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

Detailed Description:

The investigators know that a large number of pediatric surgeries are performed on an outpatient basis and the occurrence of nausea and vomiting after surgery can lead to delayed discharge and increased hospital costs. Based on this fact, the investigators find it relevant to determine the incidence of postoperative vomiting in pediatric surgery patients to assess the need for antiemetic prophylaxis in this study population being developed in the surgical ward of the Hospital das Clinicas - Federal University of Pernambuco (HC-UFPE ).

The study will be conducted from March 2011 to September 2011.Pacientes pediatric ASA I and II underwent surgery in the pediatric surgical ward of the HC-UFPE.

The sample size calculation was performed in the program StatCalc Epi-Info 6.04d, based on data from relevant literature and determined the presence of 44 patients in each of the three groups, totaling 132 patients in the study.

Patients will be recruited in the preparation room anesthetic in surgical clinics of the Hospital for three shifts of existing pediatric surgery. After evaluation of each patient and then filled the criteria of inclusion and exclusion, those responsible will be informed about the procedures being undertaken and the possible consequences of their participation in research.

Only after signing an informed consent by the person responsible will be held the allocation of patients into three groups, after opening the sealed envelope containing the selected group for that participant. These envelopes are previously prepared by a person outside the research.

Therefore, the researcher has no prior knowledge of the group selected for the participant at the time of the consent solicitation.

At the end of the study will fill a flowchart with the profile of the trial, including the total number of patients, the number of eligible patients, the number of those who were offered participation in the study, the number of denied and his reason the number of patients who agreed to participate. The latter will be known only after statistical analysis Randomization to each specific group will be held in accordance with a table of random numbers previously generated computer (Random Allocation Software 1.0, 2004).

Independent variable

  • Use of dexamethasone and ondansetron, or dexamethasone or placebo only

Dependent Variables

  • Incidence of postoperative vomiting;
  • The need for antiemetic therapy in the recovery room post-anesthesia unit (PACU)
  • Length of stay in PACU
  • Delaying Hospital discharge All patients and their caregivers will be duly informed of the research objectives and will be included in the study only if they agree to participate and sign the Deed of Consent. The project was designed following the recommendations of Resolution 196/96 of the National Health Council and the Declaration of Helsinki for research involving human subjects (2000). In addition, the project was submitted to the Ethics Committee of the Hospital das Clinicas-UFPE and approved.

Patients will receive all information regarding the advantages and disadvantages of this technique, being safeguarded the right to refuse to participate. The researchers will undertake to publish the study, regardless of the outcome.

  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
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Dexamethasone acetate
Dexamethasone
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics

ClinicalTrials.gov processed this record on July 20, 2014