Ondansetron: A Tool for Home Management of Gastroenteritis
Abstract
Source: Freedman SB, Williamson-Urquhart S, Plint AC, et al. Multidose ondansetron after emergency visits in children with gastroenteritis. N Engl J Med. 2025;393(3):255-266; doi: 10.1056/NEJMoa2503596.Investigators from multiple institutions in Canada conducted a randomized controlled trial to assess the effectiveness of ondansetron in children with gastroenteritis following discharge from an emergency department (ED). Participants were patients 6 months to <18 years of age, seen in 1 of 6 EDs, who were diagnosed with gastroenteritis and treated with ondansetron in ED. Only children with at least 3 episodes of vomiting in the preceding 24 hours, including ≥1 episode in the prior 6 hours were enrolled. Eligible patients were randomized to receive up to 6 doses of ondansetron (0.15 mg/kg up to a maximum of 8 mg per dose) or placebo at the time of ED discharge. Caregivers were instructed to administer a dose of study medication as needed for nausea or vomiting, as often as every 8 hours, over a 7-day study period. Caregivers completed a survey at 24 and 48 hours, and at 7 days after enrollment. The survey included items on symptom presence and severity and outcomes. Survey results were used to calculate a modified Vesikari score, which includes 7 items designed to assess the severity of gastroenteritis; possible scores range from 0–20, with higher score indicative of more severe disease. The primary study outcome was moderate-to-severe gastroenteritis, defined as a Vesikari…
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: 517 participants or records.
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