Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
Recruitment status was Recruiting
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 where the investigators want to compare Norspan plaster to Oxycontin tablets to patients with particular kind of hip fractures. The investigators will evaluate mobilization, pain, use of rescue medicine, adverse effects and length of stay. No clinical study about the effect of Norspan as acute painkiller has never been done before. Can the investigators get the patients mobilized earlier with less adverse effects?
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur|
- Mobilization measured daily using Cumulated Ambulation Score. [ Time Frame: 12 days ] [ Designated as safety issue: No ]
- Pain intensity measured daily on a verbal rating scale [ Time Frame: 12 days ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: 12 days + 14 days ] [ Designated as safety issue: No ]
- Opioid consumption. [ Time Frame: 12 days ] [ Designated as safety issue: No ]
- Length of stay in Hospital [ Time Frame: Untill discharge ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Double dummy; Group A: Active Buprenorphine and placebo oxycodone
Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.
Other Name: Norspan
Group B: Placebo Buprenorphine and Active Oxycodone
Start: 10 hours (+/- 2 hours) after the operation. Dosage: 10 mg * 2 pr. day until time to discharge from the Hospital or latest at day 12.
Other Name: Oxycontin
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964808
|Contact: Per Kjaersgaard-Andersen, MD||+45 firstname.lastname@example.org|
|Contact: Lena Schroll, MD||+45 email@example.com|
|Vejle, Denmark, 7100|
|Contact: Per Kjaersgaard-Andersen, MD +4579405716 firstname.lastname@example.org|
|Contact: Kirsten Specht, RN +4579405757 email@example.com|
|Principal Investigator: Per Kjaersgaard-Andersen, MD|
|Study Director:||Per Kjaersgaard-Andersen, MD||Orthopaedic Department, Vejle Hospital, Denmark|