Comparison of Tramacet Versus Percocet in Post Surgical Patients

NCT02361567 | Completed Phase 4

• 1 other identifier: 103278
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

Post Operative Pain; Addiction

Outcome Measures

Primary Outcomes (1)

• Sought Second Prescription

  What patients have sought a second opioid prescription post operatively

  6 weeks post-operative

Study Arms (2)

Tramacet

ACTIVE COMPARATOR

Tramacet 1-2 tabs PO q4h prn

Drug: Tramacet

Percocet

ACTIVE COMPARATOR

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

Drug: Percocet

Interventions

Tramacet DRUG

Pain medication commonly used post-operatively

Also known as: tramadol/acetominophen

Tramacet

Percocet DRUG

Pain medication commonly used post-operatively

Also known as: oxycodone/acetominophen

Percocet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative; Behavior, Addictive

Interventions

Tramadol; Acetaminophen; oxycodone-acetaminophen; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Collin Clarke, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)