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.
Cost analysis of nurse telephone consultation in out of hours primary care: evidence from a randomised controlled trial
