Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children
Condition: Vomiting Postoperative
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

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%.
    

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.
    

Intervention name(s): Dexamethasone and ondasetron; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 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; Children were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling)
Other intervention name(s): Decadron and nausedron; Decadron
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Nausea and Vomiting; Vomiting; Postoperative; Anesthesia