Opioid Analgesic Reduction Study

Opioid Use Clinical Trial

— OARS  

Official title:

Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04452344
• Other study ID #: Pro2020002299
• Secondary ID: 1UG3DE028860-01
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 4, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Drug:
• opioid-containing analgesic
hydrocodone/ acetaminophen combination product
• two over-the-counter analgesics
combination of over-the-counter analgesics (ibuprofen/acetaminophen)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Rutgers School of Dental Medicine	Newark	New Jersey
United States	University of Rochester	Rochester	New York

Sponsors (6)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute of Dental and Craniofacial Research (NIDCR), University of Illinois at Chicago, University of Maryland, Baltimore, University of Michigan, University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory pain scale using Numeric Rating Scale	Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)	the first 24 hours post surgery
Primary	Brief Pain Inventory pain scale using Numeric Rating Scale	Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)	the first 48 hours post surgery
Primary	Brief Pain Inventory pain scale using Numeric Rating Scale	Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)	the first 7 days post surgery
Primary	PTSS satisfaction questions assessing overall satisfaction	How satisfied are you with the TIME that it takes your pain medication to work? (5 pt. scale: 1=very satisfied, 5=very dissatisfied); How satisfied are you with the LEVEL OF AMOUNT of pain relief provided by your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied); How satisfied are you with the DURATION of pain relief provided by your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied); Overall, how satisfied are you with your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied); Overall, how does your level of pain relief meet you expectations of pain relief? (5 pt. scale: 1=greatly exceeds my expectations, 5=does not meet my expectations at all); Do you think that your pain medication could be more effective in relieving your pain? (5 pt. scale: 1=yes, definitely, 5=definitely not)	At post operative visit (9 days after surgery +/- 5 days)
Secondary	Adverse events experienced	Total adverse events experienced (count of yes answers to excessive fatigue or drowsiness, inability to concentrate, nausea, diarrhea, dizziness, constipation, skin rashes, stomach aches, heartburn, vomiting, euphoria, headache, urinary retention and unintentional weight gain)	Total events recorded each morning and evening after surgery for the first 24 hours post surgery
Secondary	Adverse events experienced	Total adverse events experienced (count of yes answers to excessive fatigue or drowsiness, inability to concentrate, nausea, diarrhea, dizziness, constipation, skin rashes, stomach aches, heartburn, vomiting, euphoria, headache, urinary retention and unintentional weight gain)	Total events recorded each morning and evening after surgery for the first 48 hours post surgery
Secondary	Adverse events experienced	Total adverse events experienced (count of yes answers to excessive fatigue or drowsiness, inability to concentrate, nausea, diarrhea, dizziness, constipation, skin rashes, stomach aches, heartburn, vomiting, euphoria, headache, urinary retention and unintentional weight gain)	Total events recorded each morning and evening for the first 7 days post surgery
Secondary	Pain interference (daily function)	Mean score of Patient-Reported Outcomes Measurement Information System questions related to pain interference: During the post-operative period, how much did pain interfere with your day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always}	Day 2 post surgery (recorded the evening of day 2)
Secondary	Pain interference (daily function)	Mean score of Patient-Reported Outcomes Measurement Information System questions related to pain interference: During the post-operative period, how much did pain interfere with your day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always}	Days 2 and 3 post surgery (recorded the evenings of days 2 and 3)
Secondary	Pain interference (daily function)	Mean score of Patient-Reported Outcomes Measurement Information System questions related to pain interference: During the post-operative period, how much did pain interfere with your day to day activities, work around the home, ability to participate in social activities, enjoyment of life, the things you usually do for fun, enjoyment of social activities, household chores, family life, your ability to concentrate, enjoyment of recreational activities, tasks away from home {scale: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, 5=very much} and How often did pain keep you from socializing with others? {scale=1=never, 2=rarely, 3=sometimes, 4=often, 5=always}	First 7 days post surgery
Secondary	Sleep quality (Questions from PSQ-3)	• Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? {Binary yes/no)	For the first night post surgery
Secondary	Sleep quality (Questions from PSQ-3)	• Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? {Binary yes/no)	For the first 2 nights post surgery
Secondary	Sleep Quality (Questions from PSQ-3)	• Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? {Binary yes/no)	For the first 7 nights post surgery
Secondary	Sleep Quality (PSQ-3)	• Pain and Sleep Questionnaire three-item index : a. Last night did you have trouble falling asleep? b. Last night were you awakened by pain during the night? c. Were you awakened by pain this morning? NRS scale where 0=never, 10=always	Recorded during Visit 2 (Post operative visit 9 days +/-5 days post surgery)
Secondary	Overall satisfaction with sleep	NRS where 0=never, 10=always	For the first 7 evenings post surgery
Secondary	Overall satisfaction with sleep	From PTSS: Rating the overall quality of last night's sleep {NRS where 0=excellent and10=very poor}	For the first 7 evenings post surgery
Secondary	Potential for opioid tablet diversion	Number of returned analgesic capsules at post operative visit (9 days after surgery +/- 5 days)	At post operative visit (9 days after surgery +/- 5 days)