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TRAUMEEL for Pain After Fracture of Neck of Femur
This study is not yet open for participant recruitment.
Study NCT00307905   Information provided by Shaare Zedek Medical Center
First Received: March 27, 2006   Last Updated: October 18, 2009   History of Changes

March 27, 2006
October 18, 2009
April 2010
June 2011   (final data collection date for primary outcome measure)
Cumulative 48-hour postoperative morphine consumption [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
Cumulative 48-hour postoperative morphine consumption
Complete list of historical versions of study NCT00307905 on ClinicalTrials.gov Archive Site
  • Secondary: AUC of NRS scores for first 48 hrs.; [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
  • AUC of NRS scores for days 14-17.; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
  • Composite measure of pain intensity and opiate consumption; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
  • Number of primary oral analgesic tablets ingested between days 14-17; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
  • ESR and hs-CPR at three and six days and six weeks; [ Time Frame: 42d ] [ Designated as safety issue: No ]
  • IL-6 at three and six days; [ Time Frame: 6d ] [ Designated as safety issue: No ]
  • Post operative blood loss; [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
  • WOMAC; [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
  • Safety of post operative treatment [ Time Frame: 17d ] [ Designated as safety issue: Yes ]
  • Secondary: AUC of NRS scores for first 48 hrs.;
  • AUC of NRS scores for days 14-17.;
  • Composite measure of pain intensity and opiate consumption;
  • Number of primary oral analgesic tablets ingested between days 14-17;
  • ESR and hs-CPR at three and six days and six weeks;
  • IL-6 at three and six days;
  • Post operative blood loss;
  • WOMAC;
  • Safety of post operative treatment
 
TRAUMEEL for Pain After Fracture of Neck of Femur
A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Post-operative Pain After Fracture of Neck of Femur

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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
  • Pain
  • Fracture of Neck of Femur
  • Drug: Traumeel S
  • Drug: Placebo remedy
  • Active Comparator: TRAUMEEL S
  • Placebo Comparator: placebo remedy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
224
 
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Menachem Oberbaum, MD 972-2-6666395 oberbaum@szmc.org.il
Israel
 
NCT00307905
Menachem Oberbaum, MD, Shaare Zedek Medical Center,
NoF 06 CTIL
Shaare Zedek Medical Center
 
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP