Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
Information source: Children's Hospitals and Clinics of Minnesota
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Condition(s) targeted: Dehydration; Gastroenteritis
Intervention: Ondansetron (Drug); Saline (Drug)
Sponsored by: Children's Hospitals and Clinics of Minnesota
Official(s) and/or principal investigator(s):
Sam Reid, MD, Principal Investigator, Affiliation: Children's Hospitals and Clinics of Minnesota
Henry Ortega, MD, Principal Investigator, Affiliation: Children's Hospitals and Clinics of Minnesota
Jeffrey Louie, MD, Principal Investigator, Affiliation: Children's Hospitals and Clinics of Minnesota
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
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 . 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
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
Official title: Ondansetron vs. Placebo in the Management of Children With Dehydration Due to Acute Gastroenteritis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Received further IV fluids
Minimum age: 6 Months.
Maximum age: 5 Years.
- 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
- Severe dehydration
- History of significant gastrointestinal, metabolic, renal or cardiac disorder
- Ondansetron allergy
- Non-English language proficient parent/guardian
- Parent/guardian has no telephone
Locations and Contacts
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.
Starting date: September 2008
Last updated: July 13, 2015