Comparison of Tramacet Versus Percocet in Post Surgical Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Tramacet Tramacet 1-2 tabs PO q4h prn |
Drug: Tramacet
Pain medication commonly used post-operatively
Other Names:
|
| Active Comparator: Percocet Percocet (5/325) 1-2 tab PO q4h PRN |
Drug: Percocet
Pain medication commonly used post-operatively
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sought Second Prescription [6 weeks post-operative]
What patients have sought a second opioid prescription post operatively
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Collin Clarke, MD, Lawson Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 103278