• VAS Scores. [ Time Frame: mean and daily ] [ Designated as safety issue: No ]
• maximum VAS scores. [ Time Frame: daily ] [ Designated as safety issue: No ]
• Likert scores. [ Time Frame: mean daily and final ] [ Designated as safety issue: No ]
• Patient satisfaction with analgesic regimen. [ Time Frame: day 7 ] [ Designated as safety issue: No ]
• Treatment failures-inadequate pain relief or inability to tolerate side effects. [ Time Frame: daily ] [ Designated as safety issue: No ]
• Time to stopping medication. [ Time Frame: day 7 ] [ Designated as safety issue: No ]

• Mean and daily VAS Scores.
• Maximum daily VAS scores.
• Mean daily and final Likert scores.
• Patient satisfaction with analgesic regimen.
• Treatment failures-inadequate pain relief or inability to tolerate side effects.
• Time to stopping medication.

• Total Pain relief (TOTPAR). [ Time Frame: daily ] [ Designated as safety issue: No ]
• Sum of pain intensity differences (SPID). [ Time Frame: day7 ] [ Designated as safety issue: No ]
• Amount of medication used. [ Time Frame: day 7 ] [ Designated as safety issue: No ]
• Incidence of side effects. [ Time Frame: day 7 ] [ Designated as safety issue: No ]
• Compliance with regimen. [ Time Frame: day 7 ] [ Designated as safety issue: No ]

• Total Pain relief (TOTPAR).
• Sum of pain intensity differences (SPID).
• Amount of medication used.
• Incidence of side effects.
• Compliance with regimen.

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.

• Pain
• Breast Diseases

• Drug: acetaminophen plus codeine
  capsules four times daily until pain free or for a maximum of seven days
• Drug: acetaminophen plus ibuprofen
  capsules four times daily until pain free or for a maximum of seven days

• 1: Active Comparator
  Intervention: Drug: acetaminophen plus codeine
• 2: Active Comparator
  Intervention: Drug: acetaminophen plus ibuprofen

Inclusion Criteria:

• ages 18 to 70 inclusive
• outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.

Exclusion Criteria:

• allergies to acetaminophen, NSAIDs, ASA or codeine.
• asthma.
• recent reported history of upper GI bleeding.
• daily analgesic use (OTC or opioid) pre-operatively.
• any opioid use in the week prior to surgery.
• reported history of PUD if not on PPI regularly.
• anticoagulant use (low dose ASA excepted).
• renal disease or impairment.
• reported history of liver disease.
• pregnancy.
• major operative complications.
• patients requiring admission.
• communication barrier.
• cognitive or memory impairment.
• reported history of drug and/or alcohol abuse.