Comparison of Tramacet Versus Percocet in Post Surgical Patients

Post Operative Pain Clinical Trial

Official title:

Comparison of Tramacet Versus Percocet in Post Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361567
• Other study ID #: 103278
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Tramacet
Pain medication commonly used post-operatively
• Percocet
Pain medication commonly used post-operatively

Locations

Country	Name	City	State
Canada	Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sought Second Prescription	What patients have sought a second opioid prescription post operatively	6 weeks post-operative