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Comparison of Tramacet Versus Percocet in Post Surgical Patients

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ClinicalTrials.gov Identifier: NCT02361567
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

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
Post Operative Pain Drug: Tramacet Drug: Percocet 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Tramacet Versus Percocet in Post Surgical Patients
Actual Study Start Date : April 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Tramacet
Tramacet 1-2 tabs PO q4h prn
Drug: Tramacet
Pain medication commonly used post-operatively
Other Name: tramadol/acetominophen

Active Comparator: Percocet
Percocet (5/325) 1-2 tab PO q4h PRN
Drug: Percocet
Pain medication commonly used post-operatively
Other Name: oxycodone/acetominophen




Primary Outcome Measures :
  1. Sought Second Prescription [ Time Frame: 6 weeks post-operative ]
    What patients have sought a second opioid prescription post operatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361567


Locations
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Canada, Ontario
Victoria Hospital
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Collin Clarke, MD Lawson Health Research Institute

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02361567     History of Changes
Other Study ID Numbers: 103278
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawson Health Research Institute:
Post Operative Pain
Addiction
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics