Lower risk for moderate-to-severe gastroenteritis seen during seven days after enrollment with oral ondansetron versus placebo
By Elana Gotkine HealthDay Reporter
FRIDAY, July 18, 2025 (HealthDay News) — For children with gastroenteritis-associated vomiting, the provision of oral ondansetron after an emergency department visit is associated with a lower risk for moderate-to-severe gastroenteritis within the following seven days, according to a study published in the July 17 issue of the New England Journal of Medicine.
Stephen B. Freedman, M.D.C.M., from the University of Calgary in Alberta, Canada, and colleagues conducted a randomized, superiority trial involving 1,030 children aged 6 months to less than 18 years with acute gastroenteritis-associated vomiting in six pediatric emergency departments. In response to ongoing vomiting during the first 48 hours after enrollment, caregivers were provided with six doses of oral ondansetron or placebo. Moderate-to-severe gastroenteritis, defined by a score of 9 or higher on the modified Vesikari scale during the seven days after enrollment was the primary outcome.
The researchers found that moderate-to-severe gastroenteritis occurred in 5.1 percent of 452 participants in the ondansetron group and in 12.5 percent of 441 participants in the placebo group (unadjusted risk difference, −7.4 percentage points). Ondansetron was associated with a lower risk for moderate-to-severe gastroenteritis than placebo after adjustment for site, weight, and missing data (adjusted odds ratio, 0.50). The total number of vomiting episodes within 48 hours after enrollment was lower with ondansetron than placebo (adjusted rate ratio, 0.76), although no meaningful difference was seen between the groups in the presence or median duration of vomiting.
“The provision of ondansetron to children after an emergency department visit for recent and frequent vomiting due to acute gastroenteritis was beneficial,” the authors write.
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