Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
The majority of pediatric surgery takes place in an outpatient basis. The occurrence of
postoperative vomiting can lead to a delay in hospital discharge. However, the use of
postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects
and also raises the final costs of the surgical procedure. The Objective our study is Compare
the incidence of postoperative vomiting between children who received dexamethasone,
dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient
surgery. This is a randomized, double blind, placebo-controlled study to comparing the use of
dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting
prophylaxis in children submitted to general anesthesia. Data analysis will be used is
Fisher's exact test for the categorical variables and the Anova test for numerical variables
as they presented Gaussian variation. The study used a significance level of 5%.
Phase:
Phase 3
Details
Lead Sponsor:
Instituto Materno Infantil Prof. Fernando Figueira