Comparison of Tramacet Versus Percocet in Post Surgical Patients
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Tramacet
Percocet
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Post Operative Pain, Addiction
Eligibility Criteria
Inclusion Criteria age 18-65
opioid naïve
postoperative from mild to moderate pain risk surgery (surgery in which patients do not generally require a patient controlled Analgesic pump post-operatively, or require post operative analgesia beyond 14 days)
Exclusion Criteria:
Patients on Opioids
Children < 18 years
Elderly
Pregnancy
Language barrier
Past medical history of psychosis
Coexisting use of anti-depressants
American Society of Anesthesia Risk Score >3
Known allergy to opioid or acetaminophen
Sites / Locations
- Victoria Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tramacet
Percocet
Arm Description
Tramacet 1-2 tabs PO q4h prn
Percocet (5/325) 1-2 tab PO q4h PRN
Outcomes
Primary Outcome Measures
Sought Second Prescription
What patients have sought a second opioid prescription post operatively
Secondary Outcome Measures
Full Information
NCT ID
NCT02361567
First Posted
February 6, 2015
Last Updated
November 2, 2018
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02361567
Brief Title
Comparison of Tramacet Versus Percocet in Post Surgical Patients
Official Title
Comparison of Tramacet Versus Percocet in Post Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of discharge following mild to moderate pain risk surgery. The following will be assessed: 1) Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3) Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat opioid prescription. It is expected that both groups will have similar pain outcomes but those patients in the Percocet group will be more likely to seek a second prescription.
Detailed Description
Patient operating lists will be screened on a daily basis at identify potential patient candidates. The surgeon of note will be consulted to ensure that each patient, in their opinion, may be a candidate. If approved by the surgeon of note, the patient will then be approached in the preoperative area by a member of the research team to determine if they will consent to enrollment in the study.
Patients will be double blinded and randomized following low to moderate pain surgery (surgery in which patients do not generally require a patient controlled analgesic pump post-operatively, or require post operative analgesia beyond 14 days) to receive either tramacet 1-2 tablets orally every 4 hours prn or percocet 1-2 tablets orally every 4 prn. At time of discharge patients will recieve unidentifiable tablets in an unidentifying container of the usual dispense amount that their surgeon would standardly prescribe(range is usually between 30 and 60 tabs).
At 6 weeks patients will receive a phone call to determine a) brief pain inventory score for the month. B) if they sought a second opioid prescription. C) if they plan to seek a second script. E) satisfaction of post operative pain control on a 1-10 numerical scale f) any adverse side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Post Operative Pain, Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tramacet
Arm Type
Active Comparator
Arm Description
Tramacet 1-2 tabs PO q4h prn
Arm Title
Percocet
Arm Type
Active Comparator
Arm Description
Percocet (5/325) 1-2 tab PO q4h PRN
Intervention Type
Drug
Intervention Name(s)
Tramacet
Other Intervention Name(s)
tramadol/acetominophen
Intervention Description
Pain medication commonly used post-operatively
Intervention Type
Drug
Intervention Name(s)
Percocet
Other Intervention Name(s)
oxycodone/acetominophen
Intervention Description
Pain medication commonly used post-operatively
Primary Outcome Measure Information:
Title
Sought Second Prescription
Description
What patients have sought a second opioid prescription post operatively
Time Frame
6 weeks post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria age 18-65
opioid naïve
postoperative from mild to moderate pain risk surgery (surgery in which patients do not generally require a patient controlled Analgesic pump post-operatively, or require post operative analgesia beyond 14 days)
Exclusion Criteria:
Patients on Opioids
Children < 18 years
Elderly
Pregnancy
Language barrier
Past medical history of psychosis
Coexisting use of anti-depressants
American Society of Anesthesia Risk Score >3
Known allergy to opioid or acetaminophen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Collin Clarke, MD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
12. IPD Sharing Statement
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Comparison of Tramacet Versus Percocet in Post Surgical Patients
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