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Tramadol Infiltration for Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01636700
Recruitment Status : Withdrawn
First Posted : July 10, 2012
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo

Tracking Information
First Submitted Date  ICMJE July 5, 2012
First Posted Date  ICMJE July 10, 2012
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2012)
Analgesic effect [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01636700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tramadol Infiltration for Tonsillectomy
Official Title  ICMJE Comparative Study of Analgesic Effect and Serum IL-6 With Tramadol Infiltration or Intravenous After Tonsillectomy
Brief Summary The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.
Detailed Description

The study will be prospective, double-blind, randomized study of 40 children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy under general anesthesia.

Patients will be allocated into two groups. Group 1 patients will receive tramadol 2 mg / kg intravenously and saline 0.9% infiltration in tonsils; group 2, will receive tramadol 2 mg / kg infiltration and intravenous saline.

There will be evaluated: postoperative pain intensity by facial scale, supplementary analgesics and interleukin-6. For statistical analysis of the results will be used parametric and nonparametric tests, taking into account the nature of the variables. The level of statistical significance will be set at < 0.05.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Tramadol 2mg/kg
    2mg/kg
    Other Name: Opioid
  • Drug: Saline solution
    saline solution- 1 dose
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: tramadol infiltration
    infiltration of tramadol 2mg/kg
    Intervention: Drug: Tramadol 2mg/kg
  • Placebo Comparator: Saline solution
    Infiltration of saline
    Intervention: Drug: Saline solution
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2012)
40
Estimated Study Completion Date  ICMJE October 2014
Estimated Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

Exclusion Criteria:

  • coagulopathy,
  • cancer,
  • hepatic or renal alteration
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01636700
Other Study ID Numbers  ICMJE CEP2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rioko Kimiko Sakata, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rioko K Sakata Universidade Federal de São Paulo
PRS Account Federal University of São Paulo
Verification Date February 2014

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