Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Not Applicable

Withdrawn

• Conditions: Dehydration; Gastroenteritis
• Interventions: Drug: Saline; Drug: Ondansetron

• Registration Number: NCT00691275
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Study Start: 2008-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Saline	Saline
1	Ondansetron	Zofran

Primary Outcome Measures

Name	Time	Method
Received further IV fluids	2-7 days post discharge