TRAUMEEL for Pain After Fracture of Neck of Femur
- Conditions
- PainFracture of Neck of Femur
- Interventions
- Drug: Traumeel SDrug: Placebo remedy
- Registration Number
- NCT00307905
- Lead Sponsor
- Shaare Zedek Medical Center
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 224
- Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
- Age over 18 years.
- Signature upon informed consent form
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Traumeel S TRAUMEEL S B Placebo remedy placebo remedy
- Primary Outcome Measures
Name Time Method Cumulative 48-hour postoperative morphine consumption 48h
- Secondary Outcome Measures
Name Time Method Secondary: AUC of NRS scores for first 48 hrs.; 48h AUC of NRS scores for days 14-17.; 17d Composite measure of pain intensity and opiate consumption; 17d Number of primary oral analgesic tablets ingested between days 14-17; 17d ESR and hs-CPR at three and six days and six weeks; 42d IL-6 at three and six days; 6d Post operative blood loss; 48h WOMAC; 17d Safety of post operative treatment 17d
Trial Locations
- Locations (1)
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel