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

NCT01297010 | Completed Phase 3 DMC

• 1 other identifier: 231/10
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Nausea and Vomiting; Vomiting; Postoperative; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Postoperative vomiting

  Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.

  The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone

Secondary Outcomes (1)

• delayed discharge

  In-room post-anesthesia recovery

Study Arms (2)

Dexamethasone

PLACEBO COMPARATOR

Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg) at the beginning of the procedure.

Drug: Dexamethasone

Dexamethasone and ondasetron

PLACEBO COMPARATOR

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

Interventions

Dexamethasone and ondasetron DRUG

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

Also known as: Decadron and nausedron

Dexamethasone and ondasetron

Dexamethasone DRUG

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

Also known as: Decadron

Dexamethasone

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I or II
• Patients aged between 1 and 10 years old
• Patients undergoing general anesthesia for surgical repair of hernia, cryptorchidism and phimosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead
• Universidade Federal de Pernambuco: collaborator

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Flavia Orange, Investigator

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-07