NCT00299039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started May 2006

Typical duration for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 2, 2009

Status Verified

September 1, 2008

Enrollment Period

2.1 years

First QC Date

March 2, 2006

Last Update Submit

January 30, 2009

Conditions

PainBreast Diseases

Keywords

Randomized controlled trialClinical trialBreast tumor surgeryOutpatient surgeryAnalgesiaOutpatient analgesiaPost surgical analgesia≥ 18 and ≤ 70 years of ageElective outpatient breast surgery for:lumpectomy/quadrantectomy +/- Sentinel Lymph Node Biopsylumpectomy/quadrantectomy with Axillary Node Dissectionsimple mastectomy +/- Sentinel Lymph Node BiopsyModified Radical mastectomy

Outcome Measures

Primary Outcomes (6)

  • VAS Scores.

    mean and daily

  • maximum VAS scores.

    daily

  • Likert scores.

    mean daily and final

  • Patient satisfaction with analgesic regimen.

    day 7

  • Treatment failures-inadequate pain relief or inability to tolerate side effects.

    daily

  • Time to stopping medication.

    day 7

Secondary Outcomes (5)

  • Total Pain relief (TOTPAR).

    daily

  • Sum of pain intensity differences (SPID).

    day7

  • Amount of medication used.

    day 7

  • Incidence of side effects.

    day 7

  • Compliance with regimen.

    day 7

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: acetaminophen plus codeine

2

ACTIVE COMPARATOR
Drug: acetaminophen plus ibuprofen

Interventions

acetaminophen plus codeineDRUG

capsules four times daily until pain free or for a maximum of seven days

1
acetaminophen plus ibuprofenDRUG

capsules four times daily until pain free or for a maximum of seven days

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ages 18 to 70 inclusive
  • outpatient breast surgery: lumpectomy; mastectomy, simple or modified; with or without sentinel lymph node biopsy, axillary node dissection.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

MeSH Terms

Conditions

PainBreast DiseasesAgnosia

Interventions

AcetaminophenCodeineIbuprofen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Alex D Mitchell, MD

    CDHA, Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2006

First Posted

March 6, 2006

Study Start

May 1, 2006

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

February 2, 2009

Record last verified: 2008-09

Locations

CA(1)