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Anticipation of inadequate recruitment according to current format.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | TRAUMEEL S |
|
| B | Placebo Comparator | placebo remedy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traumeel S | Drug | homeopathic remedy |
| |
| Placebo remedy |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative 48-hour postoperative morphine consumption | 48h |
| Measure | Description | Time Frame |
|---|---|---|
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Menachem Oberbaum, MD | Shaare Zedek Medical Center, Jerusalem, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Orthopedic Surgery, Shaare Zedek Medical Center | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006620 | Hip Fractures |
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| ID | Term |
|---|---|
| C433370 | Traumeel S |
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| Drug |
identical size, shape and taste of treatment medication |
|
| 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 |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |