<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/NCT03756038</url>
  </required_header>
  <id_info>
    <org_study_id>PRO18090064</org_study_id>
    <nct_id>NCT03756038</nct_id>
  </id_info>
  <brief_title>Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care</brief_title>
  <official_title>Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Pacella</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh Physicians</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The UPMC Mercy Emergency Medicine Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this proposal, the investigators will determine if a single dose of oral lorazepam reduces&#xD;
      distress, pain severity, and need for opiate analgesics both in the ED and in the acute&#xD;
      recovery period after discharge. The investigators will compare the lorazepam arm to a&#xD;
      placebo arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will enroll 120 medically stable adult patients who present to two&#xD;
      emergency departments with a physical injury (&lt; 24 hours ago) and a chief complaint of pain.&#xD;
&#xD;
      The investigators will randomly assign subjects using a blocked randomization schedule to&#xD;
      either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department&#xD;
      providers and patients will be blind to treatment allocation.&#xD;
&#xD;
      All participants will complete measures of negative affect and pain scores at baseline, and&#xD;
      and 1 and 2 hours post-study drug administration. The investigators will record any&#xD;
      analgesics administered in the emergency department until discharge. Patients will also&#xD;
      undergo quantitative sensory testing in the Emergency Department at baseline, and after study&#xD;
      drug administration. At 14-days post-discharge, the investigators will measure summary&#xD;
      reports of pain, mood, and analgesic medication used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    It was not feasible to enroll Emergency Department patients into this protocol&#xD;
  </why_stopped>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">March 27, 2019</completion_date>
  <primary_completion_date type="Actual">March 27, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Severity in the Emergency Department: Numeric Rating Scale</measure>
    <time_frame>The item is anchored to pain intensity &quot;right now&quot; at 60 minutes post-study drug administration</time_frame>
    <description>Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Negative Affect in the Emergency Department</measure>
    <time_frame>The 10 items of the Negative Affect Scale are anchored to mood &quot;right now&quot; at 60 minutes post-study drug administration.</time_frame>
    <description>Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Drug: Oral Lorazepam (1mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug: Oral Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients</description>
    <arm_group_label>Drug: Oral Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lorazepam</intervention_name>
    <description>The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.</description>
    <arm_group_label>Drug: Oral Lorazepam (1mg)</arm_group_label>
    <other_name>Ativan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between the ages of 18-65&#xD;
&#xD;
          -  Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS]&#xD;
             from 0- 10 with anchors of 0 = &quot;no pain&quot; and 10 = &quot;worst pain imaginable&quot;&#xD;
&#xD;
          -  Expected to be in the ED for at least 2 hours, in a private treatment room&#xD;
&#xD;
          -  Ownership of a cell phone with text messaging capabilities&#xD;
&#xD;
          -  Emergency Department admission assessment confirmed subject is not suicidal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Not medically suitable for lorazepam per treating MD (e.g. medical condition where&#xD;
             benzodiazepines are contraindicated or may be unsafe)&#xD;
&#xD;
          -  Not alert and oriented&#xD;
&#xD;
          -  Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by&#xD;
             treating team&#xD;
&#xD;
          -  Seeking treatment due to a mental health or substance use disorder&#xD;
&#xD;
          -  History of chronic opioid use&#xD;
&#xD;
          -  Prescribed opioid or benzodiazepine use within the past 24 hours&#xD;
&#xD;
          -  Alcohol use within the past 12 hours or medical history of alcoholism.&#xD;
&#xD;
          -  Clinical indication for open-label benzodiazepine administration in the ED.&#xD;
&#xD;
          -  Any use of recreational narcotics throughout lifetime&#xD;
&#xD;
          -  Sensitivity or allergy or intolerance to opioids or benzodiazepines&#xD;
&#xD;
          -  Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure&#xD;
             disorder, etc.)&#xD;
&#xD;
          -  Prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria L Pacella, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Presbyterian Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Mercy Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <results_first_submitted>February 7, 2020</results_first_submitted>
  <results_first_submitted_qc>February 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2020</results_first_posted>
  <last_update_submitted>February 26, 2020</last_update_submitted>
  <last_update_submitted_qc>February 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Maria Pacella</investigator_full_name>
    <investigator_title>Research Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lorazepam</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>here is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03756038/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Drug: Oral Lorazepam (1mg)</title>
          <description>Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.&#xD;
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.</description>
        </group>
        <group group_id="P2">
          <title>Drug: Oral Placebo</title>
          <description>Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Due to feasibility issues, we had to prematurely halt enrollment.</population>
      <group_list>
        <group group_id="B1">
          <title>Drug: Oral Lorazepam (1mg)</title>
          <description>Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.&#xD;
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.</description>
        </group>
        <group group_id="B2">
          <title>Drug: Oral Placebo</title>
          <description>Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48" lower_limit="48" upper_limit="48"/>
                    <measurement group_id="B3" value="48" lower_limit="48" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Severity in the Emergency Department: Numeric Rating Scale</title>
        <description>Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)</description>
        <time_frame>The item is anchored to pain intensity &quot;right now&quot; at 60 minutes post-study drug administration</time_frame>
        <population>No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: Oral Lorazepam (1mg)</title>
            <description>Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.&#xD;
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.</description>
          </group>
          <group group_id="O2">
            <title>Drug: Oral Placebo</title>
            <description>Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity in the Emergency Department: Numeric Rating Scale</title>
          <description>Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)</description>
          <population>No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility</population>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Negative Affect in the Emergency Department</title>
        <description>Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.</description>
        <time_frame>The 10 items of the Negative Affect Scale are anchored to mood &quot;right now&quot; at 60 minutes post-study drug administration.</time_frame>
        <population>No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility</population>
        <group_list>
          <group group_id="O1">
            <title>Drug: Oral Lorazepam (1mg)</title>
            <description>Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.&#xD;
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.</description>
          </group>
          <group group_id="O2">
            <title>Drug: Oral Placebo</title>
            <description>Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients</description>
          </group>
        </group_list>
        <measure>
          <title>Negative Affect in the Emergency Department</title>
          <description>Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.</description>
          <population>No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility</population>
          <units>units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2-weeks of study duration</time_frame>
      <desc>There are 0 participants at risk in the placebo arm because no participants were enrolled to that arm.</desc>
      <group_list>
        <group group_id="E1">
          <title>Drug: Oral Lorazepam (1mg)</title>
          <description>Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.&#xD;
Lorazepam: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.</description>
        </group>
        <group group_id="E2">
          <title>Drug: Oral Placebo</title>
          <description>Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Maria Pacella</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-647-3183</phone>
      <email>pacellam@upmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03756038
org study id: PRO18090064
nct id: NCT03756038
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces
      distress, pain severity, and need for opiate analgesics both in the ED and in the acute
      recovery period after discharge. The investigators will compare the lorazepam arm to a
      placebo arm.
The investigators will enroll 120 medically stable adult patients who present to two
      emergency departments with a physical injury (< 24 hours ago) and a chief complaint of pain.

      The investigators will randomly assign subjects using a blocked randomization schedule to
      either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department
      providers and patients will be blind to treatment allocation.

      All participants will complete measures of negative affect and pain scores at baseline, and
      and 1 and 2 hours post-study drug administration. The investigators will record any
      analgesics administered in the emergency department until discharge. Patients will also
      undergo quantitative sensory testing in the Emergency Department at baseline, and after study
      drug administration. At 14-days post-discharge, the investigators will measure summary
      reports of pain, mood, and analgesic medication used.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain Severity in the Emergency Department: Numeric Rating Scale
time frame: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
description: Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
measure: Negative Affect in the Emergency Department
time frame: The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.
description: Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.
arm group label: Drug: Oral Lorazepam (1mg)
arm group type: Experimental
description: Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
arm group label: Drug: Oral Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Placebos
description: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
arm group label: Drug: Oral Placebo
intervention type: Drug
intervention name: Lorazepam
description: The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
arm group label: Drug: Oral Lorazepam (1mg)
other name: Ativan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Maria L Pacella, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Maria Pacella
investigator title: Research Assistant Professor
mesh term: Emergencies
mesh term: Acute Pain
mesh term: Lorazepam
sharing ipd: Undecided
ipd description: here is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 