Clinical trial NCT05283499: Opioid Analgesic Reduction Study (OARS) - Pilot
Official title: Opioid Analgesic Reduction Study (OARS) - Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Operative Pain
Keywords: Opioids
Pain Management
Analgesics
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: University of Maryland, Baltimore
name: University of Michigan
name: University of Rochester
First posted: 2022-03-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: Pain Level
timeFrame: 1st day
measure: Pain Level
timeFrame: Average for the 1st and 2nd day
measure: Pain Level
timeFrame: Average for the first seven days post surgery
Secondary outcomes:
measure: Sleep Quality
timeFrame: 1st night
measure: Sleep Quality
timeFrame: Average for the 1st and 2nd night
measure: Sleep Quality
timeFrame: Average for the 1st, 2nd and 3rd night
measure: Sleep Quality
timeFrame: Average for the first seven nights post surgery
measure: Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
timeFrame: 1st day
measure: Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
timeFrame: Average for the 1st and 2nd day
measure: Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
timeFrame: Average for the 1st, 2nd and 3rd day
measure: Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
timeFrame: Average for the first seven days post surgery
measure: Overall Satisfaction
timeFrame: Average for the first seven days post surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois 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 University
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Janine Fredericks-Younger, DMD
role: STUDY_DIRECTOR
References: