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Tramadol Infiltration for Tonsillectomy

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ClinicalTrials.gov Identifier: NCT01636700
Recruitment Status : Withdrawn
First Posted : July 10, 2012
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):

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.

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : October 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
Drug Information available for: Tramadol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: February 2014

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