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

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

MedlinePlus related topics:

Gastroenteritis Nausea and Vomiting

ChemIDplus related topics:

Sodium chloride Ondansetron Ondansetron hydrochloride

U.S. FDA Resources

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

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:	July 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

Contacts


Contact: Laurie Blumberg-Romero	612-813-7628	laurie.blumberg-romero@childrensmn.org

Locations


United States, Minnesota
	Children's Hospitals and Clinics of Minnesota	Not yet recruiting
	St. Paul, Minnesota, United States, 55102
	Contact: Sam Reid, MD 651-220-6914 sam.reid@childrensmn.org

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:	Children's Hospitals and Clinics of Minnesota ( Sam Reid, MD )
Study ID Numbers:	0801-012
First Received:	June 3, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00691275
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:

dehydration

acute gastroenteritis

ondansetron

rehydration

Study placed in the following topic categories:

Digestive System Diseases

Metabolic Diseases

Gastrointestinal Diseases

Water-Electrolyte Imbalance

Ondansetron

Metabolic disorder

Gastroenteritis

Serotonin

Dehydration

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Gastrointestinal Agents

Central Nervous System Depressants

Antiemetics

Antipsychotic Agents

Pharmacologic Actions

Serotonin Antagonists

Pathologic Processes

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Antipruritics

Anti-Anxiety Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Children's Hospitals and Clinics of Minnesota
Information provided by:	Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:	NCT00691275