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Completed

NCT Number: NCT05283499

Opioid Analgesic Reduction Study (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.

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Key information

Conditions

Post Operative Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Illinois Chicago, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Opioid

Drug

Analgesic assignment

Other names: Opioid containing analgesic

NON-OPIOID

Drug

Analgesic assignment

Other names: Non-opioid contains analgesic

Primary outcomes

  1. Pain Level

    Time frame: 1st day

    Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)

  2. Pain Level

    Time frame: Average for the 1st and 2nd day

    Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

  3. Pain Level

    Time frame: Average for the first seven days post surgery

    Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

Secondary outcomes

  1. Sleep Quality

    Time frame: 1st night

    Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

  2. Sleep Quality

    Time frame: Average for the 1st and 2nd night

    Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

  3. Sleep Quality

    Time frame: Average for the 1st, 2nd and 3rd night

    Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

  4. Sleep Quality

    Time frame: Average for the first seven nights post surgery

    Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)

  5. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )

    Time frame: 1st day

    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

  6. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )

    Time frame: Average for the 1st and 2nd day

    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

  7. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )

    Time frame: Average for the 1st, 2nd and 3rd day

    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

  8. Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )

    Time frame: Average for the first seven days post surgery

    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

  9. Overall Satisfaction

    Time frame: Average for the first seven days post surgery

    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)

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • University of Illinois at Chicago
  • University of Maryland, Baltimore
  • University of Michigan
  • University of Rochester

Registry information

Acronym: OARS-Pilot

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
Jun 6, 2023

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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