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A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.

Phase 3
18 Years
70 Years
Not Enrolling
Pain, Breast Diseases

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Trial Information

A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After 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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

VAS Scores.

Outcome Time Frame:

mean and daily

Safety Issue:


Principal Investigator

Alex D Mitchell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CDHA, Dalhousie University


Canada: Health Canada

Study ID:




Start Date:

May 2006

Completion Date:

September 2008

Related Keywords:

  • Pain
  • Breast Diseases
  • Randomized controlled trial
  • Clinical trial
  • Breast tumor surgery
  • Outpatient surgery
  • Analgesia
  • Outpatient analgesia
  • Post surgical analgesia
  • ≥ 18 and ≤ 70 years of age
  • Elective outpatient breast surgery for:
  • lumpectomy/quadrantectomy +/- Sentinel Lymph Node Biopsy
  • lumpectomy/quadrantectomy with Axillary Node Dissection
  • simple mastectomy +/- Sentinel Lymph Node Biopsy
  • Modified Radical mastectomy
  • Breast Diseases