Current standard of care for post-operative analgesia after breast surgery in CDHA is Tylenol #3® (300 mg acetaminophen, 30 mg codeine, 15 mg caffeine per tablet). We are proposing to test the analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
capsules four times daily until pain free or for a maximum of seven days
capsules four times daily until pain free or for a maximum of seven days
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
VAS Scores.
Time frame: mean and daily
maximum VAS scores.
Time frame: daily
Likert scores.
Time frame: mean daily and final
Patient satisfaction with analgesic regimen.
Time frame: day 7
Treatment failures-inadequate pain relief or inability to tolerate side effects.
Time frame: daily
Time to stopping medication.
Time frame: day 7
Total Pain relief (TOTPAR).
Time frame: daily
Sum of pain intensity differences (SPID).
Time frame: day7
Amount of medication used.
Time frame: day 7
Incidence of side effects.
Time frame: day 7
Compliance with regimen.
Time frame: day 7
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