Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307905
Status:
WITHDRAWN
Last Update Posted:
2010-10-29
First Post:
2006-03-27
Brief Title:
TRAUMEEL for Pain After Fracture of Neck of Femur
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Anticipation of inadequate recruitment according to current format
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 01mgkg 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 patients weight and current NRS according to a preplanned scheme Patients will be permitted to request additional morphine beyond their calculated dose
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 01mgkg 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 patients weight and current NRS according to a preplanned scheme Patients will be permitted to request additional morphine beyond their calculated dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None