Status:
COMPLETED
OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain
Lead Sponsor:
Odense University Hospital
Conditions:
Postoperative Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Patients undergoing surgery (thyroidectomy and hysterectomy) will postoperatively receive oxycodone intravenously (IV) as pain management with morphine as an escape medicine, if there is insufficient ...
Detailed Description
Oxycodone is a semi-synthetic opioid with an analgesic effect in the postoperative pain management comparable to morphine. Oxycodone is N-demethylated by CYP2D6 to its active metabolite oxymorphone, a...
Eligibility Criteria
Inclusion
- Ages 18-80 years old
- Caucasian race
- Signed informed consent
- Patients admitted for one of the following operations: thyroidectomy, mastectomy, hysterectomy, mammaexpander operation, nasal septum correction and jaw operations.
Exclusion
- Allergy towards oxycodone
- Previous daily opioid use
- Known severe illness (terminal cancer, severe dementia, uncompensated heart failure, kidney failure, liver failure and severe lung failure)
- Lack of ability to use patient controlled analgesia or to follow the trial protocol
- Pregnancy
- Severe psychiatric illness
- Alcoholism
- Ongoing treatment with potent CYP2D6 inhibitors (fluoxetine, paroxetine and terbinafine)
- Severe perioperative complications or re-operation within the first 24 hours
- Use of extra pain management during the anaesthesia with an effect after the operation
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00260260
Start Date
June 1 2005
End Date
December 1 2007
Last Update
January 11 2008
Active Locations (1)
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1
Odense University Hospital
Odense C, Odense, Denmark, DK-5000