<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452344</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2020002299</org_study_id>
    <secondary_id>1UG3DE028860-01</secondary_id>
    <nct_id>NCT04452344</nct_id>
  </id_info>
  <brief_title>Opioid Analgesic Reduction Study</brief_title>
  <acronym>OARS</acronym>
  <official_title>Opioid Analgesic Reduction Study (OARS): Managing Acute Post-Operative Surgical Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is to provide health care professionals, including dentists, with the best possible&#xD;
      evidence for clinical decision making when deciding upon analgesics for acute post-surgical&#xD;
      pain management, a double-blind, stratified randomized clinical trial will be conducted to&#xD;
      test the hypothesis that a combination of over-the-counter non-opioid containing analgesics&#xD;
      is at least as, if not more, effective (non-inferior) than the most commonly prescribed&#xD;
      opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable&#xD;
      severity of the post-operative pain and generalizability of results.&#xD;
&#xD;
      This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the&#xD;
      impacted 3rd molar extraction pain model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 4, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Pain Inventory pain scale using Numeric Rating Scale</measure>
    <time_frame>the first 24 hours post surgery</time_frame>
    <description>Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory pain scale using Numeric Rating Scale</measure>
    <time_frame>the first 48 hours post surgery</time_frame>
    <description>Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Pain Inventory pain scale using Numeric Rating Scale</measure>
    <time_frame>the first 7 days post surgery</time_frame>
    <description>Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PTSS satisfaction questions assessing overall satisfaction</measure>
    <time_frame>At post operative visit (9 days after surgery +/- 5 days)</time_frame>
    <description>How satisfied are you with the TIME that it takes your pain medication to work? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)&#xD;
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)&#xD;
How satisfied are you with the DURATION of pain relief provided by your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)&#xD;
Overall, how satisfied are you with your pain medication? (5 pt. scale: 1=very satisfied, 5=very dissatisfied)&#xD;
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)&#xD;
Do you think that your pain medication could be more effective in relieving your pain? (5 pt. scale: 1=yes, definitely, 5=definitely not)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events experienced</measure>
    <time_frame>Total events recorded each morning and evening after surgery for the first 24 hours post surgery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events experienced</measure>
    <time_frame>Total events recorded each morning and evening after surgery for the first 48 hours post surgery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events experienced</measure>
    <time_frame>Total events recorded each morning and evening for the first 7 days post surgery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference (daily function)</measure>
    <time_frame>Day 2 post surgery (recorded the evening of day 2)</time_frame>
    <description>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}</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference (daily function)</measure>
    <time_frame>Days 2 and 3 post surgery (recorded the evenings of days 2 and 3)</time_frame>
    <description>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}</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference (daily function)</measure>
    <time_frame>First 7 days post surgery</time_frame>
    <description>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}</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality (Questions from PSQ-3)</measure>
    <time_frame>For the first night post surgery</time_frame>
    <description>• 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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality (Questions from PSQ-3)</measure>
    <time_frame>For the first 2 nights post surgery</time_frame>
    <description>• 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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality (Questions from PSQ-3)</measure>
    <time_frame>For the first 7 nights post surgery</time_frame>
    <description>• 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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality (PSQ-3)</measure>
    <time_frame>Recorded during Visit 2 (Post operative visit 9 days +/-5 days post surgery)</time_frame>
    <description>• 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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction with sleep</measure>
    <time_frame>For the first 7 evenings post surgery</time_frame>
    <description>NRS where 0=never, 10=always</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction with sleep</measure>
    <time_frame>For the first 7 evenings post surgery</time_frame>
    <description>From PTSS: Rating the overall quality of last night's sleep {NRS where 0=excellent and10=very poor}</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential for opioid tablet diversion</measure>
    <time_frame>At post operative visit (9 days after surgery +/- 5 days)</time_frame>
    <description>Number of returned analgesic capsules at post operative visit (9 days after surgery +/- 5 days)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Opioid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Opioid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Combination of ibuprofen 400 mg/acetaminophen 500 mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>opioid-containing analgesic</intervention_name>
    <description>hydrocodone/ acetaminophen combination product</description>
    <arm_group_label>Opioid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>two over-the-counter analgesics</intervention_name>
    <description>combination of over-the-counter analgesics (ibuprofen/acetaminophen)</description>
    <arm_group_label>Non-Opioid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        An individual must meet all of the following criteria to be eligible to participate in the&#xD;
        study:&#xD;
&#xD;
          -  Be able to understand the informed consent.&#xD;
&#xD;
          -  Provide signed and dated informed consent form&#xD;
&#xD;
          -  Be able to understand all directions for data gathering instruments in English&#xD;
&#xD;
          -  Be willing and able to comply with all study procedures and be available for the&#xD;
             duration of the study&#xD;
&#xD;
          -  Planning to undergo extraction of one or more partial or fully impacted mandibular 3rd&#xD;
             molars&#xD;
&#xD;
          -  Be 18 years or older&#xD;
&#xD;
          -  Be in good general health as evidenced by medical history&#xD;
&#xD;
          -  Women must agree to use one of the following methods of contraception while&#xD;
             participating in this study:&#xD;
&#xD;
               -  contraceptive pill&#xD;
&#xD;
               -  intra-uterine device&#xD;
&#xD;
               -  condoms&#xD;
&#xD;
               -  abstinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who self-report the following history will be excluded from participating:&#xD;
&#xD;
          -  History of gastrointestinal bleeding and/or peptic ulcer&#xD;
&#xD;
          -  History of renal disease (excluding kidney stones)&#xD;
&#xD;
          -  History of hepatic disease&#xD;
&#xD;
          -  History of bleeding disorder&#xD;
&#xD;
          -  History of respiratory depression&#xD;
&#xD;
          -  Any prior respiratory effect of an opioid or other anesthetic drugs that required&#xD;
             respiratory support postoperatively&#xD;
&#xD;
          -  Active or untreated asthma&#xD;
&#xD;
          -  History of known allegoric reaction to ibuprofen, acetaminophen, hydrocodone, and/or&#xD;
             anesthesia&#xD;
&#xD;
          -  Currently taking any of the following medications:&#xD;
&#xD;
               -  CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin),&#xD;
                  azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g.,&#xD;
                  ritonavir), which may increase plasma concentrations of hydrocodone bitartrate&#xD;
                  and acetaminophen and prolong opioid adverse reactions, and which may cause&#xD;
                  potentially fatal respiratory depression&#xD;
&#xD;
               -  CNS depressants.&#xD;
&#xD;
          -  Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism&#xD;
&#xD;
          -  History of drug or alcohol abuse&#xD;
&#xD;
          -  Family history of drug or alcohol abuse in a first-degree relative&#xD;
&#xD;
          -  Has had no more than one opioid prescription filled within the past 12 months&#xD;
&#xD;
          -  Currently pregnant or lactating&#xD;
&#xD;
        Participants would also be excluded due to any additional criteria that would place the&#xD;
        individual at increased risk or preclude the individual's full compliance with or&#xD;
        completion of the study which includes:&#xD;
&#xD;
          -  Prior participation in this study&#xD;
&#xD;
          -  Inability or refusal to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecile A Feldman, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers, The State University of New Jersey</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julie Chapman-Greene, PhD</last_name>
    <phone>973-972-3620</phone>
    <email>chapmaje@sdm.rutgers.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Janine Fredericks-Younger, DMD</last_name>
    <phone>973-972-1679</phone>
    <email>frederja@sdm.rutgers.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Miloro, DMD, MD</last_name>
      <phone>312-996-1052</phone>
      <email>mmiloro@uic.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Miloro, DMD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gary Warburton, DDS</last_name>
      <phone>410-706-7060</phone>
      <email>GWarburton@umaryland.edu</email>
    </contact>
    <investigator>
      <last_name>Gary Warburton, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brent Ward, DMD, MD</last_name>
      <phone>734-936-5941</phone>
      <email>bward@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Brent Ward, DMD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rutgers School of Dental Medicine</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincent Zaccardi, DMD, MD</last_name>
      <phone>973-972-7462</phone>
      <email>ziccarvb@sdm.rutgers.edu</email>
    </contact>
    <investigator>
      <last_name>Vincent Zaccardi, DMD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cecile Feldman, DMD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hans Malmstrom, DDS</last_name>
      <phone>585-273-5087</phone>
      <email>Hans_Malmstrom@URMC.Rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Hans Malmstrom, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>April 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Cecile A. Feldman, DMD</investigator_full_name>
    <investigator_title>Dean and Professor</investigator_title>
  </responsible_party>
  <keyword>3rd molar extraction pain model</keyword>
  <keyword>Opioid Analgesics</keyword>
  <keyword>Opioid Diversion</keyword>
  <keyword>Over the counter analgesics</keyword>
  <keyword>Acetaminophen</keyword>
  <keyword>Ibuprofen</keyword>
  <keyword>Hydrocodone</keyword>
  <keyword>Opioid Addiction</keyword>
  <keyword>Pain Management</keyword>
  <keyword>Satisfaction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Electronic Data Capture (EDC) will be used extensively throughout the course of the study for the collection of patient data as well as driving operational/logistical workflows. The database with data dictionary will be available.</ipd_description>
    <ipd_time_frame>12 months after publication</ipd_time_frame>
    <ipd_access_criteria>Request data access from the PI.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT04452344/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452344
org study id: Pro2020002299
secondary id: 1UG3DE028860-01
nct id: NCT04452344
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Brief Pain Inventory pain scale using Numeric Rating Scale
time frame: the first 24 hours post surgery
description: Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)
measure: Brief Pain Inventory pain scale using Numeric Rating Scale
time frame: the first 48 hours post surgery
description: Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)
measure: Brief Pain Inventory pain scale using Numeric Rating Scale
time frame: the first 7 days post surgery
description: Mean score (scale of 0 to 10, 0=no pain, 10=worst imaginable pain)
measure: PTSS satisfaction questions assessing overall satisfaction
time frame: At post operative visit (9 days after surgery +/- 5 days)
description: 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)
measure: Adverse events experienced
time frame: Total events recorded each morning and evening after surgery for the first 24 hours post surgery
description: 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)
measure: Adverse events experienced
time frame: Total events recorded each morning and evening after surgery for the first 48 hours post surgery
description: 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)
measure: Adverse events experienced
time frame: Total events recorded each morning and evening for the first 7 days post surgery
description: 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)
measure: Pain interference (daily function)
time frame: Day 2 post surgery (recorded the evening of day 2)
description: 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}
measure: Pain interference (daily function)
time frame: Days 2 and 3 post surgery (recorded the evenings of days 2 and 3)
description: 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}
measure: Pain interference (daily function)
time frame: First 7 days post surgery
description: 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}
measure: Sleep quality (Questions from PSQ-3)
time frame: For the first night post surgery
description: • 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)
measure: Sleep quality (Questions from PSQ-3)
time frame: For the first 2 nights post surgery
description: • 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)
measure: Sleep Quality (Questions from PSQ-3)
time frame: For the first 7 nights post surgery
description: • 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)
measure: Sleep Quality (PSQ-3)
time frame: Recorded during Visit 2 (Post operative visit 9 days +/-5 days post surgery)
description: • 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
measure: Overall satisfaction with sleep
time frame: For the first 7 evenings post surgery
description: NRS where 0=never, 10=always
measure: Overall satisfaction with sleep
time frame: For the first 7 evenings post surgery
description: From PTSS: Rating the overall quality of last night's sleep {NRS where 0=excellent and10=very poor}
measure: Potential for opioid tablet diversion
time frame: At post operative visit (9 days after surgery +/- 5 days)
description: Number of returned analgesic capsules at post operative visit (9 days after surgery +/- 5 days)
arm group label: Opioid
arm group type: Active Comparator
description: Combination analgesic of hydrocodone 5mg/acetaminophen 300 mg and a placebo pill.
arm group label: Non-Opioid
arm group type: Active Comparator
description: Combination of ibuprofen 400 mg/acetaminophen 500 mg
intervention type: Drug
intervention name: opioid-containing analgesic
description: hydrocodone/ acetaminophen combination product
arm group label: Opioid
intervention type: Drug
intervention name: two over-the-counter analgesics
description: combination of over-the-counter analgesics (ibuprofen/acetaminophen)
arm group label: Non-Opioid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cecile A Feldman, DMD
role: Principal Investigator
affiliation: Rutgers, The State University of New Jersey
last name: Julie Chapman-Greene, PhD
phone: 973-972-3620
email: chapmaje@sdm.rutgers.edu
last name: Janine Fredericks-Younger, DMD
phone: 973-972-1679
email: frederja@sdm.rutgers.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Cecile A. Feldman, DMD
investigator title: Dean and Professor
mesh term: Analgesics
sharing ipd: Yes
ipd description: Electronic Data Capture (EDC) will be used extensively throughout the course of the study for the collection of patient data as well as driving operational/logistical workflows. The database with data dictionary will be available.
ipd time frame: 12 months after publication
ipd access criteria: Request data access from the PI.
provided document: 