Tramadol Infiltration for Tonsillectomy
The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparative Study of Analgesic Effect and Serum IL-6 With Tramadol Infiltration or Intravenous After Tonsillectomy|
- Analgesic effect [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: tramadol infiltration
infiltration of tramadol 2mg/kg
Drug: Tramadol 2mg/kg
Other Name: Opioid
Placebo Comparator: Saline solution
Infiltration of saline
Drug: Saline solution
saline solution- 1 dose
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636700
|Universidade Federal de São Paulo||Recruiting|
|São Paulo, Brazil, 04044020|
|Contact: Simone H Derzi, MD 55 11 50847463 firstname.lastname@example.org|
|Sub-Investigator: Plinio C Leal, MD|
|Study Director:||Rioko K Sakata||Universidade Federal de São Paulo|