Postoperative Pain
Conditions
Keywords
Tramadol infiltration, Analgesic effect, Serum IL-6
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.
Interventions
DRUGTramadol 2mg/kg
2mg/kg
DRUGSaline solution
saline solution- 1 dose
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy
Exclusion criteria
* coagulopathy, * cancer, * hepatic or renal alteration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analgesic effect | 24 hours |
Countries
Brazil
Outcome results
None listed