Status:
COMPLETED
Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
Lead Sponsor:
Vejle Hospital
Collaborating Sponsors:
Norpharma A/S
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Effective treatment of pain after hip fractures is very important but difficult. It is often an old patient who has many adverse effects with the use of morphine. This is a randomized pilot study whe...
Eligibility Criteria
Inclusion
- Males and females age 18 years or more
- X-ray confirming basicervical, pertrochanteric or subtrochanteric femur fracture and planning operation with DHS or PFN.
- Subjects must have 7 or more points in the Hindsøes test.
Exclusion
- Subjects where spinal anaesthesia cannot be applied.
- Subject in Plavix® treatment seven days before admission to the hospital.
- Subjects with extracapsular hip fracture due to bone metastasis.
- Subjects with a BMI over 30.
- Subjects under 45 kg.
- Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior admission to the hospital.
- Substance or alcohol abuse, or subjects who, in the opinion of the investigator have demonstrated addictive or substance abuse behavior.
- Untreated depression or other psychiatric disorder in such a way that participation in the study may in the opinion of the investigator pos an unacceptable risk to the subject.
- Dermatological disorder at any relevant patch application site.
- Any contraindications listed in the Summary of Product Characteristics for Norspan®, OxyNorm® and OxyContin®.
- Patient does not tolerate oxynorm.
- User of wheelchair.
- Daily use of morphine before hospitalization.
- More than one fracture. Patients with myasthenia gravis. Patients with severe respiratory function. Patients know need re-operation women of childbearing potential must have a negative pregnancy test and be non-lactating
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00964808
Start Date
September 1 2009
End Date
August 1 2013
Last Update
December 8 2014
Active Locations (1)
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1
Orthopaedic Department
Vejle, Denmark, 7100