Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
This study has been withdrawn prior to recruitment.
First Received: June 3, 2008   Last Updated: October 21, 2009   History of Changes
Sponsor: Children's Hospitals and Clinics of Minnesota
Information provided by: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT00691275
  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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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
2: Placebo Comparator
Saline
Drug: Saline
1: Active Comparator
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
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: Children's Hospitals and Clinics of Minnesota ( Sam Reid, MD )
Study ID Numbers: 0801-012
Study First Received: June 3, 2008
Last Updated: October 21, 2009
ClinicalTrials.gov Identifier: NCT00691275     History of Changes
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:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Serotonin Antagonists
Pathologic Processes
Therapeutic Uses
Antipruritics
Water-Electrolyte Imbalance
Ondansetron
Dermatologic Agents
Metabolic Diseases
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Digestive System Diseases
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Gastroenteritis
Central Nervous System Agents
Dehydration

ClinicalTrials.gov processed this record on February 08, 2010