Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-10-31
2014-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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tramadol infiltration
infiltration of tramadol 2mg/kg
Tramadol 2mg/kg
2mg/kg
Saline solution
Infiltration of saline
Saline solution
saline solution- 1 dose
Interventions
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Tramadol 2mg/kg
2mg/kg
Saline solution
saline solution- 1 dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* cancer,
* hepatic or renal alteration
4 Years
12 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Rioko Kimiko Sakata
Pain Clinic Director
Principal Investigators
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Rioko K Sakata
Role: STUDY_DIRECTOR
Universidade Federal de São Paulo
Locations
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Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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CEP2011
Identifier Type: -
Identifier Source: org_study_id
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