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/NCT05983354</url>
    </required_header>
    <id_info>
      <org_study_id>23-016</org_study_id>
      <nct_id>NCT05983354</nct_id>
    </id_info>
    <brief_title>Oral Medications for the Management of Acute Migraine Headache in the Emergency Department</brief_title>
    <official_title>Oral v. Parenteral Medications for the Emergency Management of Acute Migraine: a Pilot Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Health Sciences North Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Health Sciences North Research Institute</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot randomized control trial is to assess the feasibility of our patient&#xD;
        recruitment and data collection strategy ahead of a full scale RCT investigating the efficacy&#xD;
        of oral v. parenteral medications in the management of acute migraine headaches in the&#xD;
        emergency department. Patients will be randomly assigned to receive either (A) standard&#xD;
        medical therapy for the treatment of acute migraine headache (metoclopramide and ketorolac&#xD;
        IV) and oral placebo or (B) oral metoclopramide and ibuprofen with normal saline IV. Primary&#xD;
        outcome measures are recruitment rate and improvement in pain score at 60 minutes from&#xD;
        medication administration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives&#xD;
  &#xD;
        The planned study is a pilot study designed to assess the feasibility of our recruitment and&#xD;
        data collection strategy. The primary feasibility outcome will be recruitment rate, which is&#xD;
        defined as the proportion of eligible patients approached who are successfully recruited over&#xD;
        the proposed 6-month pilot study period. Our secondary feasibility outcomes are (a)&#xD;
        proportion of eligible patients approached and (b) rate of attrition during the study period.&#xD;
  &#xD;
        Our preliminary primary outcome will be improvement in pain from baseline to 60 minutes after&#xD;
        medication administration using the visual analogue scale (Bijur et al. 2008). Preliminary&#xD;
        secondary outcomes will include headache relief and freedom from headache at 2 h, the need&#xD;
        for rescue medication, ED length of stay and return to ED within 24h of discharge. We will&#xD;
        also assess frequency of adverse effects commonly associated with study medications,&#xD;
        including gastrointestinal upset, patient-reported restlessness or dystonic reaction, and&#xD;
        fatigue.&#xD;
  &#xD;
        Design&#xD;
  &#xD;
        In this parallel, noninferiority, double-blind randomised control pilot study, eligible&#xD;
        patients presenting to the emergency department with a chief complaint of headache will be&#xD;
        randomly assigned with an allocation ratio of 1:1 to receive one of 2 treatments: intravenous&#xD;
        ketorolac (10 mg) and metoclopramide (10 mg) v. oral ibuprofen (400 mg) and metoclopramide&#xD;
        (10 mg). Dosing was selected to reflect the lowest effective doses recommended for emergency&#xD;
        department management of migraine headaches (Friedman et al. 2011, Motov et al. 2017). The&#xD;
        study will last 6 months at which time it will stop.&#xD;
  &#xD;
        Study population&#xD;
  &#xD;
        Patients between the ages of 18 and 64 presenting to the ED with a chief complaint of&#xD;
        headache will be eligible to participate in the study. Exclusion criteria include vomiting or&#xD;
        inability to tolerate oral medications at the time of medication administration, focal&#xD;
        neurologic symptoms, head trauma within 14 days, history of renal disease, contraindication&#xD;
        to NSAIDs including pregnancy or concurrent use of blood thinners, hypersensitivity reaction&#xD;
        to any of the study medications, or &gt;15 headache days per month.&#xD;
  &#xD;
        Study procedures&#xD;
  &#xD;
        Treatment will be assigned using a random number generator. Contents of treatment, which will&#xD;
        be identical in appearance, will be known only to the research pharmacist and this&#xD;
        information will be stored remotely from the ED. Administering nurses and treating physicians&#xD;
        will be blind to the treatment group, as will patients and research assistants collecting&#xD;
        outcome data.&#xD;
  &#xD;
        Data collection&#xD;
  &#xD;
        Data will be collected using patient interviews immediately prior to medication&#xD;
        administration and repeated at 1 and 2 hours after medication administration. A chart review&#xD;
        will then be conducted to check for return visits within 24 h of ED discharge.&#xD;
  &#xD;
        Enrolment:&#xD;
  &#xD;
        Based on sample size calculations, we plan to enrol 55 patients.&#xD;
  &#xD;
        Statistical procedures:&#xD;
  &#xD;
        Primary and secondary feasibility outcomes will be reported as the proportion of patients&#xD;
        approached who were recruited, proportion of eligible patients approached and the proportion&#xD;
        who withdrew consent during the study period +/- 95% CI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</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>
      <masking_description>Treatment will be randomly assigned using a random number generator by an independent research assistant who is not involved in data collection. Contents of treatment will be known only to the research pharmacist and this information will be stored remotely from the ED; patients, administering nurses and treating physicians will be blind to the treatment group, as well the research assistants collecting outcome data.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>6 months</time_frame>
      <description>Proportion of eligible patients presenting to ED who are successfully recruited</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain relief</measure>
      <time_frame>60 minutes</time_frame>
      <description>Change in visual analogue scale from baseline to 60 minutes after medication administration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of eligible patients approached</measure>
      <time_frame>6 months</time_frame>
      <description>Proportion of all eligible patients who were approached by research assistants</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of attrition during the study period</measure>
      <time_frame>24 hours</time_frame>
      <description>Number of patients recruited to study who ended participation during study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain relief at 2 hours</measure>
      <time_frame>120 minutes</time_frame>
      <description>Change in visual analogue scale from baseline to 120 minutes after medication administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Freedom from headache</measure>
      <time_frame>60 minutes</time_frame>
      <description>Patients who report complete resolution of headache at 60 minutes from medication administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Need for rescue medication</measure>
      <time_frame>24 h</time_frame>
      <description>Additional medications administered by treating physician after 60 minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency department length of stay</measure>
      <time_frame>24 hours</time_frame>
      <description>Time from initial physician assessment to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to emergency department</measure>
      <time_frame>24 hours</time_frame>
      <description>Patients who were registered again to the ED within 24 hours of discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse reactions</measure>
      <time_frame>24 hours</time_frame>
      <description>Any adverse reaction reported during the study period</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Acute Migraine Headache</condition>
    <arm_group>
      <arm_group_label>Oral medications</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml NS administered over 15 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IV medications</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>2 x placebo tablets, 10 mg metoclopramide in 50 cc NS and 10 mg ketorolac in 50 ml NS administered over 15 min.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral metoclopramide and ibuprofen</intervention_name>
      <description>10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml normal saline IV administered over 15 minutes.</description>
      <arm_group_label>Oral medications</arm_group_label>
      <other_name>Maxeran, Reglan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intravenous metoclopramide and ketorolac</intervention_name>
      <description>10 mg of metoclopramide IV in 50 ml normal saline, 10 mg ketorolac IV in 50 ml normal saline administered over 15 minutes, with 2 placebo tablets.</description>
      <arm_group_label>IV medications</arm_group_label>
      <other_name>Maxeran, Reglan, Toradol</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Presentation to emergency department with headache&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vomiting or unable to tolerate PO at tie of med admin&#xD;
  &#xD;
            -  Focal neurologic symptoms&#xD;
  &#xD;
            -  Head trauma within 14d&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Concurrent use of blood thinners&#xD;
  &#xD;
            -  Hypersensitivity reaction to any of the study medications&#xD;
  &#xD;
            -  &gt;14 HA days per month&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert Ohle, MBBCh</last_name>
      <role>Principal Investigator</role>
      <affiliation>Health Sciences North Research Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Robert Ohle, MBBCh</last_name>
      <phone>(705) 523-7100</phone>
      <phone_ext>7095</phone_ext>
      <email>robert.ohle@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Caitlin Dmitriew, MD</last_name>
      <email>cdmitriew@nosm.ca</email>
    </overall_contact_backup>
    <reference>
      <citation>Azzopardi TD, Brooks NA. Oral metoclopramide as an adjunct to analgesics for the outpatient treatment of acute migraine. Ann Pharmacother. 2008 Mar;42(3):397-402. doi: 10.1345/aph.1K481. Epub 2008 Feb 19.</citation>
      <PMID>18285561</PMID>
    </reference>
    <reference>
      <citation>Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.</citation>
      <PMID>11733293</PMID>
    </reference>
    <reference>
      <citation>Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Erratum In: Headache. 2015 Feb;55(2):356.</citation>
      <PMID>25600719</PMID>
    </reference>
    <reference>
      <citation>Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. 2021 Jan;61(1):60-68. doi: 10.1111/head.14024. Epub 2020 Dec 21.</citation>
      <PMID>33349955</PMID>
    </reference>
    <reference>
      <citation>Friedman BW, Mulvey L, Esses D, Solorzano C, Paternoster J, Lipton RB, Gallagher EJ. Metoclopramide for acute migraine: a dose-finding randomized clinical trial. Ann Emerg Med. 2011 May;57(5):475-82.e1. doi: 10.1016/j.annemergmed.2010.11.023. Epub 2011 Jan 12.</citation>
      <PMID>21227540</PMID>
    </reference>
    <reference>
      <citation>Motov S, Yasavolian M, Likourezos A, Pushkar I, Hossain R, Drapkin J, Cohen V, Filk N, Smith A, Huang F, Rockoff B, Homel P, Fromm C. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2017 Aug;70(2):177-184. doi: 10.1016/j.annemergmed.2016.10.014. Epub 2016 Dec 16.</citation>
      <PMID>27993418</PMID>
    </reference>
    <reference>
      <citation>Yeh WZ, Blizzard L, Taylor BV. What is the actual prevalence of migraine? Brain Behav. 2018 Jun;8(6):e00950. doi: 10.1002/brb3.950. Epub 2018 May 2.</citation>
      <PMID>30106228</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>emergency department</keyword>
    <keyword>migraine</keyword>
    <keyword>metoclopramide</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>Ibuprofen</mesh_term>
      <mesh_term>Ketorolac</mesh_term>
      <mesh_term>Metoclopramide</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/NCT05983354
  org study id: 23-016
  nct id: NCT05983354
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot randomized control trial is to assess the feasibility of our patient
        recruitment and data collection strategy ahead of a full scale RCT investigating the efficacy
        of oral v. parenteral medications in the management of acute migraine headaches in the
        emergency department. Patients will be randomly assigned to receive either (A) standard
        medical therapy for the treatment of acute migraine headache (metoclopramide and ketorolac
        IV) and oral placebo or (B) oral metoclopramide and ibuprofen with normal saline IV. Primary
        outcome measures are recruitment rate and improvement in pain score at 60 minutes from
        medication administration.
  Objectives
  
        The planned study is a pilot study designed to assess the feasibility of our recruitment and
        data collection strategy. The primary feasibility outcome will be recruitment rate, which is
        defined as the proportion of eligible patients approached who are successfully recruited over
        the proposed 6-month pilot study period. Our secondary feasibility outcomes are (a)
        proportion of eligible patients approached and (b) rate of attrition during the study period.
  
        Our preliminary primary outcome will be improvement in pain from baseline to 60 minutes after
        medication administration using the visual analogue scale (Bijur et al. 2008). Preliminary
        secondary outcomes will include headache relief and freedom from headache at 2 h, the need
        for rescue medication, ED length of stay and return to ED within 24h of discharge. We will
        also assess frequency of adverse effects commonly associated with study medications,
        including gastrointestinal upset, patient-reported restlessness or dystonic reaction, and
        fatigue.
  
        Design
  
        In this parallel, noninferiority, double-blind randomised control pilot study, eligible
        patients presenting to the emergency department with a chief complaint of headache will be
        randomly assigned with an allocation ratio of 1:1 to receive one of 2 treatments: intravenous
        ketorolac (10 mg) and metoclopramide (10 mg) v. oral ibuprofen (400 mg) and metoclopramide
        (10 mg). Dosing was selected to reflect the lowest effective doses recommended for emergency
        department management of migraine headaches (Friedman et al. 2011, Motov et al. 2017). The
        study will last 6 months at which time it will stop.
  
        Study population
  
        Patients between the ages of 18 and 64 presenting to the ED with a chief complaint of
        headache will be eligible to participate in the study. Exclusion criteria include vomiting or
        inability to tolerate oral medications at the time of medication administration, focal
        neurologic symptoms, head trauma within 14 days, history of renal disease, contraindication
        to NSAIDs including pregnancy or concurrent use of blood thinners, hypersensitivity reaction
        to any of the study medications, or >15 headache days per month.
  
        Study procedures
  
        Treatment will be assigned using a random number generator. Contents of treatment, which will
        be identical in appearance, will be known only to the research pharmacist and this
        information will be stored remotely from the ED. Administering nurses and treating physicians
        will be blind to the treatment group, as will patients and research assistants collecting
        outcome data.
  
        Data collection
  
        Data will be collected using patient interviews immediately prior to medication
        administration and repeated at 1 and 2 hours after medication administration. A chart review
        will then be conducted to check for return visits within 24 h of ED discharge.
  
        Enrolment:
  
        Based on sample size calculations, we plan to enrol 55 patients.
  
        Statistical procedures:
  
        Primary and secondary feasibility outcomes will be reported as the proportion of patients
        approached who were recruited, proportion of eligible patients approached and the proportion
        who withdrew consent during the study period +/- 95% CI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Treatment will be randomly assigned using a random number generator by an independent research assistant who is not involved in data collection. Contents of treatment will be known only to the research pharmacist and this information will be stored remotely from the ED; patients, administering nurses and treating physicians will be blind to the treatment group, as well the research assistants collecting outcome data.
  measure: Recruitment rate
  time frame: 6 months
  description: Proportion of eligible patients presenting to ED who are successfully recruited
  measure: Pain relief
  time frame: 60 minutes
  description: Change in visual analogue scale from baseline to 60 minutes after medication administration
  measure: Proportion of eligible patients approached
  time frame: 6 months
  description: Proportion of all eligible patients who were approached by research assistants
  measure: Rate of attrition during the study period
  time frame: 24 hours
  description: Number of patients recruited to study who ended participation during study period
  measure: Pain relief at 2 hours
  time frame: 120 minutes
  description: Change in visual analogue scale from baseline to 120 minutes after medication administration
  measure: Freedom from headache
  time frame: 60 minutes
  description: Patients who report complete resolution of headache at 60 minutes from medication administration
  measure: Need for rescue medication
  time frame: 24 h
  description: Additional medications administered by treating physician after 60 minutes
  measure: Emergency department length of stay
  time frame: 24 hours
  description: Time from initial physician assessment to discharge
  measure: Return to emergency department
  time frame: 24 hours
  description: Patients who were registered again to the ED within 24 hours of discharge
  measure: Adverse reactions
  time frame: 24 hours
  description: Any adverse reaction reported during the study period
  arm group label: Oral medications
  arm group type: Experimental
  description: 10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml NS administered over 15 minutes.
  arm group label: IV medications
  arm group type: Active Comparator
  description: 2 x placebo tablets, 10 mg metoclopramide in 50 cc NS and 10 mg ketorolac in 50 ml NS administered over 15 min.
  intervention type: Drug
  intervention name: Oral metoclopramide and ibuprofen
  description: 10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml normal saline IV administered over 15 minutes.
  arm group label: Oral medications
  other name: Maxeran, Reglan
  intervention type: Drug
  intervention name: Intravenous metoclopramide and ketorolac
  description: 10 mg of metoclopramide IV in 50 ml normal saline, 10 mg ketorolac IV in 50 ml normal saline administered over 15 minutes, with 2 placebo tablets.
  arm group label: IV medications
  other name: Maxeran, Reglan, Toradol
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Robert Ohle, MBBCh
  role: Principal Investigator
  affiliation: Health Sciences North Research Institute
  last name: Robert Ohle, MBBCh
  phone: (705) 523-7100
  phone ext: 7095
  email: robert.ohle@gmail.com
  last name: Caitlin Dmitriew, MD
  email: cdmitriew@nosm.ca
  citation: Azzopardi TD, Brooks NA. Oral metoclopramide as an adjunct to analgesics for the outpatient treatment of acute migraine. Ann Pharmacother. 2008 Mar;42(3):397-402. doi: 10.1345/aph.1K481. Epub 2008 Feb 19.
  PMID: 18285561
  citation: Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
  PMID: 11733293
  citation: Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Erratum In: Headache. 2015 Feb;55(2):356.
  PMID: 25600719
  citation: Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. 2021 Jan;61(1):60-68. doi: 10.1111/head.14024. Epub 2020 Dec 21.
  PMID: 33349955
  citation: Friedman BW, Mulvey L, Esses D, Solorzano C, Paternoster J, Lipton RB, Gallagher EJ. Metoclopramide for acute migraine: a dose-finding randomized clinical trial. Ann Emerg Med. 2011 May;57(5):475-82.e1. doi: 10.1016/j.annemergmed.2010.11.023. Epub 2011 Jan 12.
  PMID: 21227540
  citation: Motov S, Yasavolian M, Likourezos A, Pushkar I, Hossain R, Drapkin J, Cohen V, Filk N, Smith A, Huang F, Rockoff B, Homel P, Fromm C. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2017 Aug;70(2):177-184. doi: 10.1016/j.annemergmed.2016.10.014. Epub 2016 Dec 16.
  PMID: 27993418
  citation: Yeh WZ, Blizzard L, Taylor BV. What is the actual prevalence of migraine? Brain Behav. 2018 Jun;8(6):e00950. doi: 10.1002/brb3.950. Epub 2018 May 2.
  PMID: 30106228
  responsible party type: Sponsor
  mesh term: Migraine Disorders
  mesh term: Emergencies
  mesh term: Headache
  mesh term: Ibuprofen
  mesh term: Ketorolac
  mesh term: Metoclopramide
  sharing ipd: No