<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/NCT02972502</url>
  </required_header>
  <id_info>
    <org_study_id>13-0078</org_study_id>
    <nct_id>NCT02972502</nct_id>
  </id_info>
  <brief_title>Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department</brief_title>
  <official_title>Investigating the Efficacy of Using Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department: A Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OhioHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OhioHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency&#xD;
      department (ED).In this study the investigators seek to explore another option for treatment&#xD;
      of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol),&#xD;
      a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor&#xD;
      in the brain.&#xD;
&#xD;
      By exploring haloperidol as an option for treatment, the investigators hope to discover a&#xD;
      more efficient and effective medication for the treatment of non-traumatic headaches, thereby&#xD;
      decreasing a patient's length of stay in the department and decreasing the rate of return&#xD;
      visits for continued discomfort from the same headache. This study could lead to the&#xD;
      increased usage of haloperidol as a first line agent in the treatment of prolonged headaches&#xD;
      presenting to the ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At this time, choice of medications for the treatment of headaches in the ED is still based&#xD;
      on personal and patient preferences because no properly constructed trials have been carried&#xD;
      out that would allow identification of a superior agent. Metoclopramide (Reglan) is a common&#xD;
      agent used for relief of headaches in the ED. Uncontrolled studies have shown successful&#xD;
      relief of migraine with metoclopramide of 75%. Further studies have reported success rate of&#xD;
      67% with IV metoclopramide. In this study the investigators seek to explore another option&#xD;
      for treatment of headaches in the ED, one that may be more efficacious and efficient.&#xD;
      Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the&#xD;
      dopamine 2 receptor in the brain. These receptors are relatively abundant in the brainstem&#xD;
      nuclei and sympathetic ganglia and nerves, through which they may regulate autonomic&#xD;
      visceral, gastrointestinal, and hemodynamic responses frequently associated with migraine.&#xD;
      One study, demonstrated that 4 out of 5 patients felt significant relief in pain intensity&#xD;
      with the use of haloperidol, even when other medications had failed. Relapses were rare, and&#xD;
      several patients reported that haloperidol interrupted the prolonged, intractable migraine&#xD;
      spiral they had suffered for days. Furthermore, a case series of six cases of migraine&#xD;
      treated with 5mg of haloperidol IV after a 500 to 1000ml bolus of IV fluids reported complete&#xD;
      or substantial relief within 25 to 65 minutes and side effects were reported as minimal.&#xD;
&#xD;
      The investigators hypothesize that Haloperidol is more efficacious than metoclopramide in the&#xD;
      treatment of an acute headache or migraine in the ED in regard to a self-reported pain rating&#xD;
      scale (Numeric Pain Intensity Scale), need for additional medication, emergency department&#xD;
      return rates, and resolution of symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI lapsed institutional training&#xD;
  </why_stopped>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">April 24, 2017</completion_date>
  <primary_completion_date type="Actual">April 24, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Score According to the Numeric Pain Intensity Scale</measure>
    <time_frame>Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)</time_frame>
    <description>Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for Additional Medications Used in the Emergency Department (ED)</measure>
    <time_frame>48 hours post discharge</time_frame>
    <description>Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge</measure>
    <time_frame>48 hours post discharge</time_frame>
    <description>Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Headache, Migraine</condition>
  <arm_group>
    <arm_group_label>Metoclopramide (Reglan)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haloperidol (Haldol)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metoclopramide</intervention_name>
    <description>Patients receive 10 mg of intravenous (IV) metoclopramide.</description>
    <arm_group_label>Metoclopramide (Reglan)</arm_group_label>
    <other_name>Reglan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Haloperidol</intervention_name>
    <description>Patients receive 2.5 mg of IV haloperidol.</description>
    <arm_group_label>Haloperidol (Haldol)</arm_group_label>
    <other_name>Haldol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>All patients receive a 1-liter bolus of normal saline (NS)</description>
    <arm_group_label>Haloperidol (Haldol)</arm_group_label>
    <arm_group_label>Metoclopramide (Reglan)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diphenhydramine</intervention_name>
    <description>All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
    <arm_group_label>Haloperidol (Haldol)</arm_group_label>
    <arm_group_label>Metoclopramide (Reglan)</arm_group_label>
    <other_name>Benadryl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who present with a headache or migraine with onset less than or equal to 72&#xD;
             hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Breast-feeding women&#xD;
&#xD;
          -  Known history of arrhythmias or QT prolongation (450 ms)&#xD;
&#xD;
          -  Known adverse effects to haloperidol, diphenhydramine (Benadryl) or metoclopramide&#xD;
&#xD;
          -  Subarachnoid hemorrhage&#xD;
&#xD;
          -  Headaches caused by trauma, meningitis&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Parkinson's Disease&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Pheochromocytoma&#xD;
&#xD;
          -  History of glaucoma&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Non-English speaking patients&#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>Christopher Lloyd, D.O.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attending Physician</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OhioHealth Doctors Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <results_first_submitted>August 20, 2018</results_first_submitted>
  <results_first_submitted_qc>September 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 23, 2018</results_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OhioHealth</investigator_affiliation>
    <investigator_full_name>Christopher Lloyd</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <keyword>Metoclopramide (Reglan)</keyword>
  <keyword>Haloperidol (Haldol)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diphenhydramine</mesh_term>
    <mesh_term>Promethazine</mesh_term>
    <mesh_term>Haloperidol</mesh_term>
    <mesh_term>Metoclopramide</mesh_term>
    <mesh_term>Haloperidol decanoate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>May 16, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT02972502/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Metoclopramide (Reglan)</title>
          <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
        </group>
        <group group_id="P2">
          <title>Haloperidol (Haldol)</title>
          <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Haloperidol: Patients receive 2.5 mg of IV haloperidol.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Metoclopramide (Reglan)</title>
          <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
        </group>
        <group group_id="B2">
          <title>Haloperidol (Haldol)</title>
          <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Haloperidol: Patients receive 2.5 mg of IV haloperidol.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</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="31"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.5" spread="9.9"/>
                    <measurement group_id="B2" value="36.9" spread="10.0"/>
                    <measurement group_id="B3" value="35.7" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <population>Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somali</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>Hispanic</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Pain Score</title>
          <description>Baseline Pain Score derived from Numeric Pain Intensity Scale. This scale is a patient-reported numeric measure of pain, from 0 [no pain] to 10 [worst pain imaginable.]</description>
          <population>Study was terminated early. Some baseline information entered for n=49 participants. Data not collected for 11 participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="26"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.13" spread="1.36"/>
                    <measurement group_id="B2" value="8.54" spread="1.34"/>
                    <measurement group_id="B3" value="8.35" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Pain Score According to the Numeric Pain Intensity Scale</title>
        <description>Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.</description>
        <time_frame>Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)</time_frame>
        <population>Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Metoclopramide (Reglan)</title>
            <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
          </group>
          <group group_id="O2">
            <title>Haloperidol (Haldol)</title>
            <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Haloperidol: Patients receive 2.5 mg of IV haloperidol.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Score According to the Numeric Pain Intensity Scale</title>
          <description>Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.</description>
          <population>Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.86" spread="2.37"/>
                    <measurement group_id="O2" value="-5.13" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Need for Additional Medications Used in the Emergency Department (ED)</title>
        <description>Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge</description>
        <time_frame>48 hours post discharge</time_frame>
        <population>Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Metoclopramide (Reglan)</title>
            <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
          </group>
          <group group_id="O2">
            <title>Haloperidol (Haldol)</title>
            <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Haloperidol: Patients receive 2.5 mg of IV haloperidol.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
          </group>
        </group_list>
        <measure>
          <title>Need for Additional Medications Used in the Emergency Department (ED)</title>
          <description>Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge</description>
          <population>Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge</title>
        <description>Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge</description>
        <time_frame>48 hours post discharge</time_frame>
        <population>Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Metoclopramide (Reglan)</title>
            <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
          </group>
          <group group_id="O2">
            <title>Haloperidol (Haldol)</title>
            <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Haloperidol: Patients receive 2.5 mg of IV haloperidol.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
          </group>
        </group_list>
        <measure>
          <title>Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge</title>
          <description>Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge</description>
          <population>Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 hours</time_frame>
      <desc>Study was terminated early. Some information entered for n=49 participants. Data not collected for 11 participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Metoclopramide (Reglan)</title>
          <description>Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</description>
        </group>
        <group group_id="E2">
          <title>Haloperidol (Haldol)</title>
          <description>Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.&#xD;
Haloperidol: Patients receive 2.5 mg of IV haloperidol.&#xD;
Normal Saline: All patients receive a 1-liter bolus of normal saline (NS)&#xD;
Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine.</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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </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>
    <limitations_and_caveats>This study was terminated by the IRB due to PI lapse in required training. Outcomes data reported includes preliminary figures for n=49 patients. Data not collected from 11 patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chelsea Blessing, PhD</name_or_title>
      <organization>OhioHealth Research Institute</organization>
      <phone>(513) 461-1772</phone>
      <email>chelsea.blessing@ohiohealth.com</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/NCT02972502
org study id: 13-0078
nct id: NCT02972502
lead sponsor: 
has dmc: No
Metoclopramide (Reglan) is a common agent used for relief of headaches in the emergency
      department (ED).In this study the investigators seek to explore another option for treatment
      of headaches in the ED, one that may be more efficacious and efficient. Haloperidol (Haldol),
      a butyrophenone class of medication, is thought to act by affecting the dopamine 2 receptor
      in the brain.

      By exploring haloperidol as an option for treatment, the investigators hope to discover a
      more efficient and effective medication for the treatment of non-traumatic headaches, thereby
      decreasing a patient's length of stay in the department and decreasing the rate of return
      visits for continued discomfort from the same headache. This study could lead to the
      increased usage of haloperidol as a first line agent in the treatment of prolonged headaches
      presenting to the ED.
At this time, choice of medications for the treatment of headaches in the ED is still based
      on personal and patient preferences because no properly constructed trials have been carried
      out that would allow identification of a superior agent. Metoclopramide (Reglan) is a common
      agent used for relief of headaches in the ED. Uncontrolled studies have shown successful
      relief of migraine with metoclopramide of 75%. Further studies have reported success rate of
      67% with IV metoclopramide. In this study the investigators seek to explore another option
      for treatment of headaches in the ED, one that may be more efficacious and efficient.
      Haloperidol (Haldol), a butyrophenone class of medication, is thought to act by affecting the
      dopamine 2 receptor in the brain. These receptors are relatively abundant in the brainstem
      nuclei and sympathetic ganglia and nerves, through which they may regulate autonomic
      visceral, gastrointestinal, and hemodynamic responses frequently associated with migraine.
      One study, demonstrated that 4 out of 5 patients felt significant relief in pain intensity
      with the use of haloperidol, even when other medications had failed. Relapses were rare, and
      several patients reported that haloperidol interrupted the prolonged, intractable migraine
      spiral they had suffered for days. Furthermore, a case series of six cases of migraine
      treated with 5mg of haloperidol IV after a 500 to 1000ml bolus of IV fluids reported complete
      or substantial relief within 25 to 65 minutes and side effects were reported as minimal.

      The investigators hypothesize that Haloperidol is more efficacious than metoclopramide in the
      treatment of an acute headache or migraine in the ED in regard to a self-reported pain rating
      scale (Numeric Pain Intensity Scale), need for additional medication, emergency department
      return rates, and resolution of symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Pain Score According to the Numeric Pain Intensity Scale
time frame: Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)
description: Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.
measure: Need for Additional Medications Used in the Emergency Department (ED)
time frame: 48 hours post discharge
description: Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge
measure: Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge
time frame: 48 hours post discharge
description: Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge
arm group label: Metoclopramide (Reglan)
arm group type: Active Comparator
description: Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
arm group label: Haloperidol (Haldol)
arm group type: Experimental
description: Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine.
intervention type: Drug
intervention name: Metoclopramide
description: Patients receive 10 mg of intravenous (IV) metoclopramide.
arm group label: Metoclopramide (Reglan)
other name: Reglan
intervention type: Drug
intervention name: Haloperidol
description: Patients receive 2.5 mg of IV haloperidol.
arm group label: Haloperidol (Haldol)
other name: Haldol
intervention type: Other
intervention name: Normal Saline
description: All patients receive a 1-liter bolus of normal saline (NS)
arm group label: Haloperidol (Haldol)
arm group label: Metoclopramide (Reglan)
intervention type: Drug
intervention name: Diphenhydramine
description: All patients receive 25 mg of intravenous (IV) diphenhydramine.
arm group label: Haloperidol (Haldol)
arm group label: Metoclopramide (Reglan)
other name: Benadryl
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher Lloyd, D.O.
role: Principal Investigator
affiliation: Attending Physician
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OhioHealth
investigator full name: Christopher Lloyd
investigator title: Attending Physician
mesh term: Migraine Disorders
mesh term: Emergencies
mesh term: Headache
mesh term: Diphenhydramine
mesh term: Promethazine
mesh term: Haloperidol
mesh term: Metoclopramide
mesh term: Haloperidol decanoate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated by the IRB due to PI lapse in required training. Outcomes data reported includes preliminary figures for n=49 patients. Data not collected from 11 patients.
point of contact: 