Status:
WITHDRAWN
TRAUMEEL for Pain After Fracture of Neck of Femur
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Pain
Fracture of Neck of Femur
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip. 224 pa...
Eligibility Criteria
Inclusion
- Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
- Age over 18 years.
- Signature upon informed consent form
Exclusion
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Refused to give verbal consent to the telephone interviews
- Impossibility to be reached during the 14-17 days post operative
- Inability to comply with the study protocol for any other reason
- Previous major surgical procedure on ipsilateral hip.
- Current use of analgesics for any other reason.
- A history of chronic pain syndrome.
- Abused legal or illicit drug use.
- Hypersensitivity to botanicals of the Compositae family
- Known sensitivity to paracetamol, codeine or tramadol.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00307905
Start Date
January 1 2011
Last Update
October 29 2010
Active Locations (1)
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1
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel