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
|