Status:
COMPLETED
Safety and Tolerability of Controlled-release Oxycodone on Postoperative Pain in Oncologic Head and Neck Surgery
Lead Sponsor:
Instituto Nacional de Cancer, Brazil
Conditions:
Postoperative Nausea
Adverse Effects
Eligibility:
All Genders
18-70 years
Brief Summary
The hypothesis of this study is that controlled release oxycodone can be safe and well tolerated for the control of postoperative pain in surgery for head and neck cancer. The primary objective is to ...
Detailed Description
Phase IV clinical trial, observational, prospective, open approved by the Research Ethics Committee of the National Cancer Institute José Alencar Gomes da Silva - INCA, Brazil (no. 10/2010). The Instr...
Eligibility Criteria
Inclusion
- patients on postoperative head and neck oncologic surgery
- 2 and 3 American Society of Anesthesiologists physical status
- moderate to severe postoperative pain
- elective surgery
- able to swallow tablets whole (not chewed, broken or crushed) in the immediate postoperative period after recovery of cognitive functions.
Exclusion
- pregnant or breastfeeding
- allergic to oxycodone and other opioids
- gastrectomized or colostomized
- asthmatics with severe organ dysfunction
- history or suspected paralytic ileus
- history psychiatric disorders
- severe respiratory depression
- patients who are receiving opioid analgesics in baseline
- history of abuse of alcohol and illicit drugs
- plasma glutamic oxaloacetic transaminase above 48 U / l (men) and 40 U / I (women) and / or glutamic pyruvic transaminase above 53 U / l (men) and 40 U / I (women)
- plasma creatinine above 1.7 mg / dl and / or urea above 65 mg / dl
- emergency surgery
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01834898
Start Date
October 1 2010
End Date
October 1 2012
Last Update
April 18 2013
Active Locations (1)
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1
Instituto Nacional de Câncer José Alencar Gomes da Silva
Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130