Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration - Full Text View

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:	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:

MedlinePlus related topics: Gastroenteritis Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron

U.S. FDA Resources

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

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:

Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705.

Reeves JJ, Shannon MW, Fleisher GR. Ondansetron decreases vomiting associated with acute gastroenteritis: a randomized, controlled trial. Pediatrics. 2002 Apr;109(4):e62.

Ramsook C, Sahagun-Carreon I, Kozinetz CA, Moro-Sutherland D. A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis. Ann Emerg Med. 2002 Apr;39(4):397-403.

Stork CM, Brown KM, Reilly TH, Secreti L, Brown LH. Emergency department treatment of viral gastritis using intravenous ondansetron or dexamethasone in children. Acad Emerg Med. 2006 Oct;13(10):1027-33. Epub 2006 Aug 10.

Reid SR, Bonadio WA. Outpatient rapid intravenous rehydration to correct dehydration and resolve vomiting in children with acute gastroenteritis. Ann Emerg Med. 1996 Sep;28(3):318-23.

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:

Dehydration
Gastroenteritis
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
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 February 09, 2012