Opioid Analgesic Reduction Study (OARS) - Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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Opioid Analgesic Reduction Study (OARS) - Pilot

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: OPIOID
* Drug: NON-OPIOID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids, Pain Management, Analgesics