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Tramadol Infiltration for Tonsillectomy

This study has been withdrawn prior to enrollment.
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: July 27, 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 Rioko Kimiko Sakata, Federal University of São Paulo:

Primary Outcome Measures:
  • Analgesic effect [ Time Frame: 24 hours ]

Enrollment: 0
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   (Child)
Sexes Eligible for Study:   All
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
São Paulo, Brazil, 04044020
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Rioko K Sakata Universidade Federal de São Paulo
  More Information

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: July 27, 2015

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

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

ClinicalTrials.gov processed this record on August 16, 2017