Oral ondansetron administration to dehydrated children in Pakistan: A randomized clinical trial

Authors

Stephen B. Freedman, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Sajid Bashir Soofi, Aga Khan UniversityFollow
Andrew R. Willan, Ontario Child Health Support Unit, Sickkids Research Institute, Toronto, Ontario, Canada
Sarah Williamson-Urquhart, School of Medicine, University of Calgary, Calgary, Alberta, Canada
Emaduddin Siddiqui, Aga Khan UniversityFollow
Jianling Xie, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Fady Dawoud, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
Zulfiqar Ahmed Bhutta, Aga Khan UniversityFollow

Document Type

Article

Department

Paediatrics and Child Health; Emergency Medicine; Women and Child Health

Abstract

Background: Ondansetron is an effective antiemetic employed to prevent vomiting in children with gastroenteritis in high-income countries; data from low- and middle-income countries are sparse.
Methods: We conducted a randomized, double-blind, placebo-controlled superiority trial in 2 pediatric emergency departments in Pakistan. Dehydrated children aged 6 to 60 months with ≥1 diarrheal (ie, loose or liquid) stool and ≥1 vomiting episode within the preceding 4 hours were eligible to participate. Participants received a single weight-based dose of oral ondansetron (8–15 kg: 2 mg; >15 kg: 4 mg) or identical placebo. The primary outcome was intravenous administration of ≥20 mL/kg over 4 hours of an isotonic fluid within 72 hours of random assignment.
Results: All 918 (100%) randomly assigned children completed follow-up. Intravenous rehydration was administered to 14.7% (68 of 462) and 19.5% (89 of 456) of those administered ondansetron and placebo, respectively (difference: −4.8%; 95% confidence interval [CI], −9.7% to 0.0%). In multivariable logistic regression analysis adjusted for other antiemetic agents, antibiotics, zinc, and the number of vomiting episodes in the preceding 24 hours, children administered ondansetron had lower odds of the primary outcome (odds ratio: 0.70; 95% CI, 0.49 to 1.00). Fewer children in the ondansetron, relative to the placebo group vomited during the observation period (difference: −12.9%; 95% CI, −18.0% to −7.8%). The median number of vomiting episodes (P < .001) was lower in the ondansetron group.
Conclusions: Among children with gastroenteritis-associated vomiting and dehydration, oral ondansetron administration reduced vomiting and intravenous rehydration use. Ondansetron use may be considered to promote oral rehydration therapy success among dehydrated children in low- and middle-income countries.

Comments

Pagination are not provided by the author/publisher

Publication (Name of Journal)

Pediatrics

Recommended Citation

Freedman, S. B., Soofi, S., Willan, A. R., Williamson-Urquhart, S., Siddiqui, E., Xie, J., Dawoud, F., Bhutta, Z. A. (2019). Oral ondansetron administration to dehydrated children in Pakistan: A randomized clinical trial. Pediatrics, 144(6).
Available at: https://ecommons.aku.edu/pakistan_fhs_mc_women_childhealth_paediatr/828