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Sponsors and Collaborators: |
The Hospital for Sick Children National Center for Research Resources (NCRR) GlaxoSmithKline Children's Memorial Hospital |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00120744 |
The objectives of the study were to determine whether ondansetron treatment would reduce:
Condition | Intervention |
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Gastroenteritis Vomiting Diarrhea Dehydration |
Drug: Ondansetron Oral Disintegrating Tablet |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Study Completion Date: | April 2005 |
Background:
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.
Methods:
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.
Ages Eligible for Study: | 6 Months to 10 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2003-12038 |
Study First Received: | July 12, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00120744 |
Health Authority: | United States: Institutional Review Board |
Diarrhea Vomiting Metabolic Diseases Signs and Symptoms, Digestive Gastrointestinal Diseases Serotonin Signs and Symptoms |
Digestive System Diseases Emergencies Water-Electrolyte Imbalance Ondansetron Gastroenteritis Metabolic disorder Dehydration |
Neurotransmitter Agents Disease Attributes Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Serotonin Agents Pathologic Processes Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |