Back to resultsOpioid Analgesic Reduction Study (OARS) - Pilot (OARS-Pilot)
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OPIOID
NON-OPIOID
Sponsored by
About this trial
This is an interventional supportive care trial for Post Operative Pain focused on measuring Opioids, Pain Management, Analgesics
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
Sites / Locations
- University of Illinois Chicago
- University of Maryland
- University of Michigan
- Rutgers University
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Opioid
Non-Opioid
Arm Description
Combination analgesic of hydrocodone 5mg/acetaminophen350 mg
Combination analgesic of ibuprofen 400mgacademinophen 350mg
Outcomes
Primary Outcome Measures
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Pain Level
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Pain Level
Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Secondary Outcome Measures
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)
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)
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)
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)
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
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
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
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
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)
Full Information
NCT ID
NCT05283499
First Posted
February 23, 2022
Last Updated
June 2, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of Illinois at Chicago, University of Maryland, Baltimore, University of Michigan, University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT05283499
Brief Title
Opioid Analgesic Reduction Study (OARS) - Pilot
Acronym
OARS-Pilot
Official Title
Opioid Analgesic Reduction Study (OARS) - Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
University of Illinois at Chicago, University of Maryland, Baltimore, University of Michigan, University of Rochester
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Opioids, Pain Management, Analgesics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opioid
Arm Type
Active Comparator
Arm Description
Combination analgesic of hydrocodone 5mg/acetaminophen350 mg
Arm Title
Non-Opioid
Arm Type
Active Comparator
Arm Description
Combination analgesic of ibuprofen 400mgacademinophen 350mg
Intervention Type
Drug
Intervention Name(s)
OPIOID
Other Intervention Name(s)
Opioid containing analgesic
Intervention Description
Analgesic assignment
Intervention Type
Drug
Intervention Name(s)
NON-OPIOID
Other Intervention Name(s)
Non-opioid contains analgesic
Intervention Description
Analgesic assignment
Primary Outcome Measure Information:
Title
Pain Level
Description
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)
Time Frame
1st day
Title
Pain Level
Description
Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Time Frame
Average for the 1st and 2nd day
Title
Pain Level
Description
Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain
Time Frame
Average for the first seven days post surgery
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame
1st night
Title
Sleep Quality
Description
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame
Average for the 1st and 2nd night
Title
Sleep Quality
Description
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame
Average for the 1st, 2nd and 3rd night
Title
Sleep Quality
Description
Quality of overall sleep (self reported by subject) rated on numeric rating scale (0=best possible sleep possible, 10=worst possible sleep possible)
Time Frame
Average for the first seven nights post surgery
Title
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description
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
Time Frame
1st day
Title
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description
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
Time Frame
Average for the 1st and 2nd day
Title
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description
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
Time Frame
Average for the 1st, 2nd and 3rd day
Title
Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )
Description
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
Time Frame
Average for the first seven days post surgery
Title
Overall Satisfaction
Description
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)
Time Frame
Average for the first seven days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janine Fredericks-Younger, DMD
Organizational Affiliation
Rutgers School of Dental Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Rutgers University
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Opioid Analgesic Reduction Study (OARS) - Pilot
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