Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
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|ClinicalTrials.gov Identifier: NCT00120744|
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : April 18, 2018
The objectives of the study were to determine whether ondansetron treatment would reduce:
- the amount of vomiting in the emergency department;
- the need for intravenous rehydration; and
- the need for hospitalization.
|Condition or disease||Intervention/treatment||Phase|
|Gastroenteritis Vomiting Diarrhea Dehydration||Drug: Ondansetron Oral Disintegrating Tablet||Not Applicable|
Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase.
The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2005|
- The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo.
- To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120744
|Principal Investigator:||Stephen B Freedman, MDCM, MSCI||The Hospital for Sick Children|