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Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur

NCT00964808 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2014-12-08

No results posted yet for this study

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 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?

Conditions

  • Pain, Postoperative

Interventions

DRUG

Buprenorphine

Start: Day 0 (T=0), 10 micrograms/t until the day of discharge from the Hospital. New plaster at T= 7 days.

DRUG

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.

Sponsors & Collaborators

  • Norpharma A/S

    collaborator INDUSTRY

  • Vejle Hospital

    lead OTHER

Principal Investigators

  • Per Kjaersgaard-Andersen, MD · Orthopaedic Department, Vejle Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-05-31
Completion
2013-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00964808 on ClinicalTrials.gov