RT Journal Article SR Electronic T1 Oral ondansetron for paediatric gastroenteritis in primary care: a randomised controlled trial JF British Journal of General Practice JO Br J Gen Pract FD British Journal of General Practice SP BJGP.2021.0211 DO 10.3399/BJGP.2021.0211 A1 Irma Bonvanie A1 Anouk AH Weghorst A1 Gea Holtman A1 Heleen A Russchen A1 Freek Fickweiler A1 Henkjan J Verkade A1 Boudewijn J Kollen A1 Marjolein Berger YR 2021 UL http://bjgp.org/content/early/2021/06/25/BJGP.2021.0211.abstract AB Background: Acute gastroenteritis affects almost all children younger than 5 years. Due to vomiting the standard oral rehydration therapy (ORT) treatment is less effective. In secondary care, ondansetron was found to be effective in reducing vomiting. Aim: To determine the effectiveness of adding oral ondansetron to care-as-usual on vomiting in children with acute gastroenteritis attending out-of-hours primary care. Design and setting: A pragmatic randomised controlled trial with a follow-up of 7 days, at three out-of-hours primary care centres. Method: Inclusion criteria: 1) age 6 months to 6 years, 2) acute gastroenteritis diagnosed by a general practitioner, 3) at least four reported episodes of vomiting in the 24 hours before presentation, 4) at least one reported episode of vomiting in the 4 hours before presentation, and 5) written informed consent from both parents. The control group received care-as-usual (ORT). The intervention group received care-as-usual plus one dose of oral ondansetron (0.1 mg/kg). Results: In total, 194 children were included for randomisation. One dose of oral ondansetron decreased the proportion of children who continued vomiting within 4 hours from 42.9% to 19.5%, with an odds ratio of 0.37 (95% CI = 0.20–0.72, NNT 4). Ondansetron also decreased the number of vomiting episodes within 4 hours, incidence rate ratio of 0.51 (95% CI, 0.29-0.88), and improved overall parental satisfaction with treatment (p = 0.027). Conclusions: Ondansetron decreased vomiting and increased parental satisfaction in children with acute gastroenteritis. We were not able to show an increased ORT intake or decrease in referral rate.