TRAUMEEL for Pain After Fracture of Neck of Femur

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00307905
• Other study ID #: NoF 06 CTIL
• Status: Withdrawn
• Phase: Phase 3
• First received: March 27, 2006
• Last updated: October 28, 2010
• Start date: January 2011

Study information

• Verified date: October 2010
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 224
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fracture of Neck of Femur
• Fractures, Bone
• Pain

Intervention

Drug:
• Traumeel S
homeopathic remedy
• Placebo remedy
identical size, shape and taste of treatment medication

Locations

Country	Name	City	State
Israel	Dept. of Orthopedic Surgery, Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative 48-hour postoperative morphine consumption		48h	Yes
Secondary	Secondary: AUC of NRS scores for first 48 hrs.;		48h	Yes
Secondary	AUC of NRS scores for days 14-17.;		17d	Yes
Secondary	Composite measure of pain intensity and opiate consumption;		17d	Yes
Secondary	Number of primary oral analgesic tablets ingested between days 14-17;		17d	Yes
Secondary	ESR and hs-CPR at three and six days and six weeks;		42d	No
Secondary	IL-6 at three and six days;		6d	No
Secondary	Post operative blood loss;		48h	Yes
Secondary	WOMAC;		17d	Yes
Secondary	Safety of post operative treatment		17d	Yes