Tramadol Infiltration for Tonsillectomy

Federal University of São Paulo

Status: Withdrawn

Conditions: Postoperative Pain

Treatments: Drug: Saline solution; Drug: Tramadol 2mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT01636700

CEP2011

Details and patient eligibility

About

The purpose of this study is to evaluate the analgesic effect and IL-6 after tramadol infiltration or intravenous for tonsillectomy.

Full 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.

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

Exclusion criteria

• coagulopathy,
• cancer,
• hepatic or renal alteration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

tramadol infiltration

Active Comparator group

Description:

infiltration of tramadol 2mg/kg

Treatment:

Drug: Tramadol 2mg/kg

Saline solution

Placebo Comparator group

Description:

Infiltration of saline

Treatment:

Drug: Saline solution