drugset / Trial / NCT01297010

Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children

NCT01297010

RandomizedFactorialDouble-blindPrevention

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%.

Timeline

Start
2011-03
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.15 mg/kg
Comparator Ondansetron Other / unclassified 0.1 mg/kg

Indications

No indication recorded.