Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur
|ClinicalTrials.gov Identifier: NCT00964808|
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : December 8, 2014
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?
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Buprenorphine Drug: Oxycodone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2013|
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
- Mobilization measured daily using Cumulated Ambulation Score. [ Time Frame: 12 days ]
- Pain intensity measured daily on a verbal rating scale [ Time Frame: 12 days ]
- Adverse effects [ Time Frame: 12 days + 14 days ]
- Opioid consumption. [ Time Frame: 12 days ]
- Length of stay in Hospital [ Time Frame: Untill discharge ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964808
|Vejle, Denmark, 7100|
|Study Director:||Per Kjaersgaard-Andersen, MD||Orthopaedic Department, Vejle Hospital, Denmark|