Post Operative PainPhase 4NCT02361567
Comparison of Tramacet Versus Percocet in Post Surgical Patients
A Phase 4 study testing Tramacet and Percocet in people with Post Operative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Tramacet and Percocet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients on Opioids
- Children < 18 years
- Elderly
- Pregnancy
- Language barrier
- Past medical history of psychosis
Show all 9Show fewer
- Coexisting use of anti-depressants
- American Society of Anesthesia Risk Score >3
- Known allergy to opioid or acetaminophen
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Tramacet, Percocet
- Keywords
- Post Operative Pain, Addiction
- Medical subject headings
- Pain, Postoperative, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramacetDrug
Also called tramadol/acetominophen
Pain medication commonly used post-operatively
PercocetDrug
Also called oxycodone/acetominophen
Pain medication commonly used post-operatively
| Study group | Role | What they receive |
|---|---|---|
| Tramacet | Active comparator | Tramacet 1-2 tabs PO q4h prn Receives: Drug: Tramacet |
| Percocet | Active comparator | Percocet (5/325) 1-2 tab PO q4h PRN Receives: Drug: Percocet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sought Second Prescription
What patients have sought a second opioid prescription post operatively
Measured: 6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Collin Clarke, MD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361567
- Sponsor's protocol ID
- 103278
- Status last verified
- Nov 2018
- First submitted
- 6 Feb 2015
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tramacet Versus Percocet in Post Surgical Patients
- ClinicalTrials.gov ID
- NCT02361567
- Acronym / sponsor ID
- 103278
- Conditions
- Post Operative Pain
- Keywords
- Post Operative Pain, Addiction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramacet | Active comparator | Drug: TramacetTramacet 1-2 tabs PO q4h prn |
| Percocet | Active comparator | Drug: PercocetPercocet (5/325) 1-2 tab PO q4h PRN |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- Patients on Opioids
- Children < 18 years
- Elderly
- Pregnancy
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TramacetAlso: tramadol/acetominophenPain medication commonly used post-operatively | Drug | Tramacet |
| PercocetAlso: oxycodone/acetominophenPain medication commonly used post-operatively | Drug | Percocet |
Primary outcome
Sought Second Prescription
Time frame: 6 weeks post-operative
What patients have sought a second opioid prescription post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collin Clarke, MD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramacet and Percocet in people with Post Operative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sought Second Prescription (time frame: 6 weeks post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.