Oral ondansetron for paediatric gastroenteritis in primary care: a randomised controlled trial

Abstract

Background: Acute gastroenteritis (AGE) affects almost all children aged ≤5 years. In secondary care, ondansetron was found to be effective at reducing vomiting.

Aim: To determine the effectiveness of adding oral ondansetron to care as usual (CAU) to treat vomiting in children with AGE attending out-ofhours primary care (OOH-PC).

Design and setting: A pragmatic randomised controlled trial at three OOH-PC centres in the north of the Netherlands (Groningen, Zwolle, and Assen), with a follow-up of 7 days.

Method: Children were included if they were: aged 6 months-6 years; AGE diagnosed by a GP; ≥4 reported episodes of vomiting in the 24 hours before presentation; ≥1 reported episode of vomiting in the 4 hours before presentation; and written informed consent from both parents. Children were randomly allocated to either the control group or the intervention group. The control group received CAU, namely oral rehydration therapy. The intervention group received CAU 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% confidence interval [CI] = 0.20 to 0.72, number needed to treat: four). Ondansetron also decreased the number of vomiting episodes within 4 hours (incidence rate ratio 0.51 [95% CI = 0.29 to 0.88]) and improved overall parental satisfaction with treatment (P = 0.027).

Conclusion: Children with AGE and increased risk of dehydration due to vomiting could be treated with ondansetron in primary care to stop vomiting more quickly and increase parental satisfaction with treatment. These results could be used to improve the quality and efficacy of general practice medicine.

Keywords: acute gastroenteritis; child; oral ondansetron; out of hours; primary care; vomiting.

Figure 1.

Participant pathway. ^a Excluded from trial because of no informed consent of second parent (n = 8) or active withdrawal from study (retracted informed consent) (n = 1). ^b Excluded from PP and safety analyses because participants did not receive the allocated intervention (n = 10) or data were lost to follow-up (n = 3). AGE = acute gastroenteritis. CAU = care as usual. ITT = intention to treat. PP = per protocol.