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Comparison of Tramacet Versus Percocet in Post Surgical Patients

Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Operative Pain

Intervention: Tramacet (Drug); Percocet (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Collin Clarke, MD, Principal Investigator, Affiliation: Lawson Health Research Institute

Overall contact:
Collin Clarke, MD, Phone: 519-685-8500, Ext: 35737, Email: cclarke@uwo.ca

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.

Clinical Details

Official title: Comparison of Tramacet Versus Percocet in Post Surgical Patients

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sought 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Collin Clarke, MD, Phone: 519-685-8500, Ext: 35737, Email: cclarke@uwo.ca

Victoria Hospital, London, Ontario N6A 5W9, Canada; Not yet recruiting
George Nicolau, MD, Phone: 519-685-8500, Ext: 55115, Email: george.nicolau@lhsc.on.ca
Collin FM Clarke, MD, Principal Investigator
Additional Information

Starting date: April 2015
Last updated: February 6, 2015

Page last updated: August 23, 2015

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