A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.
18 Years
70 Years
Both
Pain, Breast Diseases
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:
Interventional
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:
No
Principal Investigator
Alex D Mitchell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
CDHA, Dalhousie University
Authority:
Canada: Health Canada
Study ID:
CDHA008
NCT ID:
NCT00299039
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
Name | Location |
|---|
