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Oral Ondansetron in Management of Dehydrating Diarrhea with Vomiting in Children Aged 3 Months to 5 Years: A Randomized Controlled Trial.
J Pediatr. 2016 Feb; 169:105-9.e3.JPed

Abstract

OBJECTIVES

To evaluate the role of oral ondansetron in facilitating successful rehydration of under-5-year-old children suffering from acute diarrhea with vomiting and some dehydration.

STUDY DESIGN

Children (n = 170) aged 3 months to 5 years with acute diarrhea with vomiting and some dehydration were enrolled in this double blind, randomized, placebo-controlled trial. The participants were randomized to receive either single dose of oral ondansetron (n = 85) or placebo (n = 85) in addition to standard management of dehydration according to World Health Organization guidelines. Failure of oral rehydration therapy (ORT), administration of unscheduled intravenous fluids, and amount of oral rehydration solution intake in 4 hours were the primary outcomes. Secondary outcome measures included duration of dehydration correction, number of vomiting episodes, adverse effects, and caregiver satisfaction.

RESULTS

Failure of ORT was significantly less in children receiving ondansetron compared with those receiving placebo (31% vs 62%; P < .001; relative risk 0.50, 95% CI 0.35-0.72). Almost one-half of the children in the ondansetron group received intravenous fluids compared with those in the placebo group, but it was not statistically significant (P = .074; relative risk 0.56, 95% CI 0.30-1.07). The oral rehydration solution consumption was significantly more in the ondansetron group (645 mL vs 554 mL; mean difference 91 mL; 95% CI: 35-148 mL). Patients in the ondansetron group also showed faster rehydration, lesser number of vomiting episodes, and better caregiver satisfaction.

CONCLUSION

A single oral dose of ondansetron, given before starting ORT to children <5 years of age with acute diarrhea and vomiting results in better oral rehydration.

TRIAL REGISTRATION

Clinical Trial Registry of India: CTRI-2011/07/001916.

Authors+Show Affiliations

Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India. Electronic address: shahdheeraj@hotmail.com.Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Department of Pharmacology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.Department of Pediatrics, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26654135

Citation

Danewa, Arun Singh, et al. "Oral Ondansetron in Management of Dehydrating Diarrhea With Vomiting in Children Aged 3 Months to 5 Years: a Randomized Controlled Trial." The Journal of Pediatrics, vol. 169, 2016, pp. 105-9.e3.
Danewa AS, Shah D, Batra P, et al. Oral Ondansetron in Management of Dehydrating Diarrhea with Vomiting in Children Aged 3 Months to 5 Years: A Randomized Controlled Trial. J Pediatr. 2016;169:105-9.e3.
Danewa, A. S., Shah, D., Batra, P., Bhattacharya, S. K., & Gupta, P. (2016). Oral Ondansetron in Management of Dehydrating Diarrhea with Vomiting in Children Aged 3 Months to 5 Years: A Randomized Controlled Trial. The Journal of Pediatrics, 169, 105-e3. https://doi.org/10.1016/j.jpeds.2015.10.006
Danewa AS, et al. Oral Ondansetron in Management of Dehydrating Diarrhea With Vomiting in Children Aged 3 Months to 5 Years: a Randomized Controlled Trial. J Pediatr. 2016;169:105-9.e3. PubMed PMID: 26654135.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral Ondansetron in Management of Dehydrating Diarrhea with Vomiting in Children Aged 3 Months to 5 Years: A Randomized Controlled Trial. AU - Danewa,Arun Singh, AU - Shah,Dheeraj, AU - Batra,Prerna, AU - Bhattacharya,Swapan Kumar, AU - Gupta,Piyush, Y1 - 2015/12/01/ PY - 2015/06/08/received PY - 2015/08/25/revised PY - 2015/10/02/accepted PY - 2015/12/15/entrez PY - 2015/12/15/pubmed PY - 2016/6/2/medline SP - 105 EP - 9.e3 JF - The Journal of pediatrics JO - J Pediatr VL - 169 N2 - OBJECTIVES: To evaluate the role of oral ondansetron in facilitating successful rehydration of under-5-year-old children suffering from acute diarrhea with vomiting and some dehydration. STUDY DESIGN: Children (n = 170) aged 3 months to 5 years with acute diarrhea with vomiting and some dehydration were enrolled in this double blind, randomized, placebo-controlled trial. The participants were randomized to receive either single dose of oral ondansetron (n = 85) or placebo (n = 85) in addition to standard management of dehydration according to World Health Organization guidelines. Failure of oral rehydration therapy (ORT), administration of unscheduled intravenous fluids, and amount of oral rehydration solution intake in 4 hours were the primary outcomes. Secondary outcome measures included duration of dehydration correction, number of vomiting episodes, adverse effects, and caregiver satisfaction. RESULTS: Failure of ORT was significantly less in children receiving ondansetron compared with those receiving placebo (31% vs 62%; P < .001; relative risk 0.50, 95% CI 0.35-0.72). Almost one-half of the children in the ondansetron group received intravenous fluids compared with those in the placebo group, but it was not statistically significant (P = .074; relative risk 0.56, 95% CI 0.30-1.07). The oral rehydration solution consumption was significantly more in the ondansetron group (645 mL vs 554 mL; mean difference 91 mL; 95% CI: 35-148 mL). Patients in the ondansetron group also showed faster rehydration, lesser number of vomiting episodes, and better caregiver satisfaction. CONCLUSION: A single oral dose of ondansetron, given before starting ORT to children <5 years of age with acute diarrhea and vomiting results in better oral rehydration. TRIAL REGISTRATION: Clinical Trial Registry of India: CTRI-2011/07/001916. SN - 1097-6833 UR - https://www.unboundmedicine.com/medline/citation/26654135/Oral_Ondansetron_in_Management_of_Dehydrating_Diarrhea_with_Vomiting_in_Children_Aged_3_Months_to_5_Years:_A_Randomized_Controlled_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(15)01165-8 DB - PRIME DP - Unbound Medicine ER -