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| Sponsor: | Children's Hospitals and Clinics of Minnesota |
|---|---|
| Information provided by: | Children's Hospitals and Clinics of Minnesota |
| ClinicalTrials.gov Identifier: | NCT00691275 |
Purpose
Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy.
Four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial [1-4]. A previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients [5]. None of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . In addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures.
The proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. If ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. If it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved.
Hypothesis:
Patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.
| Condition | Intervention |
|---|---|
|
Dehydration Gastroenteritis |
Drug: Ondansetron Drug: Saline |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis |
| Estimated Enrollment: | 198 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2: Placebo Comparator
Saline
|
Drug: Saline |
|
1: Active Comparator
Zofran
|
Drug: Ondansetron |
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | Sam Reid, MD | Children's Hospitals and Clinics of Minnesota |
| Principal Investigator: | Henry Ortega, MD | Children's Hospitals and Clinics of Minnesota |
| Principal Investigator: | Jeffrey Louie, MD | Children's Hospitals and Clinics of Minnesota |
More Information
| Responsible Party: | Children's Hospitals and Clinics of Minnesota ( Sam Reid, MD ) |
| Study ID Numbers: | 0801-012 |
| Study First Received: | June 3, 2008 |
| Last Updated: | October 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00691275 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
dehydration acute gastroenteritis ondansetron rehydration |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Psychotropic Drugs Antiemetics Serotonin Antagonists Pathologic Processes Therapeutic Uses Antipruritics Water-Electrolyte Imbalance Ondansetron Dermatologic Agents Metabolic Diseases |
Tranquilizing Agents Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions Digestive System Diseases Serotonin Agents Autonomic Agents Anti-Anxiety Agents Peripheral Nervous System Agents Gastroenteritis Central Nervous System Agents Dehydration |