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

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ClinicalTrials.gov Identifier: NCT01297010
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : August 3, 2011
Sponsor:
Collaborator:
Universidade Federal de Pernambuco
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira

Tracking Information
First Submitted Date  ICMJE February 15, 2011
First Posted Date  ICMJE February 16, 2011
Last Update Posted Date August 3, 2011
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Postoperative vomiting [ Time Frame: The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone ]
Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
delayed discharge [ Time Frame: In-room post-anesthesia recovery ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children
Official Title  ICMJE Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled
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%.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Vomiting Postoperative
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Dexamethasone
  • 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.
    Intervention: Drug: Dexamethasone and ondasetron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2011)
134
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01297010
Other Study ID Numbers  ICMJE 231/10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Flavia Orange, Instituto Materno Infantil Prof. Fernando Figueira
Study Sponsor  ICMJE Instituto Materno Infantil Prof. Fernando Figueira
Collaborators  ICMJE Universidade Federal de Pernambuco
Investigators  ICMJE
Principal Investigator: Flavia Orange, Investigator Universidade Federal de Pernambuco
PRS Account Instituto Materno Infantil Prof. Fernando Figueira
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP