A meta-analysis of randomized controlled trials: combination of ketamine and propofol versus ketamine alone for procedural sedation and analgesia in children

Abstract Background Procedural sedation reduces patients’ discomfort and anxiety, facilitating performance of the examination and intervention. However, it may also cause adverse events, including airway obstruction and hypoxia. We conducted this systematic review and meta-analysis to evaluate the efficacy of high-flow nasal oxygenation (HFNO) compared with that of standard oxygen therapy in adult patients undergoing procedural sedation. Methods We identified randomized controlled trials published before November 2020 based on PubMed, Embase, and Cochrane Library databases and ClinicalTrials.gov registry. Intraprocedural desaturation [peripheral oxygen saturation (SpO2) < 90%] was evaluated as the primary outcome. The secondary outcomes were the lowest SpO2, need for airway intervention, oxygen therapy-related complications, and patient, operator, and anesthetist’s satisfaction. Results Six trials with a total of 2633 patients were reviewed. Patients using HFNO compared with standard oxygen therapy had a significantly lower risk of intraprocedural desaturation [risk ratio 0.18, 95% confidence interval (CI) 0.04-0.87]. The lowest intraprocedural SpO2 in HFNO group was significantly higher than that in standard oxygen therapy group (mean difference 4.19%, 95% CI 1.74-6.65). Conclusions Compared with standard oxygen therapy, HFNO may reduce the risk of desaturation and increase the lowest SpO2 in adult patients undergoing sedation for medical procedures.

Download Full-text

Efficacy and Safety of Remimazolam for Procedural Sedation: A Meta-Analysis of Randomized Controlled Trials With Trial Sequential Analysis

Frontiers in Medicine ◽

10.3389/fmed.2021.641866 ◽

2021 ◽

Vol 8 ◽

Author(s):

Bo-Jyun Jhuang ◽

Bo-Han Yeh ◽

Yen-Ta Huang ◽

Pei-Chun Lai

Keyword(s):

Randomized Controlled Trials ◽

Sequential Analysis ◽

Weighted Mean Difference ◽

Meta Analysis ◽

Verbal Learning ◽

Procedural Sedation ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Randomized Controlled ◽

Grade Methodology

Background: Remimazolam is a new ultrashort-acting benzodiazepine. Remimazolam has been approved for procedural sedation by the US Food and Drug Administration in 2020. However, prior trials and the participants they enrolled were limited.Aim: In this meta-analysis, we investigated the effectiveness and adverse events (AEs) of remimazolam during procedural sedation.Materials and Methods: The study protocol was registered (doi: 10.37766/inplasy2020.8.0043), and six databases were searched. We performed meta-analysis, trial sequential analysis (TSA), and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for judging the certainty of evidence (CoE).Results: A total of five randomized controlled trials with 1,248 participants were included. Compared with the use of midazolam, the utilization of remimazolam resulted in an increase in procedure success rate [odds ratio (OR) = 9.01, 95% confidence interval (CI): 2.35–34.57], a reduction in the application of rescue medication (OR = 13.58, 95% CI: 3.46–53.28), a decrease in time to recovery [minutes, weighted mean difference (WMD) = −5.70, 95% CI: −8.68 to −2.72], and a better cognitive recovery of Hopkins Verbal Learning Test-Revised (WMD = 5.22, 95% CI: 2.88–7.55). No difference was found in completion of procedure (OR = 1.68, 95% CI: 0.72–3.90) with inconclusive in TSA. Despite no difference of total AEs (OR = 0.60, 95% CI: 0.24–1.50), more detailed analysis of AEs remained inconclusive in TSA. The GRADE assessment demonstrated low to very low CoE.Conclusion: Our analysis suggested that remimazolam may be a better choice for procedural sedation than midazolam. Nevertheless, further studies are warranted to conclusively establish its safety.

Download Full-text