TRAUMEEL for Pain After Fracture of Neck of Femur

Shaare Zedek Medical Center

Status and phase: Withdrawn; Phase 3

Conditions: Fracture of Neck of Femur; Pain

Treatments: Drug: Traumeel S; Drug: Placebo remedy

Study type: Interventional

Funder types: Other

Identifiers

NCT00307905

NoF 06 CTIL

Details and patient eligibility

About

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 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively. Immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses of morphine will be calculated based upon the patient's weight and current NRS, according to a preplanned scheme. Patients will be permitted to request additional morphine, beyond their calculated dose.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
• Age over 18 years.
• Signature upon informed consent form

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

TRAUMEEL S

Treatment:

Drug: Traumeel S

B

Placebo Comparator group

Description:

placebo remedy

Treatment:

Drug: Placebo remedy