Status:
COMPLETED
T3AI-Pain After Breast Surgery
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Pain
Breast Diseases
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 analges...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- ages 18 to 70 inclusive
- outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00299039
Start Date
May 1 2006
End Date
September 1 2008
Last Update
February 2 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9