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Oral ondansetron for paediatric gastroenteritis in primary care: a randomised controlled trial
Irma J Bonvanie1, Anouk Ah Weghorst1, Gea A Holtman1
1Department of General Practice and Elderly Care Medicine, University of Groningen, The Netherlands.
Insights
Ondansetron significantly reduced vomiting in children with acute gastroenteritis (AGE) in primary care. This treatment improved parental satisfaction and reduced dehydration risk, enhancing general practice care.
Area of Science:
- Pediatric Medicine
- Gastroenterology
- Clinical Pharmacology
Background:
- Acute gastroenteritis (AGE) is a common childhood illness, particularly in those under 5 years.
- Vomiting associated with AGE can lead to dehydration and distress.
- Ondansetron has shown efficacy in reducing vomiting in secondary care settings.
Purpose of the Study:
- To evaluate the effectiveness of adding oral ondansetron to usual care for treating vomiting in children with AGE.
- To assess ondansetron's impact on vomiting frequency and parental satisfaction in an out-of-hours primary care setting.
Main Methods:
- A pragmatic randomized controlled trial was conducted in three out-of-hours primary care centers.
- 194 children aged 6 months to 6 years with diagnosed AGE and significant vomiting were randomized.
- The intervention group received oral ondansetron (0.1 mg/kg) plus oral rehydration therapy, while the control group received only oral rehydration therapy.
Main Results:
- A single dose of oral ondansetron reduced the proportion of children with persistent vomiting within 4 hours from 42.9% to 19.5%.
- Ondansetron significantly decreased the number of vomiting episodes and improved overall parental satisfaction with treatment (P=0.027).
- The number needed to treat with ondansetron was four to prevent ongoing vomiting.
Conclusions:
- Oral ondansetron is effective in primary care for reducing vomiting in children with AGE, mitigating dehydration risk.
- This intervention improves treatment efficacy and parental satisfaction, offering a valuable addition to general practice.
- Ondansetron use in primary care can enhance the quality and effectiveness of managing pediatric gastroenteritis.
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.
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