Opioid UsePhase 3OARSNCT04452344
Opioid Analgesic Reduction Study
A Phase 3 study testing opioid-containing analgesic and two over-the-counter analgesics in people with Opioid Use, run by Rutgers, The State University of New Jersey at 5 sites in United States.
Trial summary
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- opioid-containing analgesic and two over-the-counter analgesics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,815 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Jan 2021to 24 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- An individual must meet all of the following criteria to be eligible to participate in the study:
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures and be available for the duration of the study
- Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd molars
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- Be 18 years or older
- Be in good general health as evidenced by medical history
- Women must agree to use one of the following methods of contraception while participating in this study:
- contraceptive pill
- intra-uterine device
- condoms
- abstinence
Who cannot join
- Participants who self-report the following history will be excluded from participating:
- History of gastrointestinal bleeding and/or peptic ulcer
- History of renal disease (excluding kidney stones)
- History of hepatic disease
- History of bleeding disorder
- History of respiratory depression
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- Any prior respiratory effect of an opioid or other anesthetic drugs that required respiratory support postoperatively
- Active or untreated asthma
- History of known allegoric 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
- Family history of drug or alcohol abuse in a first-degree relative
- Has had no more than one opioid prescription filled within the past 12 months
- Currently pregnant or lactating
- Participants 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 at Chicago
Chicago, Illinois, 60612
Rutgers School of Dental Medicine
Newark, New Jersey, 07101
University of Rochester
Rochester, New York, 14620
About this study
Official title: Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results.
This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.
- Conditions
- Opioid Use
- Being tested
- opioid-containing analgesic, two over-the-counter analgesics
- Keywords
- 3rd molar extraction pain model, Opioid Analgesics, Opioid Diversion, Over the counter analgesics, Acetaminophen, Ibuprofen, Hydrocodone, Opioid Addiction, Pain Management, Satisfaction
- Medical subject headings
- Opioid-Related Disorders, Agnosia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid-containing analgesicDrug
hydrocodone/ acetaminophen combination product
two over-the-counter analgesicsDrug
combination of over-the-counter analgesics (ibuprofen/acetaminophen)
| Study group | Role | What they receive |
|---|---|---|
| Opioid | Active comparator | Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. Receives: Drug: opioid-containing analgesic |
| Non-Opioid | Active comparator | Combination of ibuprofen 400 mg/acetaminophen 500 mg Receives: Drug: two over-the-counter analgesics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Pain 1
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Measured: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Composite Pain 2
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Measured: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
Composite Pain 3
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Measured: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Composite Pain All
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Measured: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Overall Satisfaction
Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Measured: At time of post-operative visit (day 9 +/- 5 days)
Pain Worst 1
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Measured: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Pain Worst 2
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Measured: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery
Pain Worst 3
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Measured: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Pain Worst All
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Measured: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Pain Average 1
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Measured: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Pain Average 2
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Measured: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
Pain Average All
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Measured: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Pain Average 3
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Measured: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Secondary outcomes (10)
Number of Participants Receiving Rescue Medication
Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently
Measured: At post operative visit (9 days after surgery +/- 5 days)
Pain Interference 1
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 1 is the average ratings provided at the end of the day of surgery. Lower scores are better.
Measured: End of the day of surgery (day 1)
Pain Interference 2
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 2 is the average ratings provided at the end of day after surgery (day 2). Lower scores are better.
Measured: End of the first full day after surgery (day 2)
Pain Interference 3
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference 3 is the average ratings provided at the end of 2nd day after surgery (day 3). Lower scores are better.
Measured: End of the second full day after surgery (day 3)
Pain Interference All
Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always} Pain Interference ALL is the average ratings provided at the end of the 1st seven days after surgery (days 1 thru 7). Lower scores are better.
Measured: First 7 days after surgery
Sleep 1
Participants were asked to rate the overall quality of their sleep the 1st night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the day after surgery.
Measured: When first waking up the day after surgery
Sleep 2
Participants were asked to rate the overall quality of their sleep the 2nd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 2 is the rating provided when first waking up the second day after surgery.
Measured: When first waking up the 2nd day after surgery
Sleep 3
Participants were asked to rate the overall quality of their sleep the 3rd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the third day after surgery.
Measured: When first waking up the 3rd day after surgery
Sleep All
Participants were asked to rate the overall quality of their sleep for the first 7 nights after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep All is the average rating provided for all seven nights.
Measured: First 7 nights after surgery
Potential for Opioid Tablet Diversion
Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days)
Measured: At post operative visit (9 days after surgery +/- 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start4 Jan 2021
- Primary completion7 Jul 2023
- Study completion24 Dec 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Rochester, University of Maryland, Baltimore, University of Illinois at Chicago, University of Michigan
- Responsible party
- Principal investigator, Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey
- Investigators
- Cecile A Feldman, DMD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452344
- Sponsor's protocol ID
- Pro2020002299
- Other IDs
- 5UH3DE028860-05
- Acronym
- OARS
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2020
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Electronic Data Capture (EDC) will be used extensively throughout the course of the study for the collection of patient data as well as driving operational/logistical workflows. The database with data dictionary will be available.
Publications
Feldman CA, Fredericks-Younger J, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward BB, Ziccardi VB, Greenberg P, Andrews T, Matheson PB, Benoliel R, Fine DH, Lu SE. Nonopioid vs opioid analgesics after impacted third-molar extractions: The Opioid Analgesic Reduction Study randomized clinical trial. J Am Dent Assoc. 2025 Feb;156(2):110-123.e9. doi: 10.1016/j.adaj.2024.10.014. Epub 2025 Jan 4.
PubMed 39755971Feldman CA, Fredericks-Younger J, Lu SE, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward B, Ziccardi V, Fine D. The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial. Trials. 2022 Feb 17;23(1):160. doi: 10.1186/s13063-022-06064-8.
PubMed 35177108
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
- ClinicalTrials.gov ID
- NCT04452344
- Acronym / sponsor ID
- OARS / Pro2020002299
- Conditions
- Opioid Use
- Keywords
- 3rd molar extraction pain model, Opioid Analgesics, Opioid Diversion, Over the counter analgesics, Acetaminophen, Ibuprofen, Hydrocodone, Opioid Addiction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,815 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), University of Rochester, University of Maryland, Baltimore, University of Illinois at Chicago, University of Michigan
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 24 Dec 2023 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Posted 30 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results.
This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.
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
| Arm | Type | Receives |
|---|---|---|
| Opioid | Active comparator | Drug: opioid-containing analgesicCombination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill. |
| Non-Opioid | Active comparator | Drug: two over-the-counter analgesicsCombination of ibuprofen 400 mg/acetaminophen 500 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- An individual must meet all of the following criteria to be eligible to participate in the study:
- Be able to understand the informed consent.
- Provide signed and dated informed consent form
- Be able to understand all directions for data gathering instruments in English
- Be willing and able to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (20 listed)
- History of gastrointestinal bleeding and/or peptic ulcer
- History of renal disease (excluding kidney stones)
- History of hepatic disease
- History of bleeding disorder
- History of respiratory depression
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 |
|---|---|---|
| opioid-containing analgesichydrocodone/ acetaminophen combination product | Drug | Opioid |
| two over-the-counter analgesicscombination of over-the-counter analgesics (ibuprofen/acetaminophen) | Drug | Non-Opioid |
Primary outcome
Composite Pain 1
Time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Composite Pain 2
Time frame: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Composite Pain 3
Time frame: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Composite Pain All
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Overall Satisfaction
Time frame: At time of post-operative visit (day 9 +/- 5 days)
Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Pain Worst 1
Time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Pain Worst 2
Time frame: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Pain Worst 3
Time frame: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Pain Worst All
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Average 1
Time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Pain Average 2
Time frame: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Pain Average All
Time frame: End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Average 3
Time frame: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
10 secondary outcomes
Number of Participants Receiving Rescue Medication
Time frame: At post operative visit (9 days after surgery +/- 5 days)
Pain Interference 1
Time frame: End of the day of surgery (day 1)
Pain Interference 2
Time frame: End of the first full day after surgery (day 2)
Pain Interference 3
Time frame: End of the second full day after surgery (day 3)
Pain Interference All
Time frame: First 7 days after surgery
Sleep 1
Time frame: When first waking up the day after surgery
Sleep 2
Time frame: When first waking up the 2nd day after surgery
Sleep 3
Time frame: When first waking up the 3rd day after surgery
Sleep All
Time frame: First 7 nights after surgery
Potential for Opioid Tablet Diversion
Time frame: At post operative visit (9 days after surgery +/- 5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39755971Feldman CA, Fredericks-Younger J, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward BB, Ziccardi VB, Greenberg P, Andrews T, Matheson PB, Benoliel R, Fine DH, Lu SE. Nonopioid vs opioid analgesics after impacted third-molar extractions: The Opioid Analgesic Reduction Study randomized clinical trial. J Am Dent Assoc. 2025 Feb;156(2):110-123.e9. doi: 10.1016/j.adaj.2024.10.014. Epub 2025 Jan 4.
- Derived from this study: PubMed 35177108Feldman CA, Fredericks-Younger J, Lu SE, Desjardins PJ, Malmstrom H, Miloro M, Warburton G, Ward B, Ziccardi V, Fine D. The Opioid Analgesic Reduction Study (OARS)-a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial. Trials. 2022 Feb 17;23(1):160. doi: 10.1186/s13063-022-06064-8.
- Individual participant dataSharing planned: Yes. Electronic Data Capture (EDC) will be used extensively throughout the course of the study for the collection of patient data as well as driving operational/logistical workflows. The database with data dictionary will be available.
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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.
Cecile A Feldman, DMD principal investigator
Rutgers, The State University of New Jersey
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-containing analgesic and two over-the-counter analgesics in people with Opioid Use, 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 13 inclusion and 20 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 31 Aug 2026. 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 30 Jul 2024). 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?
Composite Pain 1 (time frame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452344, which also lists 2 linked publications.
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 31 Aug 2026.