Tramadol Infiltration for Tonsillectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Rioko Kimiko Sakata, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01636700
First received: July 5, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Postoperative Pain
Drug: Tramadol 2mg/kg
Drug: Saline solution

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Analgesic effect [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
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)
Arms Assigned Interventions
Active Comparator: tramadol infiltration
infiltration of tramadol 2mg/kg
Drug: Tramadol 2mg/kg
2mg/kg
Other Name: Opioid
Placebo Comparator: Saline solution
Infiltration of saline
Drug: Saline solution
saline solution- 1 dose
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy

Exclusion Criteria:

  • coagulopathy,
  • cancer,
  • hepatic or renal alteration
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636700

Locations
Brazil
Universidade Federal de São Paulo Recruiting
São Paulo, Brazil, 04044020
Contact: Simone H Derzi, MD    55 11 50847463    simone_derzi@hotmail.com   
Sub-Investigator: Plinio C Leal, MD         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Rioko K Sakata Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Rioko Kimiko Sakata, Pain Clinic Director, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01636700     History of Changes
Other Study ID Numbers: CEP2011
Study First Received: July 5, 2012
Last Updated: February 24, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Tramadol infiltration
Analgesic effect
Serum IL-6

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Pharmaceutical Solutions
Tramadol
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014