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Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial.
Pediatrics. 2019 12; 144(6)Ped

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.

Authors+Show Affiliations

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.Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan.Ontario Child Health Support Unit, SickKids Research Institute, Toronto, Ontario, Canada; and.Section of Pediatric Emergency Medicine, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.Centre of Excellence in Women and Child Health, The Aga Khan University, Karachi, Pakistan.Section of Pediatric Emergency Medicine, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.Section of Pediatric Emergency Medicine, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.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.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31694979

Citation

Freedman, Stephen B., et al. "Oral Ondansetron Administration to Dehydrated Children in Pakistan: a Randomized Clinical Trial." Pediatrics, vol. 144, no. 6, 2019.
Freedman SB, Soofi SB, Willan AR, et al. Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial. Pediatrics. 2019;144(6).
Freedman, S. B., Soofi, S. B., 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). https://doi.org/10.1542/peds.2019-2161
Freedman SB, et al. Oral Ondansetron Administration to Dehydrated Children in Pakistan: a Randomized Clinical Trial. Pediatrics. 2019;144(6) PubMed PMID: 31694979.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial. AU - Freedman,Stephen B, AU - Soofi,Sajid B, AU - Willan,Andrew R, AU - Williamson-Urquhart,Sarah, AU - Siddiqui,Emaduddin, AU - Xie,Jianling, AU - Dawoud,Fady, AU - Bhutta,Zulfiqar A, Y1 - 2019/11/06/ PY - 2019/09/04/accepted PY - 2019/11/7/pubmed PY - 2020/2/19/medline PY - 2019/11/8/entrez JF - Pediatrics JO - Pediatrics VL - 144 IS - 6 N2 - 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. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/31694979/Oral_Ondansetron_Administration_to_Dehydrated_Children_in_Pakistan:_A_Randomized_Clinical_Trial_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&amp;pmid=31694979 DB - PRIME DP - Unbound Medicine ER -