Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial.

Autor:	Freedman SB; Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital and Alberta Children's Hospital Research Institute and stephen.freedman@ahs.ca., Soofi SB; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan., Willan AR; Ontario Child Health Support Unit, SickKids Research Institute, Toronto, Ontario, Canada; and., Williamson-Urquhart S; Section of Pediatric Emergency Medicine, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada., Siddiqui E; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan., Xie J; Section of Pediatric Emergency Medicine, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada., Dawoud F; Section of Pediatric Emergency Medicine, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada., Bhutta ZA; Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan.; Centre for Global Child Health, The Hospital for Sick Children, Toronto, Ontario, Canada.
Jazyk:	angličtina
Zdroj:	Pediatrics [Pediatrics] 2019 Dec; Vol. 144 (6). Date of Electronic Publication: 2019 Nov 06.
DOI:	10.1542/peds.2019-2161
Abstrakt:	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. Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors declare in-kind support in the form of provision of the study drug and placebo by GlaxoSmithKline, Inc; Dr Freedman provides consultancy services to Takeda Pharmaceutical Company, Ltd. (Copyright © 2019 by the American Academy of Pediatrics.)
Databáze:	MEDLINE
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