Post Operative PainPhase 3OARS-PilotNCT05283499
Opioid Analgesic Reduction Study (OARS) - Pilot
A Phase 3 study testing OPIOID and NON-OPIOID in people with Post Operative Pain, run by Rutgers, The State University of New Jersey at 5 sites in United States.
Trial summary
The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- OPIOID and NON-OPIOID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Jul 2020to 26 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
- Subjects who are English speaking and are able to provide consent will be considered.
- Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.
Who cannot join
- Subjects who self-report the following history will be excluded from participating:
- Individual under the age of 18
- History of gastrointestinal bleeding and/or peptic ulcer
- History of renal disease (excluding kidney stones)
- History of hepatic disease
- History of bleeding disorder
Show all 21Show fewer
- History of respiratory depression
- Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively
- Active or untreated asthma
- History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
- Currently taking any of the following medications:
- CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
- CNS depressants.
- Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
- History of drug or alcohol abuse (excludes marijuana use)
- Family history of drug or alcohol abuse in a first degree relative
- Has had one or more opioid prescription filled within the past 6 months
- Currently pregnant or lactating
- Patients would also be excluded due to any additional criteria that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study which includes:
- Prior participation in this study
- Inability or refusal to provide informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
University of Illinois Chicago
Chicago, Illinois, 60607
Rutgers University
Newark, New Jersey, 07103
University of Rochester
Rochester, New York, 14642
About this study
The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.
Read the detailed description
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
- Conditions
- Post Operative Pain
- Being tested
- OPIOID, NON-OPIOID
- Keywords
- Opioids, Pain Management, Analgesics
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPIOIDDrug
Also called Opioid containing analgesic
Analgesic assignment
NON-OPIOIDDrug
Also called Non-opioid contains analgesic
Analgesic assignment
| Study group | Role | What they receive |
|---|---|---|
| Opioid | Active comparator | Combination analgesic of hydrocodone 5mg/acetaminophen350 mg Receives: Drug: OPIOID |
| Non-Opioid | Active comparator | Combination analgesic of ibuprofen 400mgacademinophen 350mg Receives: Drug: NON-OPIOID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Measured: 1st day
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Measured: Average for the 1st and 2nd day
Pain Level
Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Measured: Average for the first seven days post surgery
Secondary outcomes (9)
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Measured: 1st night
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Measured: Average for the 1st and 2nd night
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Measured: Average for the 1st, 2nd and 3rd night
Sleep Quality
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Measured: Average for the first seven nights post surgery
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)
The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?
Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Measured: 1st day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)
The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?
Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Measured: Average for the 1st and 2nd day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)
The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?
Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Measured: Average for the 1st, 2nd and 3rd day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always)
The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others?
Minimum = 6, Maximum = 30; lower is better and higher is worse outcome
Measured: Average for the first seven days post surgery
Overall Satisfaction
Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)
Measured: Average for the first seven days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start6 Jul 2020
- Primary completion12 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois at Chicago, University of Maryland, Baltimore, University of Michigan, University of Rochester
- Responsible party
- Principal investigator, Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey
- Investigators
- Janine Fredericks-Younger, DMD, Study director, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283499
- Sponsor's protocol ID
- Pro2020001891
- Acronym
- OARS-Pilot
- Status last verified
- Jun 2023
- First submitted
- 23 Feb 2022
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon written request to the principle investigator data will be provided as de-identified data in csv file format.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Analgesic Reduction Study (OARS) - Pilot
- ClinicalTrials.gov ID
- NCT05283499
- Acronym / sponsor ID
- OARS-Pilot / Pro2020001891
- Conditions
- Post Operative Pain
- Keywords
- Opioids, Pain Management, Analgesics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Illinois at Chicago, University of Maryland, Baltimore, University of Michigan, University of Rochester
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.
Detailed description
A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.
| Arm | Type | Receives |
|---|---|---|
| Opioid | Active comparator | Drug: OPIOIDCombination analgesic of hydrocodone 5mg/acetaminophen350 mg |
| Non-Opioid | Active comparator | Drug: NON-OPIOIDCombination analgesic of ibuprofen 400mgacademinophen 350mg |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
- Subjects who are English speaking and are able to provide consent will be considered.
- Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.
Key exclusion criteria (21 listed)
- Individual under the age of 18
- History of gastrointestinal bleeding and/or peptic ulcer
- History of renal disease (excluding kidney stones)
- History of hepatic disease
- History of bleeding disorder
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 |
|---|---|---|
| OPIOIDAlso: Opioid containing analgesicAnalgesic assignment | Drug | Opioid |
| NON-OPIOIDAlso: Non-opioid contains analgesicAnalgesic assignment | Drug | Non-Opioid |
Primary outcome
Pain Level
Time frame: 1st day
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Pain Level
Time frame: Average for the 1st and 2nd day
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Pain Level
Time frame: Average for the first seven days post surgery
Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
9 secondary outcomes
Sleep Quality
Time frame: 1st night
Sleep Quality
Time frame: Average for the 1st and 2nd night
Sleep Quality
Time frame: Average for the 1st, 2nd and 3rd night
Sleep Quality
Time frame: Average for the first seven nights post surgery
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Time frame: 1st day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Time frame: Average for the 1st and 2nd day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Time frame: Average for the 1st, 2nd and 3rd day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Time frame: Average for the first seven days post surgery
Overall Satisfaction
Time frame: Average for the first seven days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon written request to the principle investigator data will be provided as de-identified data in csv file format.
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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.
Janine Fredericks-Younger, DMD study director
Rutgers School of Dental Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OPIOID and NON-OPIOID in people with Post Operative Pain, run by Rutgers, The State University of New Jersey at 5 sites in United States.
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 3 inclusion and 21 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Level (time frame: 1st day). The study lists 3 primary outcomes in all. 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 Jun 2023.