Opioid Analgesic Reduction Study

Overview

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.

Full Title of Study: “Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2024

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Opioid
    • Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
  • Active Comparator: Non-Opioid
    • Combination of ibuprofen 400 mg/acetaminophen 500 mg

Clinical Trial Outcome Measures

Primary Measures

  • Brief Pain Inventory pain scale using Numeric Rating Scale
    • Time Frame: the first 24 hours post surgery
    • Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)
  • Brief Pain Inventory pain scale using Numeric Rating Scale
    • Time Frame: the first 48 hours post surgery
    • Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)
  • Brief Pain Inventory pain scale using Numeric Rating Scale
    • Time Frame: the first 7 days post surgery
    • Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)
  • PTSS satisfaction questions assessing overall satisfaction
    • Time Frame: At post operative visit (9 days after surgery +/- 5 days)
    • 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)

Secondary Measures

  • Adverse events experienced
    • Time Frame: Total events recorded each morning and evening after surgery for the first 24 hours post surgery
    • 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)
  • Adverse events experienced
    • Time Frame: Total events recorded each morning and evening after surgery for the first 48 hours post surgery
    • 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)
  • Adverse events experienced
    • Time Frame: Total events recorded each morning and evening for the first 7 days post surgery
    • 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)
  • Pain interference (daily function)
    • Time Frame: Day 2 post surgery (recorded the evening of day 2)
    • 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}
  • Pain interference (daily function)
    • Time Frame: Days 2 and 3 post surgery (recorded the evenings of days 2 and 3)
    • 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}
  • Pain interference (daily function)
    • Time Frame: First 7 days post surgery
    • 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}
  • Sleep quality (Questions from PSQ-3)
    • Time Frame: For the first night post surgery
    • • 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)
  • Sleep quality (Questions from PSQ-3)
    • Time Frame: For the first 2 nights post surgery
    • • 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)
  • Sleep Quality (Questions from PSQ-3)
    • Time Frame: For the first 7 nights post surgery
    • • 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)
  • Sleep Quality (PSQ-3)
    • Time Frame: Recorded during Visit 2 (Post operative visit 9 days +/-5 days post surgery)
    • • 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
  • Overall satisfaction with sleep
    • Time Frame: For the first 7 evenings post surgery
    • NRS where 0=never, 10=always
  • Overall satisfaction with sleep
    • Time Frame: For the first 7 evenings post surgery
    • From PTSS: Rating the overall quality of last night’s sleep {NRS where 0=excellent and10=very poor}
  • Potential for opioid tablet diversion
    • Time Frame: At post operative visit (9 days after surgery +/- 5 days)
    • Number of returned analgesic capsules at post operative visit (9 days after surgery +/- 5 days)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rutgers, The State University of New Jersey
  • Collaborator
    • National Institute of Dental and Craniofacial Research (NIDCR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cecile A. Feldman, DMD, Dean and Professor – Rutgers, The State University of New Jersey
  • Overall Official(s)
    • Cecile A Feldman, DMD, Principal Investigator, Rutgers, The State University of New Jersey
  • Overall Contact(s)
    • Julie Chapman-Greene, PhD, 973-972-3620, chapmaje@sdm.rutgers.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.