Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT00691275
First received: June 3, 2008
Last updated: October 21, 2009
Last verified: October 2009

June 3, 2008
October 21, 2009
September 2008
September 2009   (final data collection date for primary outcome measure)
Received further IV fluids [ Time Frame: 2-7 days post discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00691275 on ClinicalTrials.gov Archive Site
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Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Dehydration
  • Gastroenteritis
  • Drug: Ondansetron
  • Drug: Saline
  • Placebo Comparator: 2
    Saline
    Intervention: Drug: Saline
  • Active Comparator: 1
    Zofran
    Intervention: Drug: Ondansetron

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
198
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
6 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00691275
0801-012
No
Sam Reid, MD, Children's Hospitals and Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
Not Provided
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
Children's Hospitals and Clinics of Minnesota
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP