Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Study Overview
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Brief Summary
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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.

Official Title
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Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis

Conditions
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Dehydration, Gastroenteritis

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 6 months - 5 years Clinical diagnosis of acute gastroenteritis Mild or moderate dehydration as determined by validated clinical scale Clinical assessment to begin IV fluids Vomiting ≥ 2 episodes in past 4 hours Exclusion Criteria: Severe dehydration History of significant gastrointestinal, metabolic, renal or cardiac disorder Ondansetron allergy Non-English language proficient parent/guardian Parent/guardian has no telephone

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Saline | Drug: Saline<br> <br> |
| Active Comparator: 1<br>Zofran | Drug: Ondansetron<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Received further IV fluids |  | 2-7 days post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dehydration, acute gastroenteritis, ondansetron, rehydration