Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
Status:
Withdrawn
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
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.