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TRAUMEEL for Pain After Fracture of Neck of Femur

This study has been withdrawn prior to enrollment.
(Anticipation of inadequate recruitment according to current format.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307905
First Posted: March 28, 2006
Last Update Posted: October 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  Purpose

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.


Condition Intervention Phase
Pain Fracture of Neck of Femur Drug: Traumeel S Drug: Placebo remedy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Cumulative 48-hour postoperative morphine consumption [ Time Frame: 48h ]

Secondary Outcome Measures:
  • Secondary: AUC of NRS scores for first 48 hrs.; [ Time Frame: 48h ]
  • AUC of NRS scores for days 14-17.; [ Time Frame: 17d ]
  • Composite measure of pain intensity and opiate consumption; [ Time Frame: 17d ]
  • Number of primary oral analgesic tablets ingested between days 14-17; [ Time Frame: 17d ]
  • ESR and hs-CPR at three and six days and six weeks; [ Time Frame: 42d ]
  • IL-6 at three and six days; [ Time Frame: 6d ]
  • Post operative blood loss; [ Time Frame: 48h ]
  • WOMAC; [ Time Frame: 17d ]
  • Safety of post operative treatment [ Time Frame: 17d ]

Estimated Enrollment: 224
Study Start Date: January 2011
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
TRAUMEEL S
Drug: Traumeel S
homeopathic remedy
Placebo Comparator: B
placebo remedy
Drug: Placebo remedy
identical size, shape and taste of treatment medication

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307905


Locations
Israel
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, MD Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

Responsible Party: Menachem Oberbaum, MD, Shaare Zedek Medical Center,
ClinicalTrials.gov Identifier: NCT00307905     History of Changes
Other Study ID Numbers: NoF 06 CTIL
First Submitted: March 27, 2006
First Posted: March 28, 2006
Last Update Posted: October 29, 2010
Last Verified: October 2010

Keywords provided by Shaare Zedek Medical Center:
homeopathy
pain
traumeel s
Fracture of neck of femur
Surgical correction of fracture of neck of hip

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries