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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira
• Collaborator: Universidade Federal de Pernambuco
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Ondansetron

Criteria

Inclusion Criteria:

• ASA I or II

• Patients aged between 1 and 10 years old

• Patients undergoing general anesthesia for surgical repair of hernia, cryptorchidism and phimosis

Exclusion Criteria:

• Officials who refused to sign the consent form

• ASA ≥ III

• History of allergy to dexamethasone and/or ondansetron

• Patients taking opioids preoperatively

• Patients using antiemetic drugs preoperatively

• Patients with vomiting preoperatively