xml: <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/NCT05967442</url>
    </required_header>
    <id_info>
      <org_study_id>AHC-7192-D5000322</org_study_id>
      <nct_id>NCT05967442</nct_id>
    </id_info>
    <brief_title>Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines</brief_title>
    <acronym>MAGraine</acronym>
    <official_title>A Randomized, Placebo-Controlled, Double-Blind Study of the Effects of Magnesium Compared to Conventional Therapy on Acute Migraine</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Advocate Health Care</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Advocate Health Care</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This investigation describes a proposed clinical trial that will evaluate the relative&#xD;
        efficacy of intravenous magnesium sulfate for the treatment of migraine compared to&#xD;
        intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the&#xD;
        treatment of acute headache and migraine in adult patients. The ultimate objective will be&#xD;
        clinical application of these drugs in the emergency department for the treatment of acute&#xD;
        headache and migraine.&#xD;
  &#xD;
        The two phenothiazines (metoclopramide and prochlorperazine) have been routinely utilized in&#xD;
        the treatment of acute headache and migraine in the emergency department setting. Per the&#xD;
        2017 American Headache Society guidelines, both intravenous metoclopramide and intravenous&#xD;
        procholorperazine are recommended as &quot;clinicians should offer&quot; agents with level B evidence.&#xD;
        Of note, there are no agents with level A evidence purported by this guideline for acute&#xD;
        management of migraine. The same guideline offers &quot;no recommendation can be made regarding&#xD;
        the role of intravenous magnesium for adults who present to the ED with acute migraine.&#xD;
        However intravenous magnesium may be of benefit to patients who present with migraine with&#xD;
        aura.&quot; Multiple trials have evaluated intravenous magnesium's safety and efficacy in the&#xD;
        management of acute migraine. These have demonstrated the tolerability of intravenous&#xD;
        magnesium on a with breadth of patients. Most commonly the primary adverse event was flushing&#xD;
        which self-resolved. No cases of hypotension were reported.&#xD;
  &#xD;
        None of these study agents have been withdrawn from the market.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Migraine or severe headache affected one-fifth of women and one-tenth of men in 2015 and is&#xD;
        one of the leading causes of disability in the world. Over one million visits to emergency&#xD;
        departments (ED) in the US are due to migraines. Migraine, previously believed to be a&#xD;
        vascular disorder, is caused by inflammation due to vasodilation in the meninges secondary to&#xD;
        the release of vasoactive neuropeptides by stimulation of the trigeminal nerve. This&#xD;
        inflammation can result in symptoms such as headache, nausea, vomiting, dizziness,&#xD;
        photophobia and phonophobia.&#xD;
  &#xD;
        Despite migraine being a common disorder, there has yet to be a cure. Several classes of&#xD;
        medications have been studied for the treatment of migraine. Recently, conventional therapy&#xD;
        has shifted to the use of antidopaminergics including prochlorperazine, metoclopramide and&#xD;
        haloperidol, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen,&#xD;
        and triptans, sumatriptan being the most commonly utilized. 5Although intravenous opioids&#xD;
        have historically been the most common treatment for migraines, their use has fallen out of&#xD;
        favor due to their association with increased recurrence of headaches and ED visits, abuse&#xD;
        potential, and most recently severe intravenous opiate shortage. Alternative treatments&#xD;
        include ketamine, propofol, dihydroergotamine and magnesium.&#xD;
  &#xD;
        Magnesium is an intracellular cation that has been associated with both the function of&#xD;
        serotonin and regulation of vascular tone, which are both mechanisms that implicate its role&#xD;
        in the treatment of migraine. Intravenous magnesium sulfate has been studied as a treatment&#xD;
        for migraine compared to placebo, metoclopramide and prochlorperazine. These studies have&#xD;
        shown that magnesium is well-tolerated with a good safety profile and may be efficacious in&#xD;
        the treatment of migraine. Metoclopramide, prochlorperazine and magnesium have been&#xD;
        recommended in clinical practice guidelines and have become routine standard of care for&#xD;
        treatment of migraine in this emergency department. However, no trial has evaluated these&#xD;
        modalities simultaneously in the same population. The purpose of our study is to compare the&#xD;
        relative efficacy for magnesium, metoclopramide, and prochlorperazine in the treatment of&#xD;
        headache and migraine.&#xD;
  &#xD;
        Patients presenting to Advocate Christ Medical Center emergency department with a diagnosis&#xD;
        of migraine or headache from October 1, 2018 to April 1, 2020 seven days a week from 6am to&#xD;
        1:30am. The emergency department physician will identify patients eligible for the study and&#xD;
        alert the emergency medicine pharmacist who will consent the patient using the HRP-502 Form&#xD;
        (attached). Each patient will be handed a copy of the consent form and signed consent forms&#xD;
        will be kept at Advocate Christ Medical Center in the pharmacy resident's locked office.&#xD;
  &#xD;
        Via monthly block randomization, patients will be given one of three guideline recommended&#xD;
        study drugs. Allocation will be concealed by a pharmacist (not participating in the rest of&#xD;
        the study) solely designated to choose which drug will be the assigned study drug for each&#xD;
        month. The pharmacists, physicians, and nurses participating in administration of the&#xD;
        medications will be blinded to which drug is being administered during each month.&#xD;
        Metoclopramide, prochlorperazine and magnesium have been recommended in clinical practice&#xD;
        guidelines and have become routine standard of care for treatment of migraine in this&#xD;
        emergency department. All three study drugs will be stored in the investigational medication&#xD;
        refrigerator located in the main pharmacy. A pharmacist on duty in the emergency department&#xD;
        will obtain the medication from the refrigerator and deliver it to the bedside nurse who is&#xD;
        actively caring for the patient after an order from the physician.&#xD;
  &#xD;
        Magnesium 2gm/50mL D5W will be administered as an intravenous bolus over 20 minutes.&#xD;
        Prochlorperazine 10mg/50mL D5W will be administered as an intravenous bolus over 20 minutes.&#xD;
        Metoclopramide 10mg/50mL D5W will be administered as an intravenous bolus over 20 minutes.&#xD;
  &#xD;
        The primary outcome of this study will be mean change in pain from baseline to 30 minutes&#xD;
        after initiation of infusion (as defined on a 11-point Numeric Rating Scale. Secondary&#xD;
        endpoints include mean change in pain from baseline to 60 minutes and 120 minutes after&#xD;
        initiation of infusion (as defined on a 11-point Numeric Rating Scale), time to emergency&#xD;
        department discharge, and adverse effects due to administration of study drug (hypotension,&#xD;
        flushing, akathisia, dystonia, nausea, vomiting, dizziness, drowsiness, other self-reported&#xD;
        adverse effects).&#xD;
  &#xD;
        The following data points will be collected: financial identification number (FIN), age,&#xD;
        gender, race, weight, height, initial vitals (heart rate, blood pressure, respiratory rate,&#xD;
        temperature, and oxygen saturation), past medical history, medications taken prior to&#xD;
        arrival, hospital length of stay, rescue medications given for extrapyramidal side effects or&#xD;
        pain due to treatment failure (including dose, route and time to administration of rescue&#xD;
        medication).&#xD;
  &#xD;
        All data will be collected without patient identifiers and confidentiality will be&#xD;
        maintained. Furthermore, information will be kept on a password protected computer located at&#xD;
        Advocate Christ Medical Center in the pharmacy resident's locked office. The recorded data&#xD;
        will be destroyed following completion of study and analysis of data.&#xD;
  &#xD;
        The following study variables will be collected based on the study objectives:&#xD;
  &#xD;
          -  FIN (for identification of patients in Care Connection only)&#xD;
  &#xD;
          -  Age&#xD;
  &#xD;
          -  Gender&#xD;
  &#xD;
          -  Race&#xD;
  &#xD;
          -  Weight&#xD;
  &#xD;
          -  Height&#xD;
  &#xD;
          -  Initial vitals (heart rate, blood pressure, respiratory rate, temperature and oxygen&#xD;
             saturation)&#xD;
  &#xD;
          -  Past Medical History&#xD;
  &#xD;
          -  Antimigraine medications taken prior to arrival (i.e: acetaminophen, NSAIDs, opiates,&#xD;
             triptans, Fioricet, ergots, metoclopramide, magnesium, prochlorperazine,&#xD;
             antimuscarinics, propranolol)&#xD;
  &#xD;
          -  Hospital length of stay&#xD;
  &#xD;
          -  Rescue medications given for treatment failure (i.e: acetaminophen, NSAIDs, opiates,&#xD;
             triptans, Fioricet, ergots, metoclopramide, magnesium, prochlorperazine,&#xD;
             antimuscarinics, propranolol) or for extrapyramidal side effects (diphenhydramine or&#xD;
             benztropine)&#xD;
  &#xD;
          -  Dose and route of rescue medications given&#xD;
  &#xD;
          -  Time to administration of rescue medication&#xD;
  &#xD;
        All data will be collected without patient identifiers and confidentiality will be&#xD;
        maintained. Furthermore, information will be kept on a password protected computer located at&#xD;
        Advocate Christ Medical Center in the pharmacy resident's locked office. The recorded data&#xD;
        will be destroyed following completion of study and analysis of data. Data collection and&#xD;
        analysis will only be conducted by the members of the research team. If data is needed to&#xD;
        transported, it will only be done by the research team and will only be transported between&#xD;
        team members. Transfer of data will be done person to person or electronically via a password&#xD;
        protected drive.&#xD;
  &#xD;
        All information gathered during this study will be kept confidential. Study data will be&#xD;
        managed using REDCap16 electronic data capture tools hosted by Advocate Health Care. REDCap&#xD;
        (Research Electronic Data Capture) is a secure, web-based application designed to support&#xD;
        data capture for research studies, providing 1) an intuitive interface for validated data&#xD;
        entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated&#xD;
        export procedures for seamless data downloads to common statistical packages; and 4)&#xD;
        procedures for importing data from external sources. The data will be accessible to only the&#xD;
        study investigators and REDCap administrators. Subjects will be assigned case numbers. Data&#xD;
        being extracted from the REDCap database will include only the case numbers and be&#xD;
        de-identified via the electronic removal of PHI prior to data download. After data collection&#xD;
        is complete and records have been verified, identifiers will be permanently removed from the&#xD;
        data set. Any study documentation including regulatory information, consent forms, and data&#xD;
        collection forms will be secured in a locked cabinet in the pharmacy resident's locked office&#xD;
        and will be destroyed upon completion of the study and analysis of the data.&#xD;
  &#xD;
        A maximum of 264 subjects (88 subjects treated with magnesium, 88 subjects treated with&#xD;
        metoclopramide, and 88 subjects treated with prochlorperazine) will be included in this&#xD;
        prospective randomized study based on estimates of patients presenting to the Emergency&#xD;
        Department with a primary diagnosis of headache or migraine at Advocate Christ Medical Center&#xD;
        from past years. With this sample size, a 80% power to detect a mean difference of 1.4 points&#xD;
        between groups for the primary outcome of mean Numeric Rating Scale with an alpha of 0.05.&#xD;
  &#xD;
        Descriptive statistics will be calculated for all variables and presented overall and by&#xD;
        group using mean ± SD for continuous variables and count/percentages for categorical&#xD;
        variables. Comparisons will be made between groups for all outcomes using Chi-Square or&#xD;
        Fisher's exact tests as necessary for categorical data and a one-way ANOVA as appropriate for&#xD;
        all continuous data. All tests will be two-tailed and a p-value of 0.05 will be considered&#xD;
        statistically significant in all analyses. Also to be discussed assess utilizing multiple&#xD;
        predictive multivariate logistic regression models.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 23, 2019</start_date>
    <completion_date type="Actual">April 6, 2023</completion_date>
    <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>30min pain score</measure>
      <time_frame>30 minutes after initiation</time_frame>
      <description>11 point Numerical Rating Scale pain score at 30 minutes after initiation of drug</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>LOS</measure>
      <time_frame>Upon discharge</time_frame>
      <description>Emergency Department Length of stay. Measured from time of arrival to time of discharged documented in the electronic medical record. Duration measured in minutes</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">288</enrollment>
    <condition>Migraine</condition>
    <condition>Headache</condition>
    <arm_group>
      <arm_group_label>Magnesium</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Metoclopramide</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Metoclopramide 10mg in 50ml D5W over 20 minutes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prochlorperazine</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Prochlorperazine in 50ml D5W over 20 minutes</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Magnesium Sulfate</intervention_name>
      <description>Magnesium Sulfate 2gm in 50ml D5W over 20 minutes</description>
      <arm_group_label>Magnesium</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metoclopramide 10mg</intervention_name>
      <description>Metoclopramide 10mg in 50ml D5W over 20 minutes</description>
      <arm_group_label>Metoclopramide</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Prochlorperazine (Compazine) Injection</intervention_name>
      <description>Prochlorperazine 10mg in 50ml D5W over 20 minutes</description>
      <arm_group_label>Prochlorperazine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years or older&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
            -  Primary diagnosis of headache or migraine&#xD;
  &#xD;
            -  Between October 1, 2018 to April 1, 2020&#xD;
  &#xD;
            -  Presenting to Advocate Christ Medical Center emergency department and meet clinical&#xD;
               assessment per physician&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy defined as a positive urine HCG&#xD;
  &#xD;
            -  Stated history of renal impairment&#xD;
  &#xD;
            -  Allergy or sensitivity to any study drugs&#xD;
  &#xD;
            -  Concomitant treatment at the time of study drug administered in the emergency&#xD;
               department&#xD;
  &#xD;
            -  Patients with a history of this study participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Advocate Christ Medical Center</name>
        <address>
          <city>Oak Lawn</city>
          <state>Illinois</state>
          <zip>60453</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 9, 2020</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Advocate Health Care</investigator_affiliation>
      <investigator_full_name>Marc Mcdowell</investigator_full_name>
      <investigator_title>Principle investigator</investigator_title>
    </responsible_party>
    <keyword>magnesium</keyword>
    <keyword>migraine</keyword>
    <keyword>headache</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Migraine Disorders</mesh_term>
      <mesh_term>Headache</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Magnesium Sulfate</mesh_term>
      <mesh_term>Metoclopramide</mesh_term>
      <mesh_term>Prochlorperazine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967442
  org study id: AHC-7192-D5000322
  nct id: NCT05967442
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This investigation describes a proposed clinical trial that will evaluate the relative
        efficacy of intravenous magnesium sulfate for the treatment of migraine compared to
        intravenous metoclopramide (Reglan) and intravenous prochlorperazine (Compazine) in the
        treatment of acute headache and migraine in adult patients. The ultimate objective will be
        clinical application of these drugs in the emergency department for the treatment of acute
        headache and migraine.
  
        The two phenothiazines (metoclopramide and prochlorperazine) have been routinely utilized in
        the treatment of acute headache and migraine in the emergency department setting. Per the
        2017 American Headache Society guidelines, both intravenous metoclopramide and intravenous
        procholorperazine are recommended as "clinicians should offer" agents with level B evidence.
        Of note, there are no agents with level A evidence purported by this guideline for acute
        management of migraine. The same guideline offers "no recommendation can be made regarding
        the role of intravenous magnesium for adults who present to the ED with acute migraine.
        However intravenous magnesium may be of benefit to patients who present with migraine with
        aura." Multiple trials have evaluated intravenous magnesium's safety and efficacy in the
        management of acute migraine. These have demonstrated the tolerability of intravenous
        magnesium on a with breadth of patients. Most commonly the primary adverse event was flushing
        which self-resolved. No cases of hypotension were reported.
  
        None of these study agents have been withdrawn from the market.
  Migraine or severe headache affected one-fifth of women and one-tenth of men in 2015 and is
        one of the leading causes of disability in the world. Over one million visits to emergency
        departments (ED) in the US are due to migraines. Migraine, previously believed to be a
        vascular disorder, is caused by inflammation due to vasodilation in the meninges secondary to
        the release of vasoactive neuropeptides by stimulation of the trigeminal nerve. This
        inflammation can result in symptoms such as headache, nausea, vomiting, dizziness,
        photophobia and phonophobia.
  
        Despite migraine being a common disorder, there has yet to be a cure. Several classes of
        medications have been studied for the treatment of migraine. Recently, conventional therapy
        has shifted to the use of antidopaminergics including prochlorperazine, metoclopramide and
        haloperidol, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen,
        and triptans, sumatriptan being the most commonly utilized. 5Although intravenous opioids
        have historically been the most common treatment for migraines, their use has fallen out of
        favor due to their association with increased recurrence of headaches and ED visits, abuse
        potential, and most recently severe intravenous opiate shortage. Alternative treatments
        include ketamine, propofol, dihydroergotamine and magnesium.
  
        Magnesium is an intracellular cation that has been associated with both the function of
        serotonin and regulation of vascular tone, which are both mechanisms that implicate its role
        in the treatment of migraine. Intravenous magnesium sulfate has been studied as a treatment
        for migraine compared to placebo, metoclopramide and prochlorperazine. These studies have
        shown that magnesium is well-tolerated with a good safety profile and may be efficacious in
        the treatment of migraine. Metoclopramide, prochlorperazine and magnesium have been
        recommended in clinical practice guidelines and have become routine standard of care for
        treatment of migraine in this emergency department. However, no trial has evaluated these
        modalities simultaneously in the same population. The purpose of our study is to compare the
        relative efficacy for magnesium, metoclopramide, and prochlorperazine in the treatment of
        headache and migraine.
  
        Patients presenting to Advocate Christ Medical Center emergency department with a diagnosis
        of migraine or headache from October 1, 2018 to April 1, 2020 seven days a week from 6am to
        1:30am. The emergency department physician will identify patients eligible for the study and
        alert the emergency medicine pharmacist who will consent the patient using the HRP-502 Form
        (attached). Each patient will be handed a copy of the consent form and signed consent forms
        will be kept at Advocate Christ Medical Center in the pharmacy resident's locked office.
  
        Via monthly block randomization, patients will be given one of three guideline recommended
        study drugs. Allocation will be concealed by a pharmacist (not participating in the rest of
        the study) solely designated to choose which drug will be the assigned study drug for each
        month. The pharmacists, physicians, and nurses participating in administration of the
        medications will be blinded to which drug is being administered during each month.
        Metoclopramide, prochlorperazine and magnesium have been recommended in clinical practice
        guidelines and have become routine standard of care for treatment of migraine in this
        emergency department. All three study drugs will be stored in the investigational medication
        refrigerator located in the main pharmacy. A pharmacist on duty in the emergency department
        will obtain the medication from the refrigerator and deliver it to the bedside nurse who is
        actively caring for the patient after an order from the physician.
  
        Magnesium 2gm/50mL D5W will be administered as an intravenous bolus over 20 minutes.
        Prochlorperazine 10mg/50mL D5W will be administered as an intravenous bolus over 20 minutes.
        Metoclopramide 10mg/50mL D5W will be administered as an intravenous bolus over 20 minutes.
  
        The primary outcome of this study will be mean change in pain from baseline to 30 minutes
        after initiation of infusion (as defined on a 11-point Numeric Rating Scale. Secondary
        endpoints include mean change in pain from baseline to 60 minutes and 120 minutes after
        initiation of infusion (as defined on a 11-point Numeric Rating Scale), time to emergency
        department discharge, and adverse effects due to administration of study drug (hypotension,
        flushing, akathisia, dystonia, nausea, vomiting, dizziness, drowsiness, other self-reported
        adverse effects).
  
        The following data points will be collected: financial identification number (FIN), age,
        gender, race, weight, height, initial vitals (heart rate, blood pressure, respiratory rate,
        temperature, and oxygen saturation), past medical history, medications taken prior to
        arrival, hospital length of stay, rescue medications given for extrapyramidal side effects or
        pain due to treatment failure (including dose, route and time to administration of rescue
        medication).
  
        All data will be collected without patient identifiers and confidentiality will be
        maintained. Furthermore, information will be kept on a password protected computer located at
        Advocate Christ Medical Center in the pharmacy resident's locked office. The recorded data
        will be destroyed following completion of study and analysis of data.
  
        The following study variables will be collected based on the study objectives:
  
          -  FIN (for identification of patients in Care Connection only)
  
          -  Age
  
          -  Gender
  
          -  Race
  
          -  Weight
  
          -  Height
  
          -  Initial vitals (heart rate, blood pressure, respiratory rate, temperature and oxygen
             saturation)
  
          -  Past Medical History
  
          -  Antimigraine medications taken prior to arrival (i.e: acetaminophen, NSAIDs, opiates,
             triptans, Fioricet, ergots, metoclopramide, magnesium, prochlorperazine,
             antimuscarinics, propranolol)
  
          -  Hospital length of stay
  
          -  Rescue medications given for treatment failure (i.e: acetaminophen, NSAIDs, opiates,
             triptans, Fioricet, ergots, metoclopramide, magnesium, prochlorperazine,
             antimuscarinics, propranolol) or for extrapyramidal side effects (diphenhydramine or
             benztropine)
  
          -  Dose and route of rescue medications given
  
          -  Time to administration of rescue medication
  
        All data will be collected without patient identifiers and confidentiality will be
        maintained. Furthermore, information will be kept on a password protected computer located at
        Advocate Christ Medical Center in the pharmacy resident's locked office. The recorded data
        will be destroyed following completion of study and analysis of data. Data collection and
        analysis will only be conducted by the members of the research team. If data is needed to
        transported, it will only be done by the research team and will only be transported between
        team members. Transfer of data will be done person to person or electronically via a password
        protected drive.
  
        All information gathered during this study will be kept confidential. Study data will be
        managed using REDCap16 electronic data capture tools hosted by Advocate Health Care. REDCap
        (Research Electronic Data Capture) is a secure, web-based application designed to support
        data capture for research studies, providing 1) an intuitive interface for validated data
        entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated
        export procedures for seamless data downloads to common statistical packages; and 4)
        procedures for importing data from external sources. The data will be accessible to only the
        study investigators and REDCap administrators. Subjects will be assigned case numbers. Data
        being extracted from the REDCap database will include only the case numbers and be
        de-identified via the electronic removal of PHI prior to data download. After data collection
        is complete and records have been verified, identifiers will be permanently removed from the
        data set. Any study documentation including regulatory information, consent forms, and data
        collection forms will be secured in a locked cabinet in the pharmacy resident's locked office
        and will be destroyed upon completion of the study and analysis of the data.
  
        A maximum of 264 subjects (88 subjects treated with magnesium, 88 subjects treated with
        metoclopramide, and 88 subjects treated with prochlorperazine) will be included in this
        prospective randomized study based on estimates of patients presenting to the Emergency
        Department with a primary diagnosis of headache or migraine at Advocate Christ Medical Center
        from past years. With this sample size, a 80% power to detect a mean difference of 1.4 points
        between groups for the primary outcome of mean Numeric Rating Scale with an alpha of 0.05.
  
        Descriptive statistics will be calculated for all variables and presented overall and by
        group using mean ± SD for continuous variables and count/percentages for categorical
        variables. Comparisons will be made between groups for all outcomes using Chi-Square or
        Fisher's exact tests as necessary for categorical data and a one-way ANOVA as appropriate for
        all continuous data. All tests will be two-tailed and a p-value of 0.05 will be considered
        statistically significant in all analyses. Also to be discussed assess utilizing multiple
        predictive multivariate logistic regression models.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: 30min pain score
  time frame: 30 minutes after initiation
  description: 11 point Numerical Rating Scale pain score at 30 minutes after initiation of drug
  measure: LOS
  time frame: Upon discharge
  description: Emergency Department Length of stay. Measured from time of arrival to time of discharged documented in the electronic medical record. Duration measured in minutes
  arm group label: Magnesium
  arm group type: Experimental
  arm group label: Metoclopramide
  arm group type: Active Comparator
  description: Metoclopramide 10mg in 50ml D5W over 20 minutes
  arm group label: Prochlorperazine
  arm group type: Active Comparator
  description: Prochlorperazine in 50ml D5W over 20 minutes
  intervention type: Drug
  intervention name: Magnesium Sulfate
  description: Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
  arm group label: Magnesium
  intervention type: Drug
  intervention name: Metoclopramide 10mg
  description: Metoclopramide 10mg in 50ml D5W over 20 minutes
  arm group label: Metoclopramide
  intervention type: Drug
  intervention name: Prochlorperazine (Compazine) Injection
  description: Prochlorperazine 10mg in 50ml D5W over 20 minutes
  arm group label: Prochlorperazine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Advocate Health Care
  investigator full name: Marc Mcdowell
  investigator title: Principle investigator
  mesh term: Migraine Disorders
  mesh term: Headache
  mesh term: Magnesium Sulfate
  mesh term: Metoclopramide
  mesh term: Prochlorperazine
  sharing ipd: No