANB + BNB) on pain scores. Methods: This was a retrospective case--control study performed in a single center from July 2021 to July 2022 (ethics committee approval: T/IM- NF/Ur ology /23/2 7). We performed IANB + BNB with a mixture of 5 mL each of 1% lignocaine and 0.25% bupivacaine and 4 mg dexamethasone, in addition to local infiltration of 2% lignocaine and (1:100 000) epinephrine combination before harvesting BMG. We retrospectively compared the recorded postoperative pain scores using the visual analog scale (VAS) among patients who received and did not receive IANB + BNB. The time for resumption of pain-free diets and postoperative analgesic requirements was compared. Results: The study groups included 20 patients each and were similar in age and graft size. The VAS scores at 0 hours [1.0 (1.25) vs. 2.5 (3.5); P= .043], 6 hours [2.40 (± 0.69) vs. 4.60 (± 0.97); P= .008], 12 hours [2.50 (± 0.97) vs. 4.80 (± 0.92); P= .008], and 24 hours [3.0 (1.25) vs. 4.5 (1.25); P= .002] were better in the intervention arm. However, the pain beyond the second day was similar. The IANB + BNB group resumed solid food quicker, and the cumulative paracetamol dose required was less [8.9 (± 3.03) vs. 16.2 (± 5.06) g; P= .001]. Fewer patients required opioids. Conclusion: Patients who received IANB + BNB had better pain scores during the first 24 hours following surgery and tolerated solid diet quicker. [ABSTRACT FROM AUTHOR]

Introduction: Hemodynamic disturbance is a common problem in patients undergoing thyroid surgery. It may be due to episodic increases in thyroid hormones (thyroid storm) or stimulation of the carotid sinus baroreflex. The aim of the present study was to investigate effectiveness of the pre-operative oral Clonidine on reducing these hemodynamic changes during total thyroidectomy surgery. Methods: In a prospective, randomized, double-blind study, 80 patients scheduled for elective total thyroidectomy were randomized to receive either 0.2 mg Clonidine (n=40) or a matched placebo (n=40) orally sixty minutes before entering the operating room. Hemodynamic variables, the duration of surgery, estimated amount of blood loss and the dose of administered remifentanil were recorded for further analysis. Results: Oral Clonidine was found to be significantly better in maintaining stable hemodynamics compared to the control group. Also, In the Clonidine group, the estimated amount of blood loss (110.4±10 ml vs. 182.2±11.4 mL, P =0.04), duration of the surgery (78.26±55.2 min vs. 105.16±61.75 min, P =0.027) and administered dose of remifentanil (26.67±6.6 μg vs. 216.2±14.8 μg, P =0.01) were also significantly lower than the control group. Conclusion: Pre-operative administration of 0.2 mg oral Clonidine in patients undergoing total thyroidectomy results in improved perioperative hemodynamic stability and reduced response to perioperative stress. [ABSTRACT FROM AUTHOR]

Background We hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT). Methods We used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours. Results We included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short. Conclusions We found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials. Trial registration number URL: https://www. clinicaltrials.gov ; Unique identifier: NCT03192332 [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess the association between treatment characteristics of prostaglandin E1 including initiation time and duration, maximal and cumulative doses, and adverse effects. Design: A retrospective cohort study in which medical records of neonates with duct-dependent lesions were studied for treatment parameters and adverse effects. Multivariable logistic regression model was applied for testing the effect PGE1 variables on outcomes. Main outcome measures: The primary outcomes of this study were association of adverse effects of PGE1 treatment with maximal dose, cumulative dose, and treatment duration. The secondary outcomes included safety of feeding in infants treated with PGE1. Results: Eighty-two infants with duct-dependent lesions receiving PGE1 were included. Several infants who received early PGE1 treatment required ventilation support. Feeds were ceased more often as the cumulative dose and duration of PGE1 treatment increased. Gastrointestinal adverse effects were significantly associated with the cumulative dose of PGE1 and treatment duration. Apneas, hyperthermia, and tachycardia were associated with maximal dose. Our data did not demonstrate a difference in the incidence of NEC associated with characteristics of PGE1 treatment. Conclusion: Cumulative PGE1 dose is associated with gastrointestinal adverse effects in neonates. Lower doses should be considered in neonates expecting prolonged PGE1 treatment. [ABSTRACT FROM AUTHOR]