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Background: Dose-finding studies in anaesthesiology aim to target the effective dose (ED) of an anaesthetic agent in a specific population. The common dose-finding designs used are the up and down method (UDM), the biased-coin up and down (BCD), and the continual reassessment method (CRM). Although the advantages of CRM over the UDM and BCD methods have been described in the statistical literature in terms of precision and direct estimation of ED, CRM may also offer attractive properties from an ethical point of view. Methods: Based on Monte Carlo simulations, this article aims to compare the three methods with regard to 1) their ability to find as close an estimate as possible for the ED95 or ED90 and 2) the total number of patients needed to treat and the number of failures. Results: In contrast to BCD and UDM, CRM does find an estimate for ED95 and ED90. UDM underestimates both ED95 and ED90. BCD is close to the targeted EDs when the starting dose does not exceed the ED of interest, otherwise it overestimates it. CRM with cohorts of two patients is closest to the ED of interest independently of the starting doses. CRM requires between 20 and 50 observations, UDM should include 90 patients, and BCD 100 or 60 observations. Lastly, CRM is associated with fewer failures, compared with BCD and UDM. Conclusions: Based on Monte Carlo simulations, our work suggests that the UDM is not an adequate dose-finding method because it underestimates the ED of interest. Compared with BCD, CRM offers the advantages of being more efficient, requires fewer patients to be included, and is associated with fewer failures., SCOPUS: re.j, info:eu-repo/semantics/published

Venous access procedures are painful and feared by children and their parents. Virtual reality has become increasingly prominent and has been shown to be effective in various procedures. The aim of this meta-analysis was to examine virtual reality’s effect on pain and fear in children from 4 to 12 in the context of vascular access. From the 20th to the 26th December 2020, we searched Sciencedirect, Springerlink, CENTRAL, Pubmed and PMC. Studies using virtual reality versus a control in vascular access for children were included in a meta-analysis to evaluate the effect of virtual reality regarding pain as a primary and fear/anxiety as a secondary endpoint during the procedures. The Jadad scale and Delphi List were used to assess study quality. 20,894 citations were identified, 9 met our inclusion criteria. One publication was conducted in two different situations and was thus considered as 2 studies. Compared to standard of care, virtual reality significantly reduced pain (10 studies, 930 participants: standardized mean difference [SMD] 2.54, 95%CI 0.14–4.93, p = 0.038), and fear/anxiety (6 studies, 648 participants: SMD 0.89, 95%Cl 0.16–1.63, p = 0.017). For both parameters, we found significant heterogeneity between studies. This is the first meta-analysis to look at the use virtual reality in young children undergoing vascular access procedures, providing weak to moderate evidence for its use. Although large effect sizes provide evidence for a positive effect of virtual reality in reducing pain and fear, there is significant heterogeneity between studies. More research with larger groups and age stratification is required., SCOPUS: ar.j, info:eu-repo/semantics/published

SCOPUS: ar.j, info:eu-repo/semantics/published

Unbalanced fluid solutions cause metabolic acidosis and could be associated with impaired coagulation and increased blood loss., SCOPUS: ar.j, info:eu-repo/semantics/published

Objectives: To evaluate the failure rate and performance of cell-free DNA (cfDNA) testing as a first-line screening method for major trisomies, performed by two laboratories using different analytical methods: a targeted chromosome-selective method (Harmony® prenatal Test) versus a home-brew genome-wide (GW) massively parallel sequencing method (HB-cfDNA test), and to evaluate the clinical value of incidental findings for the latter method. Methods: CfDNA testing was performed in 3137 pregnancies with the Harmony® prenatal Test and in 3373 pregnancies with the HB-cfDNA test. Propensity score analysis was used to match women between both groups for maternal age, weight, gestational age at testing, in vitro fertilization, rate of twin pregnancies and that of aneuploidies. Detection rates for trisomy 21 were compared between the 2 laboratories. For the HB-cfDNA test, cases with rare incidental findings were reported, including their clinical follow-up. Results: The Harmony® prenatal Test failed at the first attempt in 90 (2.9%) of 3114 women and the HB-cfDNA test in 413 (12.2%) of 3373 women. Postmatched comparisons of the women’s characteristics indicate a significantly lower failure rate in the Harmony® group (2.8%) than in the HB cfDNA group (12.4%; p <.001). Of the 90 women in whom the Harmony® prenatal Test failed, 61 had a repeat test, which still failed in 10, and of the 413 women in whom the HB-cfDNA test failed, 379 had a repeat test, which still failed in 110. The total failure rate after one or two attempts was therefore 1.3% (39/3114) for Harmony® and 4.3% (144/3373) for the HB cfDNA test. After the first or second Harmony® prenatal Test, a high-risk result was noted in 17 of the 17 cases with trisomy 21, in 5 of the seven cases with trisomy 18, and a no-call in two cases, and in the one case with trisomy 13. The respective numbers for the HB-cfDNA test are 17 of the 18 cases with trisomy 21, and a no-call in one case, 2 of the two cases with trisomy 18, an, SCOPUS: ar.j, info:eu-repo/semantics/published

We conducted an international multicenter retrospective cohort study, PregOuTCOV, to examine the eff ect of gestational age at time of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on obstetric and neonatal outcomes. We included all singleton pregnancies with a live fetus at 10 weeks' gestation in which pregnancy outcomes were known. The exposed group consisted of patients infected with SARS-CoV-2, whereas the unexposed group consisted of all remaining patients during the same period. Primary outcomes were defi ned as composite adverse obstetric outcomes and composite adverse neonatal outcomes. Of 10,925 pregnant women, 393 (3.60%) were infected with SARSCoV- 2 (exposed group). After matching for possible confounders, we identifi ed statistically signifi cant increases in the exposed group of composite adverse obstetric outcomes at >20 weeks' gestation and of composite adverse neonatal outcomes at >26 weeks' gestation (p<0.001). Vaccination programs should target women early in pregnancy or before conception, if possible., SCOPUS: ar.j, info:eu-repo/semantics/published

Background Scheduled cesarean section is routinely performed under spinal anesthesia using hyperbaric bupivacaine. The current study was undertaken to determine the clinically relevant 95% effective dose of intrathecal 2% hyperbaric prilocaine co-administered with sufentanil for scheduled cesarean section, using continual reassessment method. Methods We conducted a dose-response, prospective, double-blinded study to determine the ED95 values of intrathecal hyperbaric prilocaine used with 2,5 mcg of sufentanil and 100 mcg of morphine for cesarean delivery. Each parturient enrolled in the study received an intrathecal dose of hyperbaric prilocaine determined by the CRM and the success or failure of the block was assessed as being the primary endpoint. Results The doses given for each cohort varied from 35 to 50 mg of HP, according to the CRM, with a final ED95 lying between 45 and 50 mg of Prilocaine after completion of the 10 cohorts. Few side effects were reported and patients were globally satisfied. Conclusions The ED95 of intrathecal hyperbaric prilocaine with sufentanil 2.5 μg and morphine 100 μg for elective cesarean delivery was found to be between 45 and 50 mg. It may be an interesting alternative to other long-lasting local anesthetics in this context. Trial registration The study was registered on January 30, 2017 – retrospectively registered – and results posted at the public database clinicaltrials.gov ( NCT03036384 )., info:eu-repo/semantics/published

OBJECTIVES: The upcoming release of aprotinin in paediatric cardiac surgery prompted a re-evaluation of its use in comparison to tranexamic acid (TXA) focusing on their effect on exposure to blood transfusions as well as severe postoperative morbidity or mortality. METHODS: This retrospective study was conducted in a tertiary children hospital from 2002 to 2015. Patients receiving aprotinin (Aprotinin group: 2002-2007) were compared with those receiving TXA group (2008-2015) using propensity score analysis. Primary outcome measures were 'exposure to blood products' and 'severe postoperative morbidity or mortality'. High-risk subgroups that included neonates, complex (Risk Adjusted Classification for Congenital Heart Surgery-1 ≥ 3) and redo surgery were also analysed. RESULTS: The study included 2157 patients, 1136 in the Aprotinin group and 1021 in the TXA group. Exposure to blood products was significantly higher in the Aprotinin group (78% vs 60%; P < 0.001) as well as in the complex and redo surgery subgroups. Incidence of mortality and/or severe morbidity was higher in the Aprotinin group (33% vs 28%; P = 0.007), as well as in the neonate group. However, cardiopulmonary bypass priming volume and intraoperative fluid balance were significantly decreased, and the use of modified ultrafiltration significantly increased in the TXA group. CONCLUSIONS: In our population, children receiving aprotinin were more frequently transfused and were at a higher risk of developing severe postoperative morbidity or mortality than those receiving TXA. Subgroups at high risk of bleeding or inflammation did not seem to benefit from aprotinin. These differences might be explained by a safer profile of TXA, but also attributed to major changes in our patient blood management strategies over years., SCOPUS: ar.j, info:eu-repo/semantics/published

info:eu-repo/semantics/published

Objectives To compare the outcomes of sickle cell disease patients diagnosed through neonatal screening with those who were not. Methods In an observational multicenter study in Belgium, 167 screened and 93 unscreened sickle cell disease patients were analyzed for a total of 1116 and 958 patient-years of follow-up, respectively. Both groups were compared with propensity score analysis, with patients matched on three covariates (gender, genotype, and central Africa origin). Bonferroni correction was applied for all comparisons. Results Kaplan-Meier estimates of survival without bacteremia were significantly higher in the screened group than the unscreened group (94.47%; [95% CI, 88.64-97.36%] versus 83.78% [95% CI, 72.27-90.42%]), p = 0.032. Non-significant differences between both groups were reported for survival without acute chest syndrome, acute anemia, cerebral complication, severe infection, and vaso-occlusive crisis. Significantly lower hospitalization rate and days per 100 patient-years were observed in the screened compared with the unscreened group (0.27 vs. 0.63 and 1.25 vs. 2.82, p = 0.0006 and <0.0001). Conclusion These data confirm the benefit of a neonatal screening programme in reducing bacteremia and hospitalization.