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...
Date First Received: June 3, 2008
Last Updated: March 19, 2009
Verified by: Children's Hospitals and Clinics of Minnesota, March 2009
Clinical Trial Phase: N/A | Start Date: September 2008
Overall Status: Recruiting
Estimated Enrollment: 198
Brief Summary
Official Title: “Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Study Primary Completion Date: September 2009
Intervention(s) in this Clinical Trial
- Drug: Ondansetron
- Drug: Saline
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: 2
- Saline
- Active Comparator: 1
- Zofran
Outcome Measures for this Clinical Trial
Primary Measures
- Received further IV fluids
- Time Frame: 2-7 days post discharge
Safety Issue?: No
- Time Frame: 2-7 days post discharge
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Months
Maximum Age for this Clinical Trial: 5 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Children's Hospitals and Clinics of Minnesota
Overall Clinical Trial Officials and Contacts
Sam Reid, MD Principal Investigator Children's Hospitals and Clinics of Minnesota
Overall Contact: Laurie Blumberg-Romero 612-813-7628 laurie.blumberg-romero@childrensmn.org
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00691275
Study ID Number: 0801-012
ClinicalTrials.gov Identifier: NCT00691275
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
