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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Dehydration
Gastroenteritis
Drug: Ondansetron
Drug: Saline

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • Received further IV fluids [ Time Frame: 2-7 days post discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 198
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)
Arms Assigned Interventions
Placebo Comparator: 2
Saline
Drug: Saline
Active Comparator: 1
Zofran
Drug: Ondansetron

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691275

Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
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
  More Information

Publications:
Responsible Party: Sam Reid, MD, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT00691275     History of Changes
Other Study ID Numbers: 0801-012
Study First Received: June 3, 2008
Last Updated: October 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
dehydration
acute gastroenteritis
ondansetron
rehydration

Additional relevant MeSH terms:
Gastroenteritis
Dehydration
Gastrointestinal Diseases
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
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

ClinicalTrials.gov processed this record on September 18, 2014