Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

Dehydration Clinical Trial

Official title:

Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00691275
• Other study ID #: 0801-012
• Status: Withdrawn
• Phase: N/A
• First received: June 3, 2008
• Last updated: July 13, 2015
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: July 2015
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehydration
• Gastroenteritis

Intervention

Drug:
• Ondansetron

• Saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

References & Publications (5)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Received further IV fluids		2-7 days post discharge	No