Opioid Analgesic Reduction Study

Phase 3

Active, not recruiting

Conditions: Opioid Use

Interventions: Drug: opioid-containing analgesic
Drug: two over-the-counter analgesics

Registration Number: NCT04452344

Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 1815

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid	opioid-containing analgesic	Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
Non-Opioid	two over-the-counter analgesics	Combination of ibuprofen 400 mg/acetaminophen 500 mg

Primary Outcome Measures

Name	Time	Method
Composite Pain 3	End of day of the third day after surgery (day 3) and when waking up the next morning (3rd night after surgery)	Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 3 is the average of all ratings provided two days after surgery (day 3) and when waking up the 3rd morning after surgery (3rd night after surgery).
Pain Average 1	End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)	Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery)
Composite Pain 1	End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)	Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 1 is the average of all ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Composite Pain 2	End of day of the second day after surgery (day 2) and when waking up the next morning (2nd night after surgery)	Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain 2 is the average of all ratings provided day after surgery (day 2) and when waking up the next morning (2nd night after surgery).
Pain Worst 2	End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery	Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)
Pain Average 3	End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)	Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Pain Worst 1	End of day of surgery (day 1) and when waking up the next morning (1 night after surgery)	Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 1 is the average of the ratings provided at the end of day of surgery (day 1) and when waking up the next morning (1 night after surgery).
Overall Satisfaction	At time of post-operative visit (day 9 +/- 5 days)	Participant rating on a five point Likert Scale (1=very satisfied, 2=satisfied, 3=neither satisfied or dissatisfied, 4=dissatisfied, 5=very dissatisfied) to the question: "Overall, how satisfied were you with your current pain medication?"
Pain Worst 3	End of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery)	Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst 3 is the average of the ratings provided at the end of 2nd day of after surgery (day 3) and when waking up the next morning (3rd night after surgery).
Composite Pain All	End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)	Before going to sleep participants are asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the day along with "pain now." Upon waking participants were asked to rate their "worst pain experienced", "least pain experienced" and "average pain experienced" during the night along with "pain now." A NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine was used. Composite Pain All is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Worst All	End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)	Participants are asked to rate the worst pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Worst all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Average All	End of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery)	Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average all is the average of the ratings provided at the end of first 7 days after surgery (days 1 thru 7) and when waking up the first 7 mornings (1st thru 7th nights after surgery).
Pain Average 2	End of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery)	Participants are asked to rate the average pain they experienced during the day (recorded before going to sleep) and overnight (recorded when waking up) on a NRS scale of 0 to 10 where 0=no pain and 10=pain as bad as you can imagine. Pain Average 2 is the average of the ratings provided at the end of day of after surgery (day 2) and when waking up the next morning (2nd night after surgery.)

Secondary Outcome Measures

Name	Time	Method
Pain Interference 3	End of the second full day after surgery (day 3)	Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their 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} Pain Interference 3 is the average ratings provided at the end of 2nd day after surgery (day 3). Lower scores are better.
Sleep 3	When first waking up the 3rd day after surgery	Participants were asked to rate the overall quality of their sleep the 3rd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the third day after surgery.
Number of Participants Receiving Rescue Medication	At post operative visit (9 days after surgery +/- 5 days)	Participant receiving additional pain medication (oxycodone) as study analgesic is not managing pain sufficiently
Sleep 1	When first waking up the day after surgery	Participants were asked to rate the overall quality of their sleep the 1st night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 1 is the rating provided when first waking up the day after surgery.
Pain Interference 2	End of the first full day after surgery (day 2)	Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their 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} Pain Interference 2 is the average ratings provided at the end of day after surgery (day 2). Lower scores are better.
Pain Interference All	First 7 days after surgery	Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their 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} Pain Interference ALL is the average ratings provided at the end of the 1st seven days after surgery (days 1 thru 7). Lower scores are better.
Sleep 2	When first waking up the 2nd day after surgery	Participants were asked to rate the overall quality of their sleep the 2nd night after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep 2 is the rating provided when first waking up the second day after surgery.
Pain Interference 1	End of the day of surgery (day 1)	Participants were asked to rate, on a 5 point Likert Scale, how much did pain interfered with their 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} Pain Interference 1 is the average ratings provided at the end of the day of surgery. Lower scores are better.
Sleep All	First 7 nights after surgery	Participants were asked to rate the overall quality of their sleep for the first 7 nights after surgery on a NRS scale of 0 to 10 where 0=excellent and 10=very poor. Sleep All is the average rating provided for all seven nights.
Potential for Opioid Tablet Diversion	At post operative visit (9 days after surgery +/- 5 days)	Number of returned opioid analgesic capsules at post operative visit (9 days after surgery +/- 5 days)

Trial Locations

Locations (5): University of Maryland
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Baltimore, Maryland, United States
University of Illinois at Chicago
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Chicago, Illinois, United States
University of Rochester
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Rochester, New York, United States
University of Michigan
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Ann Arbor, Michigan, United States
Rutgers School of Dental Medicine
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Newark, New Jersey, United States