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Opioid Analgesic Reduction Study (OARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452344
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : January 14, 2022
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
University of Rochester
University of Maryland, Baltimore
University of Illinois at Chicago
University of Michigan
Information provided by (Responsible Party):
Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey

Brief 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 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.


Condition or disease Intervention/treatment Phase
Opioid Use Drug: opioid-containing analgesic Drug: two over-the-counter analgesics Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
Actual Study Start Date : January 4, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Active Comparator: Opioid
Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
Drug: opioid-containing analgesic
hydrocodone/ acetaminophen combination product

Active Comparator: Non-Opioid
Combination of ibuprofen 400 mg/acetaminophen 500 mg
Drug: two over-the-counter analgesics
combination of over-the-counter analgesics (ibuprofen/acetaminophen)




Primary Outcome Measures :
  1. Brief Pain Inventory pain scale using Numeric Rating Scale [ Time Frame: the first 24 hours post surgery ]
    Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)

  2. Brief Pain Inventory pain scale using Numeric Rating Scale [ Time Frame: the first 48 hours post surgery ]
    Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)

  3. Brief Pain Inventory pain scale using Numeric Rating Scale [ Time Frame: the first 7 days post surgery ]
    Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)

  4. PTSS satisfaction questions assessing overall satisfaction [ Time Frame: At post operative visit (9 days after surgery +/- 5 days) ]

    How satisfied are you with the TIME that it takes your pain medication to work? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)

    • How satisfied are you with the LEVEL OF AMOUNT of pain relief provided by your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)
    • How satisfied are you with the DURATION of pain relief provided by your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)
    • Overall, how satisfied are you with your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)
    • Overall, how does your level of pain relief meet you expectations of pain relief? (5 pt. scale: 1=greatly exceeds my expectations, 5=does not meet my expectations at all)
    • Do you think that your pain medication could be more effective in relieving your pain? (5 pt. scale: 1=yes, definitely, 5=definitely not)


Secondary Outcome Measures :
  1. Adverse events experienced [ Time Frame: Total events recorded each morning and evening after surgery for the first 24 hours post surgery ]
    Total adverse events experienced (count of yes answers to excessive fatigue or drowsiness, inability to concentrate, nausea, diarrhea, dizziness, constipation, skin rashes, stomach aches, heartburn, vomiting, euphoria, headache, urinary retention and unintentional weight gain)

  2. Adverse events experienced [ Time Frame: Total events recorded each morning and evening after surgery for the first 48 hours post surgery ]
    Total adverse events experienced (count of yes answers to excessive fatigue or drowsiness, inability to concentrate, nausea, diarrhea, dizziness, constipation, skin rashes, stomach aches, heartburn, vomiting, euphoria, headache, urinary retention and unintentional weight gain)

  3. Adverse events experienced [ Time Frame: Total events recorded each morning and evening for the first 7 days post surgery ]
    Total adverse events experienced (count of yes answers to excessive fatigue or drowsiness, inability to concentrate, nausea, diarrhea, dizziness, constipation, skin rashes, stomach aches, heartburn, vomiting, euphoria, headache, urinary retention and unintentional weight gain)

  4. Pain interference (daily function) [ Time Frame: Day 2 post surgery (recorded the evening of day 2) ]
    Mean score of Patient-Reported Outcomes Measurement Information System questions related to pain interference: During the post-operative period, how much did pain interfere with your 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}

  5. Pain interference (daily function) [ Time Frame: Days 2 and 3 post surgery (recorded the evenings of days 2 and 3) ]
    Mean score of Patient-Reported Outcomes Measurement Information System questions related to pain interference: During the post-operative period, how much did pain interfere with your 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}

  6. Pain interference (daily function) [ Time Frame: First 7 days post surgery ]
    Mean score of Patient-Reported Outcomes Measurement Information System questions related to pain interference: During the post-operative period, how much did pain interfere with your 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}

  7. Sleep quality (Questions from PSQ-3) [ Time Frame: For the first night post surgery ]
    • Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? {Binary yes/no)

  8. Sleep quality (Questions from PSQ-3) [ Time Frame: For the first 2 nights post surgery ]
    • Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? {Binary yes/no)

  9. Sleep Quality (Questions from PSQ-3) [ Time Frame: For the first 7 nights post surgery ]
    • Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? {Binary yes/no)

  10. Sleep Quality (PSQ-3) [ Time Frame: Recorded during Visit 2 (Post operative visit 9 days +/-5 days post surgery) ]
    • Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? NRS scale where 0=never, 10=always

  11. Overall satisfaction with sleep [ Time Frame: For the first 7 evenings post surgery ]
    NRS where 0=never, 10=always

  12. Overall satisfaction with sleep [ Time Frame: For the first 7 evenings post surgery ]
    From PTSS: Rating the overall quality of last night's sleep {NRS where 0=excellent and10=very poor}

  13. Potential for opioid tablet diversion [ Time Frame: At post operative visit (9 days after surgery +/- 5 days) ]
    Number of returned analgesic capsules at post operative visit (9 days after surgery +/- 5 days)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452344


Contacts
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Contact: Julie Chapman-Greene, PhD 973-972-3620 chapmaje@sdm.rutgers.edu
Contact: Janine Fredericks-Younger, DMD 973-972-1679 frederja@sdm.rutgers.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Michael Miloro, DMD, MD    312-996-1052    mmiloro@uic.edu   
Sub-Investigator: Michael Miloro, DMD, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Gary Warburton, DDS    410-706-7060    GWarburton@umaryland.edu   
Sub-Investigator: Gary Warburton, DDS         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Brent Ward, DMD, MD    734-936-5941    bward@med.umich.edu   
Sub-Investigator: Brent Ward, DMD, MD         
United States, New Jersey
Rutgers School of Dental Medicine Recruiting
Newark, New Jersey, United States, 07101
Contact: Vincent Zaccardi, DMD, MD    973-972-7462    ziccarvb@sdm.rutgers.edu   
Sub-Investigator: Vincent Zaccardi, DMD, MD         
Principal Investigator: Cecile Feldman, DMD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Hans Malmstrom, DDS    585-273-5087    Hans_Malmstrom@URMC.Rochester.edu   
Sub-Investigator: Hans Malmstrom, DDS         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute of Dental and Craniofacial Research (NIDCR)
University of Rochester
University of Maryland, Baltimore
University of Illinois at Chicago
University of Michigan
Investigators
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Principal Investigator: Cecile A Feldman, DMD Rutgers, The State University of New Jersey
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cecile A. Feldman, DMD, Dean and Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT04452344    
Other Study ID Numbers: Pro2020002299
1UG3DE028860-01 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: 12 months after publication
Access Criteria: Request data access from the PI.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cecile A. Feldman, DMD, Rutgers, The State University of New Jersey:
3rd molar extraction pain model
Opioid Analgesics
Opioid Diversion
Over the counter analgesics
Acetaminophen
Ibuprofen
Hydrocodone
Opioid Addiction
Pain Management
Satisfaction
Additional relevant MeSH terms:
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Analgesics
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents