<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/NCT03749616</url>
  </required_header>
  <id_info>
    <org_study_id>2009129</org_study_id>
    <nct_id>NCT03749616</nct_id>
  </id_info>
  <brief_title>Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture</brief_title>
  <acronym>Adult NSAID</acronym>
  <official_title>Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <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>
      Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications&#xD;
      for providing pain control in certain patients. There is some data to suggest that NSAIDs can&#xD;
      be used to reduce postoperative pain and narcotic use in patients who had undergone carpal&#xD;
      tunnel release. There are mixed results about the effect of bone healing in adult patients&#xD;
      with broken bones. The investigators hypothesize that NSAID administration in the acute phase&#xD;
      of distal radius fracture healing will be non-inferior for pain control and decrease the use&#xD;
      of opioid analgesics compared to patients who take acetaminophen for pain control during this&#xD;
      same time period. Furthermore, the investigators hypothesize that patients will have similar&#xD;
      or better patient reported outcomes, range of motion, and strength with the administration of&#xD;
      NSAIDs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the United States, drug overdose deaths and opioid-involved deaths continue to increase,&#xD;
      quadrupling since 1999; six out of ten drug overdose deaths involve an opioid. Overdoses from&#xD;
      prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths.&#xD;
      The amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices has&#xD;
      drastically risen, yet there had not been an overall change in the amount of pain that&#xD;
      Americans reported. Deaths from prescription opioids-drugs like oxycodone, hydrocodone, and&#xD;
      methadone-have more than quadrupled since 1999.&#xD;
&#xD;
      Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to control both postoperative&#xD;
      pain and pain associated with some orthopaedic injuries in children and adults with certain&#xD;
      orthopaedic injuries. Further, the use of NSAIDs for pain control has been shown to lessen&#xD;
      the use of narcotic pain medications, the adverse effects of which are well known. With the&#xD;
      current opioid epidemic, more research is needed to determine strategies to reduce opioid use&#xD;
      in patients with orthopaedic injuries. Chapman et al. showed that NSAIDs can be used&#xD;
      effectively to reduce postoperative pain and narcotic use in patients who had undergone&#xD;
      carpal tunnel release. Although distal radius fractures are one of the most common fractures,&#xD;
      no studies have examined the effect of NSAIDs on distal radius fracture pain. The purpose of&#xD;
      this study is to compare pain and narcotic pain medication use in patients who have had&#xD;
      distal radius fractures in patients who use NSAIDs to those who do not.&#xD;
&#xD;
      To the authors' knowledge, there have been no clinical prospective, randomized studies to&#xD;
      evaluate the effect that NSAIDs have on patients with distal radius fractures. The&#xD;
      investigators hypothesize that NSAID administration in the acute phase of distal radius&#xD;
      fracture healing will be non-inferior for pain control and decrease the use of opioid&#xD;
      analgesics compared to patients who take acetaminophen for pain control during this same time&#xD;
      period. Furthermore, the investigators hypothesize that patients will have similar or better&#xD;
      patient reported outcomes, range of motion, and strength with the administration of NSAIDs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2031</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2030</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intensity of pain: Visual Analog Scale (VAS)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of oxycodone tablets</measure>
    <time_frame>2 weeks</time_frame>
    <description>The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extent of Wrist Range of Motion (ROM)</measure>
    <time_frame>3 month</time_frame>
    <description>The patient will be asked to move their wrist and their ROM will be measured with a goniometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Pinch and Grip Strength</measure>
    <time_frame>3 months</time_frame>
    <description>The patient will be asked to grip and pinch a dynamometer to measure grip and pinch strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Pinch Strength</measure>
    <time_frame>3 months</time_frame>
    <description>The patient will be asked to pinch a dynamometer to measure pinch strength.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Distal Radius Fracture</condition>
  <arm_group>
    <arm_group_label>Non-operative Acetaminophen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acetaminophen will be given to participants for pain control following their injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative Acetaminophen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acetaminophen will be given to participants for pain control following their surgery for arm fracture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-operative NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ibuprofen will be given to participants for pain control following their injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Operative NSAID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ibuprofen will be given to participants following their surgery for arm fracture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control</description>
    <arm_group_label>Non-operative NSAID</arm_group_label>
    <arm_group_label>Operative NSAID</arm_group_label>
    <other_name>Motrin</other_name>
    <other_name>Advil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.</description>
    <arm_group_label>Non-operative Acetaminophen</arm_group_label>
    <arm_group_label>Operative Acetaminophen</arm_group_label>
    <other_name>tylenol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Distal radius fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to NSAID use (cannot tolerate, gastritis, ulcers, chronic kidney&#xD;
             disease stage 4 or higher, bleeding disorders/thrombocytopenia)&#xD;
&#xD;
          -  Inability to take breakthrough medications&#xD;
&#xD;
          -  Regular use of NSAIDs&#xD;
&#xD;
          -  Regular use of Narcotics&#xD;
&#xD;
          -  Open fracture&#xD;
&#xD;
          -  Other orthopaedic injuries (polytrauma)&#xD;
&#xD;
          -  Pathologic fracture&#xD;
&#xD;
          -  Previous injury to the bone&#xD;
&#xD;
          -  Pregnant or plan to become pregnant&#xD;
&#xD;
          -  Unable to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jay T Bridgeman, MD, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stacee Clawson</last_name>
    <phone>573-884-9017</phone>
    <email>clawsons@health.missouri.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Missouri Health Care</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>November 22, 2021</last_update_submitted>
  <last_update_submitted_qc>November 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Jay T. Bridgeman, MD</investigator_full_name>
    <investigator_title>Professor, Orthopedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03749616
org study id: 2009129
nct id: NCT03749616
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications
      for providing pain control in certain patients. There is some data to suggest that NSAIDs can
      be used to reduce postoperative pain and narcotic use in patients who had undergone carpal
      tunnel release. There are mixed results about the effect of bone healing in adult patients
      with broken bones. The investigators hypothesize that NSAID administration in the acute phase
      of distal radius fracture healing will be non-inferior for pain control and decrease the use
      of opioid analgesics compared to patients who take acetaminophen for pain control during this
      same time period. Furthermore, the investigators hypothesize that patients will have similar
      or better patient reported outcomes, range of motion, and strength with the administration of
      NSAIDs.
In the United States, drug overdose deaths and opioid-involved deaths continue to increase,
      quadrupling since 1999; six out of ten drug overdose deaths involve an opioid. Overdoses from
      prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths.
      The amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices has
      drastically risen, yet there had not been an overall change in the amount of pain that
      Americans reported. Deaths from prescription opioids-drugs like oxycodone, hydrocodone, and
      methadone-have more than quadrupled since 1999.

      Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to control both postoperative
      pain and pain associated with some orthopaedic injuries in children and adults with certain
      orthopaedic injuries. Further, the use of NSAIDs for pain control has been shown to lessen
      the use of narcotic pain medications, the adverse effects of which are well known. With the
      current opioid epidemic, more research is needed to determine strategies to reduce opioid use
      in patients with orthopaedic injuries. Chapman et al. showed that NSAIDs can be used
      effectively to reduce postoperative pain and narcotic use in patients who had undergone
      carpal tunnel release. Although distal radius fractures are one of the most common fractures,
      no studies have examined the effect of NSAIDs on distal radius fracture pain. The purpose of
      this study is to compare pain and narcotic pain medication use in patients who have had
      distal radius fractures in patients who use NSAIDs to those who do not.

      To the authors' knowledge, there have been no clinical prospective, randomized studies to
      evaluate the effect that NSAIDs have on patients with distal radius fractures. The
      investigators hypothesize that NSAID administration in the acute phase of distal radius
      fracture healing will be non-inferior for pain control and decrease the use of opioid
      analgesics compared to patients who take acetaminophen for pain control during this same time
      period. Furthermore, the investigators hypothesize that patients will have similar or better
      patient reported outcomes, range of motion, and strength with the administration of NSAIDs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intensity of pain: Visual Analog Scale (VAS)
time frame: 2 weeks
description: The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
measure: Number of oxycodone tablets
time frame: 2 weeks
description: The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.
measure: Extent of Wrist Range of Motion (ROM)
time frame: 3 month
description: The patient will be asked to move their wrist and their ROM will be measured with a goniometer.
measure: Quality of Pinch and Grip Strength
time frame: 3 months
description: The patient will be asked to grip and pinch a dynamometer to measure grip and pinch strength.
measure: Quality of Pinch Strength
time frame: 3 months
description: The patient will be asked to pinch a dynamometer to measure pinch strength.
arm group label: Non-operative Acetaminophen
arm group type: Active Comparator
description: Acetaminophen will be given to participants for pain control following their injury.
arm group label: Operative Acetaminophen
arm group type: Active Comparator
description: Acetaminophen will be given to participants for pain control following their surgery for arm fracture.
arm group label: Non-operative NSAID
arm group type: Experimental
description: Ibuprofen will be given to participants for pain control following their injury.
arm group label: Operative NSAID
arm group type: Experimental
description: Ibuprofen will be given to participants following their surgery for arm fracture.
intervention type: Drug
intervention name: Ibuprofen
description: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
arm group label: Non-operative NSAID
arm group label: Operative NSAID
other name: Motrin
other name: Advil
intervention type: Drug
intervention name: Acetaminophen
description: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.
arm group label: Non-operative Acetaminophen
arm group label: Operative Acetaminophen
other name: tylenol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jay T Bridgeman, MD, DDS
role: Principal Investigator
affiliation: University of Missouri-Columbia
last name: Stacee Clawson
phone: 573-884-9017
email: clawsons@health.missouri.edu
facility: 
status: Recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Jay T. Bridgeman, MD
investigator title: Professor, Orthopedic Surgery
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
mesh term: Acetaminophen
mesh term: Ibuprofen