Cost-effectiveness of oral ondansetron for children with acute gastroenteritis in primary care: a randomised controlled trial

BACKGROUND: Acute gastroenteritis is a common childhood condition with substantial medical and indirect costs, mostly because of referral, hospitalisation, and parental absence from work. AIM: To determine the cost-effectiveness of adding oral ondansetron to care as usual (CAU) for children with acute gastroenteritis presenting to out-of-hours primary care (OOH-PC). DESIGN AND SETTING: A pragmatic randomised controlled trial from December 2015 to January 2018, at three OOHPC centres in the north of the Netherlands (Groningen, Zwolle, and Assen) with a follow-up of 7 days. METHOD: Children were recruited at the OOH-PC and parents kept a parental diary. Inclusion criteria were: aged 6 months–6 years; diagnosis of acute gastroenteritis; at least four reported episodes of vomiting 24 hours before presentation, at least one of which was in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated at a 1:1 ratio to either CAU (oral rehydration therapy) or CAU plus one dose of 0.1 mg/kg oral ondansetron. RESULTS: In total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within the first 4 hours from 42.9% to 19.5%, (a decrease of 54.5%), with an odds ratio of 0.4 (95% confidence interval [CI] = 0.2 to 0.7; number needed to treat: four). Total mean costs in the ondansetron group were 31.2% lower (€488 [£420] versus €709 [£610]), and the total incremental mean costs for an additional child free of vomiting in the first 4 hours was −€9 (£8) (95% CI = −€41 [£35] to €3 [£3]). CONCLUSION: A single oral dose of ondansetron for children with acute gastroenteritis, given in OOH-PC settings, is both clinically beneficial and cost-effective.