Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial
Abstract
A total of 918 dehydrated Pakistani children with gastroenteritis-associated vomiting received oral ondansetron or placebo; children administered ondansetron were less likely to vomit and receive intravenous rehydration. BACKGROUND: Ondansetron is an effective antiemetic employed to prevent vomiting in children with gastroenteritis in high-income countries; data from low- and middle-income countries are sparse. METHODS: We conducted a randomized, double-blind, placebo-controlled superiority trial in 2 pediatric emergency departments in Pakistan. Dehydrated children aged 6 to 60 months with ≥1 diarrheal (ie, loose or liquid) stool and ≥1 vomiting episode within the preceding 4 hours were eligible to participate. Participants received a single weight-based dose of oral ondansetron (8–15 kg: 2 mg; >15 kg: 4 mg) or identical placebo. The primary outcome was intravenous administration of ≥20 mL/kg over 4 hours of an isotonic fluid within 72 hours of random assignment. RESULTS: All 918 (100%) randomly assigned children completed follow-up. Intravenous rehydration was administered to 14.7% (68 of 462) and 19.5% (89 of 456) of those administered ondansetron and placebo, respectively (difference: −4.8%; 95% confidence interval [CI], −9.7% to 0.0%). In multivariable logistic regression analysis adjusted for other antiemetic agents, antibiotics, zinc, and the number of vomiting episodes in the preceding 24 hours, children administered ondansetron had lower odds of the primary outcome…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 918 participants or records.
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