Multidose Ondansetron after Emergency Visits in Children with Gastroenteritis
Abstract
BACKGROUND
Ondansetron improves outcomes when administered in emergency departments to children with acute gastroenteritis-associated vomiting. It is commonly prescribed at discharge to reduce symptoms, but evidence to support this practice is limited.
METHODS
We conducted a double-blind, randomized superiority trial involving children 6 months to less than 18 years of age with acute gastroenteritis-associated vomiting in six pediatric emergency departments. Caregivers were provided with six doses of oral ondansetron or placebo to administer in response to ongoing vomiting during the first 48 hours after enrollment. The primary outcome was moderate-to-severe gastroenteritis, defined by a score of 9 or higher on the modified Vesikari scale (scores range from 0 to 20, with higher scores indicating greater severity), during the 7 days after enrollment. Secondary outcomes included the presence of vomiting, the duration of vomiting (defined as the time from enrollment to the last vomiting episode), the number of vomiting episodes within 48 hours after enrollment, unscheduled physician visits within 7 days after enrollment, and receipt of intravenous fluids.
RESULTS
A total of 1030 children underwent randomization. Moderate-to-severe gastroenteritis occurred in 5.1% (23 of 452 participants for whom data were available) in the ondansetron group and 12.5% (55 of 441) in the placebo group (unadjusted risk difference, -7.4 percentage points; 95% confidence interval [CI], -11.2 to…
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: 1,030 participants or records.
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