Clinical trial NCT04452344: Opioid Analgesic Reduction Study
Official title: Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Opioid Use
Keywords: 3rd molar extraction pain model
Opioid Analgesics
Opioid Diversion
Over the counter analgesics
Acetaminophen
Ibuprofen
Hydrocodone
Opioid Addiction
Pain Management
Satisfaction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: University of Rochester
name: University of Maryland, Baltimore
name: University of Illinois at Chicago
name: University of Michigan
First posted: 2020-06-30
Enrollment: 1815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Composite Pain 1
timeFrame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
measure: Composite Pain 2
timeFrame: End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)
measure: Composite Pain 3
timeFrame: End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)
measure: Composite Pain All
timeFrame: 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)
measure: Overall Satisfaction
timeFrame: At time of post-operative visit (day 9 +/- 5 days)
measure: Pain Worst 1
timeFrame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
measure: Pain Worst 2
timeFrame: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery
measure: Pain Worst 3
timeFrame: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
measure: Pain Worst All
timeFrame: 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)
measure: Pain Average 1
timeFrame: End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
measure: Pain Average 2
timeFrame: End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)
measure: Pain Average 3
timeFrame: End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)
measure: Pain Average All
timeFrame: 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:
measure: Number of Participants Receiving Rescue Medication
timeFrame: At post operative visit (9 days after surgery +/- 5 days)
measure: Pain Interference 1
timeFrame: End of the day of surgery (day 1)
measure: Pain Interference 2
timeFrame: End of the first full day after surgery (day 2)
measure: Pain Interference 3
timeFrame: End of the second full day after surgery (day 3)
measure: Pain Interference All
timeFrame: First 7 days after surgery
measure: Sleep 1
timeFrame: When first waking up the day after surgery
measure: Sleep 2
timeFrame: When first waking up the 2nd day after surgery
measure: Sleep 3
timeFrame: When first waking up the 3rd day after surgery
measure: Sleep All
timeFrame: First 7 nights after surgery
measure: Potential for Opioid Tablet Diversion
timeFrame: At post operative visit (9 days after surgery +/- 5 days)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Cecile A Feldman, DMD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldman 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.