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

This study has been completed.
Sponsor:
Collaborator:
Universidade Federal de Pernambuco
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT01297010
First received: February 15, 2011
Last updated: August 2, 2011
Last verified: July 2011
  Purpose

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%.


Condition Intervention Phase
Vomiting Postoperative
Drug: Dexamethasone and ondasetron
Drug: Dexamethasone
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 134
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297010

Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Universidade Federal de Pernambuco
Investigators
Principal Investigator: Flavia Orange, Investigator Universidade Federal de Pernambuco
  More Information

No publications provided

Responsible Party: Flavia Orange, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT01297010     History of Changes
Other Study ID Numbers: 231/10
Study First Received: February 15, 2011
Last Updated: August 2, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Nausea and Vomiting
Vomiting
Postoperative
Anesthesia

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ondansetron
Anti-Anxiety Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014