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Background: Intranasal drug delivery shows potential for brain access via olfactory and trigeminal routes. Purpose: This work aimed to ensure brain availability of nalbuphine via the nasal route. Method: Chitosan based nanoparticles loaded with nalbuphine were successfully prepared using ionic gelation method and characterised. Result: SEM results revealed that the nanoparticles were spherical in shape, with an average size of 192.4 ± 11.6 nm. Zeta potential and entrapment efficiency was found 32.8 mV and 88.43 ± 7.75%, respectively. The X-ray diffractometry and DSC results unravel a profound understanding on the physical and thermal characteristics. The in-vitro release of nalbuphine from the nanoparticles was biphasic, with an initial burst release followed by a slow-release profile. In-vitro cell study on HEK-293 cells and microscopic images of brain tissue confirmed the safety profile of formulation. In-vivo efficacy studies on animal confirmed the effectiveness of developed intranasal formulation as compared to the standard therapy. The in-vivo pharmacokinetic studies showed that the prepared nanoparticles were able to efficiently deliver nalbuphine to the brain in comparison to the other body organs. Gamma scintigraphy images showed retention of the drug in the brain. Furthermore, the efficacy studies confirmed that the nanoparticles were found significantly more effective than the marketed formulation in pain management. [ABSTRACT FROM AUTHOR]

This study aimed to assess the incidence of post‐discharge nausea and vomiting (PDNV) following sedation with nalbuphine and etomidate and to evaluate the prophylactic effects of scopolamine in reducing PDNV. A two‐stage prospective clinical trial was conducted. The first part involved an observational study of 77 subjects to assess the PDNV incidence post‐sedation with nalbuphine, etomidate, and propofol. The second part compared the effectiveness of palonosetron 0.075 mg (P group), scopolamine 0.1 mg (S group), and their combination (PS group) in reducing PDNV. The primary endpoint was the incidence of PDNV within 8 h post‐sedation. Secondary outcomes included PDNV frequency and severity at 8–24, 0–24, and 24–48 h and side effects of medications. The incidence of PDNV within 8 h post‐sedation was 37.66% (29/77). The PS group showed a significantly lower PDNV rate of 2.56% within 8 h, compared to the P group (35.71%, P <.001), S group (19.64%, P <.001), and control group (38.39%, P <.001), respectively. The S group (19.64%) also had a lower rate than the P group (35.71%, P =.007) and the control group (38.39%, P =.002). Subgroup analysis suggested a potential differential effect of palonosetron in reducing vomiting among male patients undergoing gastrointestinal procedures. The combination therapy was also associated with fewer cases of mild or no nausea and vomiting. In summary, the incidence of PDNV following sedation with nalbuphine and etomidate was notably high. The combination of scopolamine and palonosetron was more effective in preventing PDNV, with implications for improved post‐sedation care. [ABSTRACT FROM AUTHOR]

To evaluate the physical compatibility and chemical stability of the combination of bupivacaine, epinephrine, and nalbuphine when in mixed in 0.45 % sodium chloride, 0.9 % sodium chloride, or Plasma-Lyte A. Bupivacaine 0.5 % (15 mL), epinephrine 1 mg/mL (0.15 mL), and nalbuphine 10 mg/mL (0.5 mL) were combined to prepare three distinct admixtures with 0.45 % sodium chloride, 0.9 % sodium chloride, or Plasma-Lyte A. Visual inspection, spectrophotometric analysis, pH evaluation, and high-performance liquid chromatography tests were conducted at hours 0, 1, 5, 8, and 24. Samples were stored in ambient room light at room temperature. There were no demonstrable changes identified in any of the samples with regards to visual changes, spectrophotometric absorbance, or pH. In each studied fluid, the remaining drug concentrations were an average of 100.92 % bupivacaine, 95.8 % epinephrine, and 100.02 % nalbuphine. The combination of bupivacaine, epinephrine, and nalbuphine was found to be physically compatibility and chemically stable for a period of 24 h at room temperature. [ABSTRACT FROM AUTHOR]

Background: This study was designed to compare the effect of nalbuphine versus dexmedetomidine on the incidence of post-operative emergence agitation (EA) in pediatric patients undergoing elective lower abdominal surgical procedures during anesthesia with sevoflurane. Methods: A prospective, controlled trial of 135 children aged 3–6 years scheduled for elective lower abdominal surgery was randomly assigned to one of the three equal groups receiving either nalbuphine 0.1 mg/kg IV (Group N), dexmedetomidine 0.5 mic/kg IV in (Group D) or a saline solution (Group C) at 10 min before the end of surgery in a double-blind manner. Post-operative EA was assessed with pediatric anesthesia emergence delirium (PAED) scale. Results: The incidence of EA was significantly low in children in Group N and Group D compared to placebo group (p = 0.011) with no significant difference between Group N and Group D. The number of patients receiving nalbuphine and post-operative nalbuphine consumption during PACU stay were significantly higher in Group C than in Groups N and D (p = 0.024 and 0.001 respectively) with no significant differences between Group N and Group D. There was no significant difference regarding pain between the three groups at 5, 10, 20 and 30 min postoperatively. No significant difference among groups regarding the time to Aldrete score. The overall incidence of vomiting in our study was similar in the three groups. Conclusion: Nalbuphine 0.1 mg/kg was comparable to dexmedetomidine 0.5 mic/kg for decreasing the incidence and severity of EA in the PACU in sevoflurane-anesthetized children when administered intravenously 10 min before the end of surgery. Trial registration: This study was registered at ClinicalTrials.gov NCT05273671 (10/03/2022). [ABSTRACT FROM AUTHOR]

The purpose of this study was to evaluate the pharmacokinetics (PK) of intravenously (IV) and subcutaneously (SC) administered nalbuphine in domestic goats. Nalbuphine hydrochloride was administered at 0.8 mg/kg for both IV and SC routes in six goats with a minimum of 10‐day washout period between sample collection phases. Eighteen plasma samples were collected over a 36‐hour period, analyzed using reverse phase high‐performance liquid chromatography (HPLC). Plasma data were analyzed using compartmental and noncompartmental approaches. Following IV nalbuphine administration, elimination half‐life, area under the plasma concentration time curve from time 0 to infinity (AUC0 − ∞), concentration at time zero (C0), and total body clearance were 120.4 ± 39.1 (min−1 ± SD), 17311.01 ± 7227.32 (min·ng·mL−1 ± SD), 675.6 ± 337.13 (ng·mL−1 ± SD), and 44.5 ± 13.8 (mL·min−1·kg−1 ± SD), respectively. After SC nalbuphine administration, elimination half‐life, area under the plasma concentration time curve from time 0 to infinity (AUC0 − ∞), and maximum plasma drug concentration were 129 ± 52.9 (min−1 ± SD), 20826.5 ± 14376.2 (min·ng·mL−1), and 368.03 ± 503.78 (ng·mL−1). Calculated bioavailability for the SC route was 138 ± 126 (% ± SD). Nalbuphine in goats is characterized by rapid elimination and high subcutaneous bioavailability and may be a safe analgesic opioid option in goats in the future. [ABSTRACT FROM AUTHOR]

Safe and effective chemical immobilization is a necessary component of large carnivore management and research, but laws regulating controlled substances can limit the use of many drugs by non‐veterinary personnel. NalMed‐A (40 mg/mL nalbuphine HCl, 10 mg/mL medetomidine HCl, 10 mg/mL azaperone tartrate) is a non‐controlled drug combination used to immobilize a number of free‐ranging species, but there are limited published reports of its usage by non‐veterinary personnel when immobilizing American black bears (Ursus americanus) and mountain lions (Puma concolor). Additionally, there are some safety concerns regarding anecdotal reports of spontaneous arousals occurring in large carnivores immobilized with NalMed‐A. We performed a retrospective analysis of capture forms for free‐ranging black bears (n = 34) and mountain lions (n = 7) immobilized with NalMed‐A by non‐veterinary personnel across Wyoming, USA, in 2017 and 2019–2024. Induction (x̅ ± SE) was 10.74 ± 1.16 minutes for black bears (n = 34) and 7.14 ± 1.60 for mountain lions (n = 7). Reversal was 14.21 ± 1.51 minutes for black bears (n = 28) and 10.00 ± 1.26 minutes for mountain lions (n = 5). We used non‐parametric tests (Kruskal‐Wallis, Wilcoxon rank sum) and odds ratios to examine the effect of certain parameters on induction times, redoses, and spontaneous arousals in black bears. Median induction time for black bears injected in their hind leg or rump was greater than for black bears injected in their shoulder (n = 34, W = 79.5, P = 0.045). Six black bears (18%) experienced spontaneous arousals. We recommend avoiding the hind leg and rump for dart placement in bears, and using hobbles and a muzzle for large carnivores when using NalMed‐A in a free‐ranging setting because of the risk of spontaneous arousals. [ABSTRACT FROM AUTHOR]

Jin Zhang,&ast; Fan Zhang,&ast; Hao Zhang, Lei Yu, Jun Chen, Shaolin Wang Department of Anesthesiology, the Second People’s Hospital of Wuhu, Wuhu, Anhui, 241000, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Shaolin Wang, Department of Anesthesiology, the Second People’s Hospital of Wuhu, NO. 6 Duchun Road, Jinghu District, Wuhu, Anhui, 241000, People’s Republic of China, Email wuhuwsl@163.comBackground: The erector spinae plane block (ESPB) has been increasingly utilized for postoperative analgesia in thoracic, abdominal, and spinal surgeries. This study evaluated the postoperative analgesic outcomes of ESPB with nalbuphine as a ropivacaine adjuvant for lumbar trauma surgery.Methods: This randomized double-blind clinical trial included 57 participants who underwent lumbar trauma surgery. Ultrasound-guided ESPB was performed with 0.375% ropivacaine (Group R) and 0.375% ropivacaine combined with 10 mg nalbuphine (Group N); 20 mL was used per side. The primary outcome measure was the time to first postoperative remedial analgesia. The secondary outcome measures included the Numerical Rating Scale (NRS) scores at rest and during movement, cumulative sufentanil consumption after surgery, intraoperative dosage of remifentanil and sufentanil, time to first off-bed, time to first flatus, and length of hospital stay.Results: The mean difference in the time to first postoperative remedial analgesia (Group N vs Group R, 489± 52 min vs 391± 23 min) was 98 min (95% CI, 76 to 119). Kaplan–Meier survival analysis revealed an increasing pain-free population in Group N and an increasing pain-free duration. The log-rank (Mantel–Cox) test showed that the hazard ratio (HR, Group N/Group R) was 0.225 (95% CI, 0.114 to 0.443). Group N showed decreased sufentanil consumption compared with Group R at 4– 8 h, 8– 12 h and 0– 24 h after surgery (P< 0.001).Conclusion: ESPB with nalbuphine in combination with ropivacaine significantly prolonged the duration of analgesia and reduced postoperative analgesic demands compared to ropivacaine alone.Keywords: analgesia, nerve block, nalbuphine, ropivacaine, ultrasound interventional

Background This study was designed to compare the effect of nalbuphine versus dexmedetomidine on the incidence of post-operative emergence agitation (EA) in pediatric patients undergoing elective lower abdominal surgical procedures during anesthesia with sevoflurane.Methods A prospective, controlled trial of 135 children aged 3–6 years scheduled for elective lower abdominal surgery was randomly assigned to one of the three equal groups receiving either nalbuphine 0.1 mg/kg IV (Group N), dexmedetomidine 0.5 mic/kg IV in (Group D) or a saline solution (Group C) at 10 min before the end of surgery in a double-blind manner. Post-operative EA was assessed with pediatric anesthesia emergence delirium (PAED) scale.Results The incidence of EA was significantly low in children in Group N and Group D compared to placebo group (p = 0.011) with no significant difference between Group N and Group D. The number of patients receiving nalbuphine and post-operative nalbuphine consumption during PACU stay were significantly higher in Group C than in Groups N and D (p = 0.024 and 0.001 respectively) with no significant differences between Group N and Group D. There was no significant difference regarding pain between the three groups at 5, 10, 20 and 30 min postoperatively. No significant difference among groups regarding the time to Aldrete score. The overall incidence of vomiting in our study was similar in the three groups.Conclusion Nalbuphine 0.1 mg/kg was comparable to dexmedetomidine 0.5 mic/kg for decreasing the incidence and severity of EA in the PACU in sevoflurane-anesthetized children when administered intravenously 10 min before the end of surgery.Trial registration This study was registered at ClinicalTrials.gov NCT05273671 (10/03/2022).

Objective To investigate the efficacy and safety of nalbuphine for dural puncture epidural labor analgesia. Methods A total of 319 primiparous women with a full-term single fetus who received trial of labor were enrolled, and according to the drug used for analgesia, they were divided into sufentanil group (group A with 160 women) and nalbuphine group (group B with 159 women). The women in both groups were given dural puncture epidural labor analgesia, during which 3 mL of 1.5% lidocaine was injected after epidural catheter placement, and then the women in group A were given injection of 0.5 mg/L sufentanil combined with 1 mg/L ropivacaine, while those in group B were given injection of 0.3 g/L nalbuphine combined with 1 mg/L ropi-vacaine, with an initial volume of 6-15 mL. After 30 minutes, an electronic analgesia pump was connected for both groups, and sufentanil and nalbuphine were used for patient-controlled epidural analgesia, respectively. The following indicators were collected and observed: Onset time of analgesia, time of first patient-controlled analgesia (PCA) pressing, number of effective PCA pres-sings, and amount of ropivacaine used; Visual Analogue Scale (VAS) score and Ramsay sedation score before analgesia (T0), at 30 minutes after analgesia (T1), at the time of uterine opening (T2), and during labor (T3); incidence rates of adverse reactions in parturients, including pyrexia, nausea and vomiting, skin pruritus, and postoperative headache; the incidence rate of fetal heart rate deceleration, the proportion of neonates with 1 min Apgar score ≤7 points, umbilical arterial blood gas analysis, and neonatal neurological and adaptive capacity scores. Results Compared with group A, group B had significant reductions in the incidence rates of vomiting and nausea, skin pruritus, fetal heart rate deceleration, and neonatal 1 min Apgar score ≤7 (χ2=4.159-5.628,P0.05). Conclusion For dural puncture epidural labor analgesia, nalbuphine has a similar analgesic effect to sufentanil in the first stage of labor, with a poorer effect in the second stage of labor, but it can reduce analgesia-related adverse reactions in parturients and has a relatively favorable safety profile in neonates.

Abstract Background The airway should be thoroughly and accurately evaluated before anesthesia induction and endotracheal intubation. Awake direct laryngoscopy (ADL) can provide rapid, accurate, and intuitive airway assessment, especially for suspected difficult airways, and sometimes eliminates the need for fiberoptic intubation in some suspicious difficult airway cases. However, an optimal regimen has not been determined. Methods In this double-blind, controlled study, prior to ADL, 60 patients scheduled for general anesthesia were randomly allocated to receive 0.75 μg/kg of dexmedetomidine (Dex group, n = 20), 0.15 mg/kg of nalbuphine (Nal group, n = 20), or a placebo (control group, n = 20) intravenously over 10 min. At the same time, all study subjects received nebulized lidocaine for 15 min. The primary outcome was patient tolerance as assessed by a 5-point ADL comfort score, while secondary outcomes included satisfaction, coughing, pain, nausea and vital signs. Results Patients undergoing ADL in the Nal group had higher tolerance scores than those in the control and Dex groups [4 (3,4) vs. 3 (2,2.75), P

Background: The airway should be thoroughly and accurately evaluated before anesthesia induction and endotracheal intubation. Awake direct laryngoscopy (ADL) can provide rapid, accurate, and intuitive airway assessment, especially for suspected difficult airways, and sometimes eliminates the need for fiberoptic intubation in some suspicious difficult airway cases. However, an optimal regimen has not been determined. Methods: In this double-blind, controlled study, prior to ADL, 60 patients scheduled for general anesthesia were randomly allocated to receive 0.75 μg/kg of dexmedetomidine (Dex group, n = 20), 0.15 mg/kg of nalbuphine (Nal group, n = 20), or a placebo (control group, n = 20) intravenously over 10 min. At the same time, all study subjects received nebulized lidocaine for 15 min. The primary outcome was patient tolerance as assessed by a 5-point ADL comfort score, while secondary outcomes included satisfaction, coughing, pain, nausea and vital signs. Results: Patients undergoing ADL in the Nal group had higher tolerance scores than those in the control and Dex groups [4 (3,4) vs. 3 (2,2.75), P < 0.017, and 4 (3,4) vs. 2 (2,2,75), P < 0.001, respectively] and higher satisfaction [7 (6,8) vs. 4 (3,5.75), P < 0.017, and 7 (6,8) vs. 5.5 (5,6), P < 0.001, respectively]. Additionally, the Nal group had significantly fewer adverse events, such as pain and nausea than the control and Dex groups. The sedation score and peripheral oxygen and saturation were significantly higher in the Nal group than in the Dex group, with no difference between the Nal and control groups (P < 0.001, P = 0.159, respectively). Conclusions: Intravenous nalbuphine in combination with lidocaine aerosol inhalation significantly improved patient tolerance and satisfaction while reducing nausea, coughing, pain, sedation, and SpO2 levels during ADL. Highlights: • Awake direct laryngoscopy (ADL) allows rapid and accurate assessment of suspicious airways prior to the induction of anesthesia. • The combination of nalbuphine and lidocaine resulted in higher tolerability, comfort, and satisfaction than dexmedetomidine combined with lidocaine or lidocaine alone during ADL. • Nalbuphine combined with lidocaine could be safer than dexmedetomidine combined with lidocaine in terms of maintaining higher SpO2 levels and reducing the risk of loss of consciousness during anesthesia. [ABSTRACT FROM AUTHOR]

Background: Laparoscopic cholecystectomy represents a minimally invasive surgical approach for the excision of a pathological gallbladder. Dexmedetomidine is commonly used in anesthesia practice as well. Nalbuphine belongs to mixed agonist-antagonist class of opioids (ĸ-agonist and µ-antagonist) with better features such as prolonged duration of analgesia while avoiding the side effects. Hence, the present study was conducted for assessing and comparing the efficacy of intraperitoneal administration of dexmedetomidine and nalbuphine as adjuncts to ropivacaine for post-operative pain relief in patient undergoing laparoscopic cholecystectomy. Materials and Methods: Present study was conducted in Department of Anaesthesiology, Maharshi Vishwamitra Autonomous State Medical College, Ghazipur, Uttar Pradesh, India. A total of 45 patients who were scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia were enrolled. The participants were randomly divided into three groups, each consisting of 10 individuals. In Group 1, patients were administered a 50 ml solution containing 49 ml of 0.25% ropivacaine combined with 1 mcg/kg of dexmedetomidine. Group 2 received a 50 ml solution comprising 49 ml of 0.25% ropivacaine along with 5 mg of nalbuphine, while Group 3 was given a 50 ml solution that included 0.25% ropivacaine and 10 mg of nalbuphine. Postoperative pain was evaluated using the Visual Analog Scale (VAS). All data were analyzed using SPSS software. Chi-square test and ANOVA test were used for evaluation of level of significance. Results: Mean age of the patients of group 1, group 2 and group 3 was 43.2 years, 40.9 years and 41.7 years respectively. Mean BMI among patients of group 1, group 2 and group 3 was 23.7 Kg/m2, 24.1 Kg/m2, and 23.9 Kg/m2 respectively. Group 2 was associated with maximum pain as assessed by VAS. Comparing the VAS among three study groups at 2 hours and 4 hours, significant results were obtained. Conclusion: The administration of 0.25% ropivacaine combined with dexmedetomidine at a dosage of 1 mcg/kg in comparison to nalbuphine yielded the most favorable outcomes in patients. [ABSTRACT FROM AUTHOR]

This study aimed to assess the effectiveness of diverse postoperative analgesic techniques in laparoscopic colorectal surgery and ascertain whether systemic administration of nalbuphine is a suitable alternative for this type of procedure. Sixty-nine patients suffering from colorectal cancer and undergoing laparoscopic surgery were randomly divided into three groups (n = 23, per group). Group R received patient-controlled epidural analgesia (PCEA) with ropivacaine. Group M received patient-controlled intravenous analgesia (PCIA) with morphine. Group N received PCIA with nalbuphine. Pain at rest (PAR), movement-evoked pain (MEP), stress hormone and any complications during the 72 hours after surgery were recorded. Additionally, chronic post-surgical pain (CPSP) at 3 months and 6 months were also recorded. There was no significant difference in PAR among the 3 groups. However, patients in Group N had a higher intensity of MEP compared to those in Group R after surgery (p < 0.05). There was no significant difference in CPSP at 6 months among the 3 groups (p > 0.05), but the incidence of CPSP at 3 months was higher in Group N (p = 0.01, as compared to Group R). The occurrences of pruritus and postoperative nausea and vomiting (PONV) were observed to be considerably greater in Group M as compared to the other two groups (p < 0.05). In conclusion, PCEA is more effective than PCIA with nalbuphine in reducing postoperative MEP and CPSP at 3 months after laparoscopic colorectal surgery. However, there was no significant difference between PCEA and PCIA with nalbuphine in reducing CPSP at 6 months. Although morphine and nalbuphine have the similar analgesic effects, morphine is associated with more side effects. Therefore, PCIA with nalbuphine might be a good option for patients who are not suitable for PCEA or have a high risk for PONV or pruritus. [ABSTRACT FROM AUTHOR]

Introduction: Shivering is a common complication during neuraxial anesthesia, leading to metabolic and cardiovascular challenges. Existing treatments vary in effectiveness, and this study compares intravenous tramadol and nalbuphine, both administered with midazolam, for shivering control. Objectives: To evaluate and compare the efficacy of IV tramadol and IV nalbuphine, alongside midazolam, in controlling post-spinal anesthesia shivering. Materials and Methods: A prospective, randomized comparative clinical study involving 100 patients undergoing various surgical procedures under spinal anesthesia. Patients were divided into two groups to receive either IV Tramadol or IV Nalbuphine with midazolam. Parameters like shivering severity, time to cessation, recurrence, and side effects were recorded and analyzed. Results: Both tramadol and nalbuphine effectively controlled shivering with comparable response times and side effect profiles. There was no significant difference in the incidence of nausea, vomiting, and sedation between the groups. Hemodynamic stability was maintained throughout the study. Conclusion: IV tramadol and IV nalbuphine, in conjunction with midazolam, are effective in controlling post-spinal anesthesia shivering, with similar efficacy and safety profiles. They provide valuable options for clinicians in managing this common anesthetic complication. Further research is encouraged for more refined application in diverse patient populations. [ABSTRACT FROM AUTHOR]

Simple Summary: Donkey welfare and pain relief are of particular importance in the veterinary field. Therefore, pain management during surgical operations in field settings is mandatory. The current study sheds light on the antinociceptive effect of a combination of dexmedetomidine and nalbuphine premedication prior to total intravenous anesthesia using ketamine-propofol in castration procedures in field conditions. Shortly after castration, the proposed combination of dexmedetomidine and nalbuphine resulted in decreased postoperative pain. In addition, the cardiac function was improved compared to using dexmedetomidine alone during anesthesia. This was demonstrated using established clinicophysiological assessments, serum biochemical markers, and behavioral pain scores for six hours post-recovery. Dexmedetomidine and nalbuphine premedication prior to total intravenous anesthesia using ketamine-propofol showed potential benefits compared to dexmedetomidine alone in providing more analgesia and managing postoperative pain in jacks undergoing castration under field conditions. This study evaluated the antinociceptive effect of dexmedetomidine-nalbuphine vs. dexmedetomidine alone in jacks undergoing field castration under total intravenous anesthesia. Jacks were premedicated with intravenous (IV) dexmedetomidine (5 µg/kg), either alone (Group D, n = 6) or in combination with 0.3 mg/kg nalbuphine (Group DN, n = 6). IV ketamine (1.5 mg/kg) and propofol (0.5 mg/kg) were used to induce general anesthesia, which was maintained by a continuous propofol (0.2 mg/kg/min) IV infusion. The quality of anesthesia, analgesia, and recovery were evaluated. A simple descriptive scale (SDS) was used to measure pain from the recovery time to 6 h later. The DN group exhibited improvements in analgesic and recovery quality and SDS of pain at 1-, 2-, and 3-h post-recovery. There was an apparent improvement in cardiac status, as evidenced by the enhanced heart rate and electrocardiogram findings compared to group D during surgery and recovery time. The DN group had a lower level of inflammatory cytokines, both during the surgery and shortly after recovery. Therefore, the dexmedetomidine-nalbuphine combination prior to IV anesthesia of ketamine and propofol in jacks undergoing field castration resulted in a stable surgical plane of anesthesia, improved antinociception, less pain postoperatively, and better cardiac stability. [ABSTRACT FROM AUTHOR]

Objective: Following recent changes to the German Narcotics Act, this article examines prehospital analgesia by paramedics using piritramide vs. nalbuphine + paracetamol. Material and methods: Prehospital analgesia administered by paramedics from the Fulda (piritramide) and Gütersloh (nalbuphine + paracetamol) emergency services was compared regarding pain intensity at the beginning and end of the mission, measured using the numeric rating scale (NRS). Additionally, an analysis of the resulting complications was carried out. Results: In this study 2429 administrations of analgesia were evaluated (nalbuphine + paracetamol: 1635, 67.3%, initial NRS: 8.0 ± 1.4, end of NRS: 3.7 ± 2.0; piritramide: 794, 32.7%, initial NRS: 8.5 ± 1.1, end of NRS: 4.5 ± 1.6). Factors influencing NRS change were initial NRS (regression coefficient, RC: 0.7075, 95% confidence interval, CI: 0.6503–0.7647, p < 0.001), treatment with nalbuphine + paracetamol (RC: 0.6048, 95% CI: 0.4396–0.7700, p < 0.001). Treatment with nalbuphine + paracetamol (n = 796 (48.7%)) compared to piritramide (n = 190 (23.9%)) increased the odds of achieving NRS < 4 (odds ratio, OR: 2.712, 95% CI: 2.227–3.303, p < 0.001). Complications occurred in n = 44 (5.5%) with piritramide and in n = 35 (2.1%) with nalbuphine + paracetamol. Risk factors for complications were analgesia with piritramide (OR: 2.699, 95% CI: 1.693–4.301, p < 0.001), female sex (OR: 2.372, 95% CI: 1.396–4.029, p = 0.0014), and age (OR: 1.013, 95% CI: 1.002–1.025, p = 0.0232). Conclusion: Compared with piritramide, prehospital analgesia with nalbuphine + paracetamol has favorable effects in terms of analgesic efficacy and complication rates and should therefore be considered in future recommendations for paramedics. [ABSTRACT FROM AUTHOR]

Nalbuphine (NAL) is a mixed κ-agonist/μ-antagonist opioid with extensive first-pass metabolism. A phase 1 open-label study was conducted to characterize the pharmacokinetics (PKs) of NAL and select metabolites following single oral doses of NAL extended-release tablets in subjects with mild, moderate, and severe hepatic impairment (Child–Pugh A, B, and C, respectively) compared to healthy matched subjects. NAL exposures were similar for subjects with mild hepatic impairment as compared to healthy subjects and nearly three-fold and eight-fold higher in subjects with moderate and severe hepatic impairment, respectively. Datasets obtained for healthy, moderate, and severe hepatic impaired groups were modeled with a mechanistic model that incorporated NAL hepatic metabolism and enterohepatic recycling of NAL and its glucuronidated metabolites. The mechanistic model includes a continuous intestinal absorption model linked to semi-physiological liver–gallbladder–compartmental PK models based on partial differential equations (termed the PDE-EHR model). In vitro studies indicated that cytochromes P450 CYP2C9 and CYP2C19 are the major CYPs involved in NAL oxidation, with glucuronidation mainly catalyzed by UGT1A8 and UGT2B7 isozymes. Complex formation and elimination kinetics of NAL and four main metabolites was well predicted by PDE-EHR. The model is expected to improve predictions of drug interactions and complex drug disposition. [ABSTRACT FROM AUTHOR]

Objective: To investigate the changes of analgesic effect, immune stress and cognitive function after preemptive analgesia with erector spinae plane block (ESPB) combined with nalbuphine in patients undergoing thoracoscopic radical resection of lung cancer. Methods: 124 patients undergoing thoracoscopic radical resection of lung cancer were divided into control group (62 cases, ESPB) and study group (62 cases, ESPB combined with nalbuphine preemptive analgesia) according to the random number table method.The changes of postoperative analgesia pump pressing times, pain score, hemodynamic index, cellular immune function index, stress response index and cognitive function score were compared between two groups. Results: The number of postoperative analgesia pump pressing in study group was less than that in control group (P＜0.05). 6 h, 12 h, 24 h and 48 h postoperative, visual analogue scale (VAS) scores of pain in study group were lower than those in control group (P＜0.05). The heart rate (HR) and mean arterial pressure (MAP) after catheterization, slicing and after extubation in study group were higher than those in control group (P＜0.05). The levels of CD3+, CD4+ and CD4+/CD8+ in study group were higher than those in control group at 24 h postoperative, CD8+, norepinephrine (NE) and epinephrine (E) in study group were lower than those in control group (P＜0.05). The scores of mini-mental state examination (MMSE) in study group were higher than those in control group at 24 h, 48 h and 7 d postoperative (P＜0.05). Conclusion: ESPB combined with nalbuphine for preemptive analgesia in patients undergoing thoracoscopic radical resection of lung cancer, which can exert good analgesic effect, stabilize hemodynamics, reduce immune stress and affect cognitive function. [ABSTRACT FROM AUTHOR]

Background & aim Paravertebral block (PVB) is a commonly used technique, for postoperative analgesia after modified radical mastectomy(MRM).Though many adjuvants to bupivacaine in PVB have been tried for postoperative analgesia, none has been found ideal. We have compared the duration of analgesia in PVB using adjuvant like dexmedetomidine and nalbuphine with bupivacaine after MRM. Methods Sixtyfive female patients posted for MRM were divided into two groups. Group BN received ultrasound guided PVB with 20 ml bupivacaine 0.25% with nalbuphine 10mg and Group BD received 20 ml bupivacaine 0.25% with dexmedetomidine 1 μg/kg. After confirming PVB, surgery was done under general anesthesia in all patients. Time for 1st rescue analgesic request was the primary aim of our study. Secondary aim of our study was numerical rating scores (NRS) for pain at rest and on movement and total analgesic consumption. Side effects like nausea and vomiting,hemodynamics and sedation in post operative 24 hrs were also assessed. Results The time of the first rescue analgesic requirement was prolonged in the group BD (7.32 ± 1.75 hours) in contrary to group BN (4.94 ± 2.12 hours). The mean total paracetamol consumption as rescue analgesia in the in the first 24 hours postoperatively was significantly reduced in group BD (2.7 ±0.94 gm) in contrary to group BN (3.6 ± 0.98 gm). (p<0.001) Decrease in hear rate and mean arterial pressure was more in BD group compared to BN group intraoperatively. (p<0.001) Conclusion Dexmedetomidine provides prolonged analgesia when used as additive to bupivacaine in PVB for modified radical mastectomy compared to nalbuphine. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to determine the most effective dose of dexmedetomidine as an adjuvant to prilocaine in spinal anesthesia. Methods: Sixty-nine adult patients (21 to 65 y) scheduled for elective surgeries under spinal anesthesia were included in the study. Patients received spinal anesthesia with 3 mL of prilocaine and 0.5 mL dexmedetomidine of dose according to randomization of 5,10 and15 µg (D5, D10 and D15 respectively). Time of the first request of analgesia was set as a primary outcome. Results: Time of the first request of rescue opioid was significantly shorter in D5 group (8 ± 6 h) compared to D15 group (21 ± 4 h) (P < 0.018). 24 h of postoperative Nalbuphine consumption was higher in D5 group (4.67 ± 0.59 mg) compared to D15 group (2.5 ± 0.71 mg) (P = 0.012). The onset of sensory and motor blocks was significantly earlier in group D15 and D10 compared to group D5. Group D15 showed a significantly prolonged duration of sensory and motor blockade than Groups D10 and D5. The duration of sensory and motor blockade was significantly prolonged in group D10 compared with group D5 (P < 0.001). Conclusion: 10 and 15 μg dexmedetomidine as an adjuvant to prilocaine in spinal anesthesia shortened the onset of both sensory and motor block, prolonged the duration of sensory block, motor block, and the time to first analgesic. [ABSTRACT FROM AUTHOR]

Background: Nalbuphine, a synthetic k-agonist and µ-antagonist, provides efficient pain relief while reducing opioid-related adverse effects. This study aims to compare the efficacy of intrathecal nalbuphine (ITN) with intrathecal morphine (ITM) for post-TKA pain. Methods: A retrospective cohort analysis of 131 patients who underwent TKA with spinal anesthesia (SA), a single shot of adductor canal block, and periarticular injections was conducted. The patients were divided into 2 groups, Group N received 0.8 mg nalbuphine, and Group M received 0.2 mg morphine as an adjuvant to SA. Propensity-score matching was employed to compare the visual analog scales (VAS) of postoperative pain intensity, cumulative morphine use (CMU), maximum knee flexion angle, straight leg raise (SLR) ability, incidence of postoperative nausea and vomiting (PONV), and length of hospital stay (LHS). Results: The mean VAS of group M were significantly lower than group N at 6, 12, 18, and 24 h (P < 0.01). Group M had lower CMU than group N at 24 h (P < 0.01) and 48 h (P < 0.01), while there was no significant difference between groups in terms of knee flexion angle and SLR at any time point. Additionally, 29.3 and 57.9% of patients in group N and M experienced PONV, respectively (p = 0.04), and group N had significantly shorter LHS compared to group M (P < 0.001). Conclusion: Although, intrathecal morphine (ITM) still provides better pain control particularly in the first 24 h, patients who received intrathecal nalbuphine (ITN) had significantly fewer incidence of PONV, and shorter LHS. [ABSTRACT FROM AUTHOR]

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Yan Li, Qi Li, Guangchao Zhao, Haopeng Zhang, Haixing Zhong, Yi Zeng Department of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi’an, 710000, People’s Republic of ChinaCorrespondence: Yi Zeng; Haixing Zhong, Department of Anesthesia and Perioperative Medicine, Xijing Hospital, the Fourth Military Medical University, Xi’an, 710000, People’s Republic of China, Tel +8613991267646 ; +8613991946615, Email zengyi1014@163.com; haixing.zhong@139.comBackground: To investigate the effects of nalbuphine on emergency agitation (EA), which affects up to 80% of the children following otolaryngology procedures, in children undergoing cochlear implantation.Methods: A prospective double-blinded randomized controlled clinical trial was conducted between November 2020 and October 2022. Eligible children, aged 6 months to 3 years old, were randomly assigned to either 0.1 mg/kg, 0.15 mg/kg, 0.2 mg/kg nalbuphine or 0.9% saline groups. EA was defined by the Pediatric Anesthesia Emergence Delirium (PAED) score ≥ 10. Extubation time, post-anesthesia care unit (PACU) length of stay, severe EA (PAED ≥ 15), peak PAED score, the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale, Ramsay sedation score, and adverse events were also recorded.Results: A total of 104 children were enrolled, with 26 children in each group. Nalbuphine significantly reduced the EA occurrence from 73.1% in the saline group to 38.5%, 30.8%, and 26.9% in the 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg nalbuphine groups, respectively (P < 0.001), without affecting the extubation time and PACU length of stay. More children (34.6%) in the 0.9% saline group experienced severe EA. Higher dose nalbuphine (0.15 mg/kg, 0.2 mg/kg) showed lower peak PAED score, better analgesia and sedation effect compared with 0.1 mg/kg nalbuphine and saline groups. However, 0.2mg/kg nalbuphine caused undesired over-sedation in two (7.7%) children. No other adverse events were reported.Conclusion: Young children undergoing cochlear implantation surgery were at a high risk of EA and postoperative pain, while 0.2 mg/kg nalbuphine might be an ideal candidate for EA and pain prevention when used under close monitoring.Trial Registration: ChiCTR2000040407.Keywords: emergence agitation, nalbuphine, cochlear implantation, postoperative pain

Background: Laryngoscopy and orotracheal intubation often trigger a hemodynamic response, increasing catecholamines and potentially leading to higher morbidity. Fentanyl, with a high safety margin and rapid onset, and Nalbuphine, a µ receptor antagonist and k receptor agonist with minimal respiratory depression and a “ceiling effect,” are commonly used to mitigate this response. Aim: This study compares the efficacy of Fentanyl and Nalbuphine in reducing the pressor response during laryngoscopy and intubation in patients under general anesthesia, monitored by Bispectral Index (BIS). It also evaluates total analgesic requirements, time to first rescue analgesic post-extubation (VAS score), and associated complications. Method: The study was a hospital-based, prospective, double-blind, randomized interventional trial registered under the Clinical Trials Registry - India (CTRI/2022/05/042731). The sample size of 70 patients (35 in each group) was calculated based on alpha error, study power, and the minimum clinically significant difference for MAP after induction. Patients aged 18-65 years with ASA grade I and II and body weight between 40-70 kg were included. Group A received Fentanyl, and Group B received Nalbuphine. Vital parameters were monitored during the surgery, and additional doses of the study drug were administered if the BIS score exceeded 60. Postoperative analgesic effect was evaluated by a blinded anesthesiologist. Results: The demographic characteristics of the study population were similar between the Fentanyl and Nalbuphine groups, as indicated by age, weight, sex, and ASA physical status, there was a statistically significant difference in systolic blood pressure, diastolic blood pressure, mean arterial pressure and heart rate post-intubation, with the Nalbuphine group demonstrating a greater increase compared to the Fentanyl group, which was significant at all time intervals.

Background: Opioid analgesics with local anesthetics in an epidural route are extremely safe, effective, and reliable methods of post-operative pain relief. Aims and Objectives: The primary objective is to compare the duration of analgesia and pain scoring by visual analog scale. The secondary objective is to monitor sedation, hemodynamic changes, and side effects such as nausea, vomiting, shivering, and pruritus. Materials and Methods: A prospective randomized comparative study of 0.2% ropivacaine with nalbuphine and 0.2% ropivacaine with fentanyl in epidural route for post-operative analgesia in elective lower limb surgeries under spinal anesthesia was carried out in a population of 80 patients. After 1½ h of surgery under spinal anesthesia, patients in group RF received 10 mL of 0.2% ropivacaine with 25 mcg of fentanyl and those in group RN received 10 mL of 0.2% ropivacaine with 2.5 mg of nalbuphine and were observed for the study parameters over time. Results: The mean duration of analgesia was longer in group RN than in group RF (398.45 vs. 222.88 min). The hemodynamic parameters such as heart rate, mean arterial pressure, and respiratory rate were statistically significant from 240 to 480 min which is 4–6 h in group RF and 6–8 h in group RN. 27.5% of patients in group RN attained sedation whereas 7.5% of subjects in group RF had a sedation score of 2 and above at 30 min. The subjects in group RN had a lower visual analog score than group RF. 12% and 4% of patients had vomiting in group RN and group RF, respectively. Conclusion: Epidural nalbuphine in a dose of 2.5 mg with 0.2% ropivacaine provided a longer duration of analgesia with better pain score and more sedation which was advantageous for post-operative patient compliance and satisfaction as compared to 25 mcg of fentanyl with 0.2% ropivacaine.