PT - JOURNAL ARTICLE AU - Anouk AH Weghorst AU - Gea A Holtman AU - Irma J Bonvanie AU - Pien I Wolters AU - Boudewijn J Kollen AU - Karin M Vermeulen AU - Marjolein Y Berger TI - Cost-effectiveness of oral ondansetron for children with acute gastroenteritis in primary care: a randomised controlled trial AID - 10.3399/BJGP.2020.1093 DP - 2021 May 10 TA - British Journal of General Practice PG - BJGP.2020.1093 4099 - http://bjgp.org/content/early/2021/05/14/BJGP.2020.1093.short 4100 - http://bjgp.org/content/early/2021/05/14/BJGP.2020.1093.full AB - Background: Acute gastroenteritis is a common childhood disease with substantial medical and indirect costs, mostly because of referral, hospitalization and parental absence from work. Aim: To determine the cost-effectiveness of adding oral ondansetron to care-as-usual for children with acute gastroenteritis in out-of-hours primary care. Design and setting: A pragmatic randomised controlled trial at three out-of-hours primary care centres, with a follow-up of 7 days. Method: Inclusion criteria were: 1) age 6 months to 6 years; 2) diagnosis of acute gastroenteritis; 3) at least four reported episodes of vomiting 24 hours before presentation, whereof; 4) at least one in the 4 hours before presentation; and 5) written informed consent from both parents. Children were randomly allocated in a 1:1 ratio to either care-as-usual (oral rehydration therapy) or care-as-usual 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%, with an odds ratio of 0.4 (95% CI = 0.2–0.7, NNT 4). Total mean costs in the ondansetron group were 31.2% lower (€488 vs €709), and the total incremental mean costs for an additional child free of vomiting in the first 4 hours was −€9 (95% confidence interval, −€41 to €3). Conclusion: A single oral dose of ondansetron for children with acute gastroenteritis, given in out-of-hours primary care settings, is both clinically beneficial and cost-effective.