Comparison of Tramacet Versus Percocet in Post Surgical Patients

NCT ID: NCT02361567

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tramacet

Tramacet 1-2 tabs PO q4h prn

Group Type: ACTIVE_COMPARATOR

Tramacet

Intervention Type: DRUG

Pain medication commonly used post-operatively

Percocet

Percocet (5/325) 1-2 tab PO q4h PRN

Group Type: ACTIVE_COMPARATOR

Percocet

Intervention Type: DRUG

Pain medication commonly used post-operatively

Interventions

Tramacet

Pain medication commonly used post-operatively

Intervention Type: DRUG

Percocet

Pain medication commonly used post-operatively

Intervention Type: DRUG

Other Intervention Names

tramadol/acetominophen; oxycodone/acetominophen

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Collin Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

Victoria Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

103278

Identifier Type: -

Identifier Source: org_study_id