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

NCT01297010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2011-08-03

No results posted yet for this study

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%.

Conditions

  • Vomiting Postoperative

Interventions

DRUG

Dexamethasone and ondasetron

Patients will receive ondansetron (0.1 mg / kg dose of 4mg cap) associated with dexamethasone (0.15 mg / kg dose of 5mg ceiling) or dexamethasone (0.15 mg / kg) or placebo

DRUG

Dexamethasone

Children were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling)

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    collaborator OTHER

  • Instituto Materno Infantil Prof. Fernando Figueira

    lead OTHER

Principal Investigators

  • Flavia Orange, Investigator · Universidade Federal de Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-07-31
Completion
2011-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297010 on ClinicalTrials.gov