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Trial record 14 of 74 for:    Codeine AND Acetaminophen

T3AI-Pain After Breast Surgery (T3AI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00299039
Recruitment Status : Completed
First Posted : March 6, 2006
Last Update Posted : February 2, 2009
Sponsor:
Information provided by:
Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE March 2, 2006
First Posted Date  ICMJE March 6, 2006
Last Update Posted Date February 2, 2009
Study Start Date  ICMJE May 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • VAS Scores. [ Time Frame: mean and daily ]
  • maximum VAS scores. [ Time Frame: daily ]
  • Likert scores. [ Time Frame: mean daily and final ]
  • Patient satisfaction with analgesic regimen. [ Time Frame: day 7 ]
  • Treatment failures-inadequate pain relief or inability to tolerate side effects. [ Time Frame: daily ]
  • Time to stopping medication. [ Time Frame: day 7 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2006)
  • Mean and daily VAS Scores.
  • Maximum daily VAS scores.
  • Mean daily and final Likert scores.
  • Patient satisfaction with analgesic regimen.
  • Treatment failures-inadequate pain relief or inability to tolerate side effects.
  • Time to stopping medication.
Change History Complete list of historical versions of study NCT00299039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2008)
  • Total Pain relief (TOTPAR). [ Time Frame: daily ]
  • Sum of pain intensity differences (SPID). [ Time Frame: day7 ]
  • Amount of medication used. [ Time Frame: day 7 ]
  • Incidence of side effects. [ Time Frame: day 7 ]
  • Compliance with regimen. [ Time Frame: day 7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2006)
  • Total Pain relief (TOTPAR).
  • Sum of pain intensity differences (SPID).
  • Amount of medication used.
  • Incidence of side effects.
  • Compliance with regimen.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE T3AI-Pain After Breast Surgery
Official Title  ICMJE A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery.
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 analgesic efficacy of acetaminophen plus ibuprofen against Tylenol #3® in patients undergoing outpatient breast surgery.
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Breast Diseases
Intervention  ICMJE
  • Drug: acetaminophen plus codeine
    capsules four times daily until pain free or for a maximum of seven days
  • Drug: acetaminophen plus ibuprofen
    capsules four times daily until pain free or for a maximum of seven days
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: acetaminophen plus codeine
  • Active Comparator: 2
    Intervention: Drug: acetaminophen plus ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 3, 2006)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00299039
Other Study ID Numbers  ICMJE CDHA008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Alex Mitchell, Dalhousie University
Study Sponsor  ICMJE Nova Scotia Health Authority
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex D Mitchell, MD CDHA, Dalhousie University
PRS Account Nova Scotia Health Authority
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP