Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
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 . 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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis|
- Received further IV fluids [ Time Frame: 2-7 days post discharge ] [ Designated as safety issue: No ]
|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)|
Placebo Comparator: 2
Active Comparator: 1
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691275
|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|