T3AI-Pain After Breast Surgery

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Scotia Health Authority
• Treatments: Acetaminophen; Codeine; Ibuprofen

Criteria

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.