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Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: A Randomized Controlled Trial.
Ann Emerg Med. 2019 03; 73(3):255-265.AE

Abstract

STUDY OBJECTIVE

We determine whether single-dose oral ondansetron administration to children with vomiting as a result of acute gastroenteritis without dehydration reduces administration of intravenous fluid rehydration.

METHODS

In this 2-hospital, double-blind, placebo-controlled, emergency department-based, randomized trial conducted in Karachi Pakistan, we recruited children aged 0.5 to 5.0 years, without dehydration, who had diarrhea and greater than or equal to 1 episode of vomiting within 4 hours of arrival. Patients were randomly assigned (1:1), through an Internet-based randomization service using a stratified variable-block randomization scheme, to single-dose oral ondansetron or placebo. The primary endpoint was intravenous rehydration (administration of ≥20 mL/kg of an isotonic fluid during 4 hours) within 72 hours of randomization.

RESULTS

Participant median age was 15 months (interquartile range 10 to 26) and 59.4% (372/626) were male patients. Intravenous rehydration use was 12.1% (38/314) and 11.9% (37/312) in the placebo and ondansetron groups, respectively (odds ratio 0.98; 95% confidence interval [CI] 0.60 to 1.61; difference 0.2%; 95% CI of the difference -4.9% to 5.4%). Bolus fluid administration occurred within 72 hours of randomization in 10.8% (34/314) and 10.3% (27/312) of children administered placebo and ondansetron, respectively (odds ratio 0.95; 95% CI 0.56 to 1.59). A multivariable regression model fitted with treatment group and adjusted for antiemetic administration, antibiotics, zinc prerandomization, and vomiting frequency prerandomization yielded similar results (odds ratio 0.91; 95% CI 0.55 to 1.53). There was no interaction between treatment group and age, greater than or equal to 3 stools in the preceding 24 hours, or greater than or equal to 3 vomiting episodes in the preceding 24 hours.

CONCLUSION

Oral administration of a single dose of ondansetron did not result in a reduction in intravenous rehydration use. In children without dehydration, ondansetron does not improve clinical outcomes.

Authors+Show Affiliations

Section of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Section of Pediatric Gastroenterology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Department of Paediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address: stephen.freedman@ahs.ca.Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.Ontario Child Health Support Unit, Sickkids Research Institute, Toronto, Ontario, Canada.Section of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.Centre of Excellence in Women and Child Health, Aga Khan University, Karachi, Pakistan.Section of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.Section of Pediatric Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.Centre of Excellence in Women and Child Health, 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
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30392735

Citation

Freedman, Stephen B., et al. "Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: a Randomized Controlled Trial." Annals of Emergency Medicine, vol. 73, no. 3, 2019, pp. 255-265.
Freedman SB, Soofi SB, Willan AR, et al. Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: A Randomized Controlled Trial. Ann Emerg Med. 2019;73(3):255-265.
Freedman, S. B., Soofi, S. B., Willan, A. R., Williamson-Urquhart, S., Ali, N., Xie, J., Dawoud, F., & Bhutta, Z. A. (2019). Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: A Randomized Controlled Trial. Annals of Emergency Medicine, 73(3), 255-265. https://doi.org/10.1016/j.annemergmed.2018.09.011
Freedman SB, et al. Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: a Randomized Controlled Trial. Ann Emerg Med. 2019;73(3):255-265. PubMed PMID: 30392735.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral Ondansetron Administration to Nondehydrated Children With Diarrhea and Associated Vomiting in Emergency Departments in Pakistan: A Randomized Controlled Trial. AU - Freedman,Stephen B, AU - Soofi,Sajid B, AU - Willan,Andrew R, AU - Williamson-Urquhart,Sarah, AU - Ali,Noshad, AU - Xie,Jianling, AU - Dawoud,Fady, AU - Bhutta,Zulfiqar A, Y1 - 2018/11/02/ PY - 2018/07/20/received PY - 2018/09/04/revised PY - 2018/09/10/accepted PY - 2018/11/6/pubmed PY - 2020/2/1/medline PY - 2018/11/6/entrez SP - 255 EP - 265 JF - Annals of emergency medicine JO - Ann Emerg Med VL - 73 IS - 3 N2 - STUDY OBJECTIVE: We determine whether single-dose oral ondansetron administration to children with vomiting as a result of acute gastroenteritis without dehydration reduces administration of intravenous fluid rehydration. METHODS: In this 2-hospital, double-blind, placebo-controlled, emergency department-based, randomized trial conducted in Karachi Pakistan, we recruited children aged 0.5 to 5.0 years, without dehydration, who had diarrhea and greater than or equal to 1 episode of vomiting within 4 hours of arrival. Patients were randomly assigned (1:1), through an Internet-based randomization service using a stratified variable-block randomization scheme, to single-dose oral ondansetron or placebo. The primary endpoint was intravenous rehydration (administration of ≥20 mL/kg of an isotonic fluid during 4 hours) within 72 hours of randomization. RESULTS: Participant median age was 15 months (interquartile range 10 to 26) and 59.4% (372/626) were male patients. Intravenous rehydration use was 12.1% (38/314) and 11.9% (37/312) in the placebo and ondansetron groups, respectively (odds ratio 0.98; 95% confidence interval [CI] 0.60 to 1.61; difference 0.2%; 95% CI of the difference -4.9% to 5.4%). Bolus fluid administration occurred within 72 hours of randomization in 10.8% (34/314) and 10.3% (27/312) of children administered placebo and ondansetron, respectively (odds ratio 0.95; 95% CI 0.56 to 1.59). A multivariable regression model fitted with treatment group and adjusted for antiemetic administration, antibiotics, zinc prerandomization, and vomiting frequency prerandomization yielded similar results (odds ratio 0.91; 95% CI 0.55 to 1.53). There was no interaction between treatment group and age, greater than or equal to 3 stools in the preceding 24 hours, or greater than or equal to 3 vomiting episodes in the preceding 24 hours. CONCLUSION: Oral administration of a single dose of ondansetron did not result in a reduction in intravenous rehydration use. In children without dehydration, ondansetron does not improve clinical outcomes. SN - 1097-6760 UR - https://www.unboundmedicine.com/medline/citation/30392735/Oral_Ondansetron_Administration_to_Nondehydrated_Children_With_Diarrhea_and_Associated_Vomiting_in_Emergency_Departments_in_Pakistan:_A_Randomized_Controlled_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0196-0644(18)31269-1 DB - PRIME DP - Unbound Medicine ER -