A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.
Block randomization will be used to randomize patients to one of two combinations. Group A
will receive capsules containing 650 mg Acetaminophen plus 400 mg Ibuprofen. Group B will
receive capsules containing 600 mg Acetaminophen, 15 mg caffeine and 60 mg codeine. Capsules
are placed in identical dossettes containing a seven day supply. Patients are instructed to
start taking their medications post-op and continue until they are pain free. All
participants are given a series of blank Visual Analogue scales and Likert scales and
instructed to record their level of pain intensity and pain relief four times per day for
the entire week. Peri-operative pain management will be standardized. Patients will not
receive pre-operative analgesics. Intra-operative analgesia will be intravenous opioids as
selected by anaesthesiology. No local/regional anaesthesia will be used. Intravenous
ketorolac will not be allowed for trial participants. All patients will receive intravenous
opioid and anti-emetic if required in PACU. Any patients with peri-operative complications
or other problems requiring admission or alternative analgesics will be excluded.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
VAS Scores.
mean and daily
No
Alex D Mitchell, MD
Principal Investigator
CDHA, Dalhousie University
Canada: Health Canada
CDHA008
NCT00299039
May 2006
September 2008
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