Updated evidence on efficacy and safety of ondansetron compared with placebo for acute gastroenteritis-associated vomiting in children: a systematic review and meta-analysis of randomized controlled trials
Abstract
Background Acute gastroenteritis (AGE) is among the most common causes of pediatric emergency care, and ondansetron is now widely used to control the vomiting that drives failure of oral rehydration therapy (ORT). The most recent comprehensive meta-analysis on this topic was published in 2020 and could not incorporate the subsequently published multidose post-discharge trial, did not evaluate the volume of ORT tolerated, and did not formally explore sources of heterogeneity through meta-regression; this update was undertaken to address these gaps. Methods The systematic review and meta-analysis was conducted and reported in accordance with the PRISMA 2020 statement, and its conduct was additionally guided by the AMSTAR 2 critical appraisal tool. A literature search was done in PubMed, CENTRAL, ScienceDirect, Google Scholar, and ClinicalTrials.gov until June 2026 for randomized controlled trials involving the use of ondansetron versus placebo in children with AGE-associated vomiting. Bias was assessed using RoB 2, while evidence certainty was assessed using GRADE. Random-effect models computed pooled risk ratios (RR) and mean differences (MD). Results Sixteen RCTs comprising 3,415 randomized/allocated children from 12 countries met the inclusion criteria. Ondansetron significantly reduced ongoing vomiting (RR 0.48), the number of vomiting episodes (MD − 0.73), failure of oral rehydration therapy (RR 0.39), and use of intravenous fluids (RR 0.57), and significantly increased…
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