Ondansetron home use for pediatric acute gastroenteritis vomiting after ED discharge
This secondary analysis of a randomized clinical trial included 977 children aged 6 months to less than 18 years who presented to emergency departments with acute gastroenteritis-associated vomiting. The analysis examined outcomes after emergency department discharge in a population that had received ondansetron for home use in the parent trial.
The primary outcome was 3 or more episodes of vomiting within 24 hours of emergency department discharge, occurring in 80 of 927 children (8.6%). Among these 80 children with persistent vomiting, 33 of 80 (41.3%) had an unscheduled health care revisit within 7 days, compared to 65 of 846 (7.7%) without persistent vomiting, a difference of 33.6% (95% CI, 22.6%-44.5%).
Intravenous fluid administration within 7 days occurred in 9 of 80 (11.3%) versus 15 of 846 (1.8%), a difference of 9.5% (95% CI, 2.5%-16.5%). Hospitalization within 7 days occurred in 5 of 80 (6.2%) versus 9 of 846 (1.1%), a difference of 5.2% (95% CI, -0.2% to 10.5%).
Safety and tolerability data were not reported. Key limitations include the nonprespecified secondary analysis and that follow-up data were available for 977 of 1030 enrolled children. The practice relevance suggests younger children and those with longer symptom duration or more vomiting episodes at presentation may be more likely to have persistent vomiting after discharge.
These findings are observational associations from a secondary analysis and do not support causal inference or sole reliance on this analysis for ondansetron recommendations.