Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled (vomiting)

NCT01297010 Phase 3 COMPLETED

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%.

Details

Lead sponsor	Instituto Materno Infantil Prof. Fernando Figueira
Phase	Phase 3
Status	COMPLETED
Enrolment	134
Start date	2011-03
Completion	2011-07

Conditions

• Vomiting Postoperative

Interventions

• Dexamethasone and ondasetron
• Dexamethasone

Primary outcomes

• Postoperative vomiting — The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone
  Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.