Working… Menu

Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00691275
Recruitment Status : Withdrawn
First Posted : June 5, 2008
Last Update Posted : July 14, 2015
Information provided by:
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.


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 or disease Intervention/treatment Phase
Dehydration Gastroenteritis Drug: Ondansetron Drug: Saline Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis
Study Start Date : September 2008
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: 2
Drug: Saline
Active Comparator: 1
Drug: Ondansetron

Primary Outcome Measures :
  1. Received further IV fluids [ Time Frame: 2-7 days post discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00691275

Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Sam Reid, MD, Children's Hospitals and Clinics of Minnesota Identifier: NCT00691275    
Other Study ID Numbers: 0801-012
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: July 14, 2015
Last Verified: July 2015
Keywords provided by Children's Hospitals and Clinics of Minnesota:
acute gastroenteritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Diseases
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents