NCT01636700

Tramadol Infiltration for Tonsillectomy

Comparative Study of Analgesic Effect and Serum IL-6 With Tramadol Infiltration or Intravenous After Tonsillectomy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Tramadol 2mg/kg	2mg/kg
DRUG	Saline solution	saline solution- 1 dose

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2012-07-10
• Last updated: 2015-07-28

Locations

1 site across 1 country: Brazil