OXY-1: The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain

NCT00260260 | Completed Phase 4

• 1 other identifier: EudraCT 2005-001145-42
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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 pain relief with oxycodone. Patients' pain and side effects will be registered and after 24 hours they will answer a questionnaire. All included patients will be genotyped accordingly to CYP2D6 and relevant single nucleotide polymorphisms (SNPs), and measures of plasma levels of oxycodone will be performed.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• Responder (satisfaction with pain treatment in questionnaire and no escape medication)

• Non-responder (dissatisfaction with pain management in questionnaire and/or escape medication)

• Responder status compared to CYP2D6 genotype

Secondary Outcomes (1)

• Registration of pain, side effects and total amount of oxycodone given compared to CYP2D6 genotype and SNPs

Interventions

Oxycodone DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, Odense, DK-5000, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Stine T. Zwisler, Dr.

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 30, 2005
• First Posted: December 1, 2005
• Study Start: June 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 11, 2008

Record last verified: 2008-01

Locations

DK (1)