Tramadol Infiltration for Tonsillectomy
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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 |
- Analgesic effect [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (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 |
Inclusion Criteria:
- children aged ≥ 4 and ≤ 12 years undergoing tonsillectomy
Exclusion Criteria:
- coagulopathy,
- cancer,
- hepatic or renal alteration
Contacts and 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 | |
| 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: | March 11, 2013 |
| 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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms Analgesics Tramadol Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013