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Tramadol Infiltration for Tonsillectomy

Primary Purpose

Postoperative Pain

Status

Withdrawn

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Tramadol 2mg/kg

Saline solution

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Tramadol infiltration, Analgesic effect, Serum IL-6

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

Exclusion Criteria:

coagulopathy,
cancer,
hepatic or renal alteration

Sites / Locations

Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

tramadol infiltration

Saline solution

Arm Description

infiltration of tramadol 2mg/kg

Infiltration of saline

Outcomes

Primary Outcome Measures

Analgesic effect

Secondary Outcome Measures

Full Information

NCT ID

NCT01636700

First Posted

July 5, 2012

Last Updated

July 27, 2015

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01636700

Brief Title

Tramadol Infiltration for Tonsillectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Withdrawn

Study Start Date

October 2011 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Tramadol infiltration, Analgesic effect, Serum IL-6

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tramadol infiltration

Arm Type

Active Comparator

Arm Description

infiltration of tramadol 2mg/kg

Arm Title

Saline solution

Arm Type

Placebo Comparator

Arm Description

Infiltration of saline

Intervention Type

Drug

Intervention Name(s)

Tramadol 2mg/kg

Other Intervention Name(s)

Opioid

Intervention Description

2mg/kg

Intervention Type

Drug

Intervention Name(s)

Saline solution

Other Intervention Name(s)

Placebo

Intervention Description

saline solution- 1 dose

Primary Outcome Measure Information:

Title

Analgesic effect

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy Exclusion Criteria: coagulopathy, cancer, hepatic or renal alteration

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rioko K Sakata

Organizational Affiliation

Universidade Federal de São Paulo

Official's Role

Study Director

Facility Information:

Facility Name

Universidade Federal de São Paulo

City

São Paulo

ZIP/Postal Code

04044020

Country

Brazil

12. IPD Sharing Statement

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Tramadol Infiltration for Tonsillectomy

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