Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children (vomiting)
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%.
Drug: Dexamethasone and ondasetron
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled|
- Postoperative vomiting [ Time Frame: The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone ] [ Designated as safety issue: Yes ]Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.
- delayed discharge [ Time Frame: In-room post-anesthesia recovery ] [ Designated as safety issue: Yes ]
- Determine the relationship between the incidence of vomiting and the presence or absence of risk factors (duration ≥ 30 minutes of surgery, age ≥ 3 years and positive history in their own or relatives of postoperative vomiting).
- To determine the association between pain in the immediate postoperative period and the incidence of postoperative vomiting
- To determine the association between postoperative vomiting and delayed discharge
|Study Start Date:||March 2011|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Dexamethasone
Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg) at the beginning of the procedure.
Children were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling)
Other Name: Decadron
Placebo Comparator: Dexamethasone and ondasetron
Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling) and ondansetron (0.1 mg / kg dose of 4mg ceiling)at the beginning of the procedure.
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
Other Name: Decadron and nausedron
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01297010
|Principal Investigator:||Flavia Orange, Investigator||Universidade Federal de Pernambuco|