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