Comparison of Tramacet Versus Percocet in Post Surgical Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Tramacet Versus Percocet in Post Surgical Patients

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Tramacet
* Drug: Percocet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramacet<br>Tramacet 1-2 tabs PO q4h prn | Drug: Tramacet<br>* Pain medication commonly used post-operatively<br>* Other names: tramadol/acetominophen;|
| Active Comparator: Percocet<br>Percocet (5/325) 1-2 tab PO q4h PRN | Drug: Percocet<br>* Pain medication commonly used post-operatively<br>* Other names: oxycodone/acetominophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sought Second Prescription | What patients have sought a second opioid prescription post operatively | 6 weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Operative Pain, Addiction