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NCT Number: NCT04452344

Opioid Analgesic Reduction Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Opioid Use Agnosia Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid-Related Disorders Pathological Conditions, Signs and Symptoms Perceptual Disorders Personal Satisfaction Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Illinois at Chicago, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • 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

Exclusion criteria

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
  • 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

Treatment and study plan

opioid-containing analgesic

Drug

hydrocodone/ acetaminophen combination product

two over-the-counter analgesics

Drug

combination of over-the-counter analgesics (ibuprofen/acetaminophen)

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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?"

  6. 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).

  7. 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.)

  8. 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).

  9. 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).

  10. 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)

  11. 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.)

  12. 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).

  13. 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).

Secondary outcomes

  1. Number of Participants Receiving Rescue Medication

    Time frame: At post operative visit (9 days after surgery +/- 5 days)

    Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently

  2. Pain Interference 1

    Time frame: End of the day of surgery (day 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.

  3. Pain Interference 2

    Time frame: End of the first full day after surgery (day 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.

  4. Pain Interference 3

    Time frame: End of the second full day after surgery (day 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.

  5. Pain Interference All

    Time frame: First 7 days after surgery

    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.

  6. Sleep 1

    Time frame: When first waking up the day after surgery

    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.

  7. Sleep 2

    Time frame: When first waking up the 2nd day after surgery

    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.

  8. Sleep 3

    Time frame: When first waking up the 3rd day after surgery

    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.

  9. Sleep All

    Time frame: First 7 nights after surgery

    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.

  10. Potential for Opioid Tablet Diversion

    Time frame: At post operative visit (9 days after surgery +/- 5 days)

    Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days)

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)
  • University of Illinois at Chicago
  • University of Maryland, Baltimore
  • University of Michigan
  • University of Rochester

Registry information

Official study title

Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain

Acronym: OARS

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jun 30, 2020
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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