Clinical trial · Interventional
T3AI-Pain After Breast Surgery
A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.
NCT00299039CI-TRIAL-00001957T3AIcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Diseases | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| acetaminophen plus codeine | Drug | — | UNRESOLVED |
| acetaminophen plus ibuprofen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: acetaminophen plus codeine
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Drug: acetaminophen plus ibuprofen
Primary outcomes (6)
- measure
- VAS Scores.
- timeFrame
- mean and daily
- measure
- maximum VAS scores.
- timeFrame
- daily
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.