Opioid Analgesic Reduction Study (OARS) - Pilot (OARS-Pilot)

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: OPIOID; Drug: NON-OPIOID

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois Chicago
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers University
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid; Combination analgesic of hydrocodone 5mg/acetaminophen350 mg	Drug: OPIOID; Analgesic assignment; Other Names: Opioid containing analgesic
Active Comparator: Non-Opioid; Combination analgesic of ibuprofen 400mgacademinophen 350mg	Drug: NON-OPIOID; Analgesic assignment; Other Names: Non-opioid contains analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)	1st day
Pain Level	Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain	Average for the 1st and 2nd day
Pain Level	Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain	Average for the first seven days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	1st night
Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	Average for the 1st and 2nd night
Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	Average for the 1st, 2nd and 3rd night
Sleep Quality	Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)	Average for the first seven nights post surgery
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	1st day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	Average for the 1st and 2nd day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	Average for the 1st, 2nd and 3rd day
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )	Impact of pain on subject's ability to perform normal daily functions. The sum of six questions rated on a 5 point Likert Scale (1=not at all or never, 2=a little bit or rarely, 3=somewhat or sometimes, 4=quite a bit or often and 5=very much or always) The six questions are: 1) how much did pain interfere with your enjoyment of life, 2) how much did pain interfere with your ability to concentrate, 3) how much did pain interfere with your day to day activities, 4) how much did pain interfere with your enjoyment of recreational activities 5) how much did pain interfere with your tasks away form and home and 6) how often did pain keep you from socializing with others? Minimum = 6, Maximum = 30; lower is better and higher is worse outcome	Average for the first seven days post surgery
Overall Satisfaction	Subject's rating of overall satisfaction with the analgesic provided after surgery on a 5 point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied)	Average for the first seven days post surgery

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: University of Maryland, Baltimore; University of Michigan; University of Illinois at Chicago; University of Rochester
• Investigators: Study Director: Janine Fredericks-Younger, DMD, Rutgers School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Opioids; Pain Management; Analgesics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Narcotics; Analgesics, Opioid; Analgesics; Analgesics, Non-Narcotic
• Other Study ID Numbers: Pro2020001891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon written request to the principle investigator data will be provided as de-identified data in csv file format.
• IPD Sharing Time Frame: Data will be available after publication of primary and secondary outcomes. Data will be available for 3 years.
• IPD Sharing Access Criteria: Requester must have a valid e-mail address.

Drug and device information, study documents

• 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.: Yes