<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201405217327N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-30</date_registration>
      <primary_sponsor>Student Research Committee</primary_sponsor>
      <public_title>Comparison of the efficacy of intravenous paracetamol versus intravenous dexamethasone and intravenous morphine for the emergency department treatment of acute migraine headache</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of intravenous paracetamol versus intravenous dexamethasone and intravenous morphine for the emergency department treatment of acute migraine headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>270</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7775</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Subjects will be randomized by Random.com website.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acute migraine headache.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1 gram acetaminophen will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose.&#13;
Drug name: Apotel, 1 g/6.7ml &#13;
Chemical compound: Acetaminophen&#13;
Company: Uni Pharma S.A&#13;
country: Greece. Intervention 2: Control group: Morphine with 0.1 mg/kg dosage will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose in order to simulation.&#13;
Drug name: Morphin, 10 mg/ml Injection&#13;
Chemical compound: Morphine sulfate&#13;
company: Darou Pakhsh-Iran&#13;
Country: Iran. Intervention 3: Control group: 8 milligram dexamethasone will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose in order to simulation.&#13;
Drug name: Dexamethasone, 8 mg/ml&#13;
Chemical compound: Dexamethasone&#13;
Company: Raha Co Isfahan-Iran&#13;
Country: Iran.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Samad Shams Vahdati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine Department,Tabriz Imam Reza Hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 914 115 6941</telephone>
        <email>Shams@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Samad Shams Vahdati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine Department,Tabriz Imam Reza Hospital</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1335 2078</telephone>
        <email>shams@tbzmed.ac.ir</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : the patients between 18 and 60 year old without any history of neurologic disorder with at least one experience of migraine headache and 4 criteria of 12 criteria of Vascular symptoms. Exclusion criteria : pregnancy; history of neurologic disorder; patients without self consent; Body temperature more than 37.7 C; diastolic blood pressure more than 105 mm Hg.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1 gram acetaminophen will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose.&#13;
Drug name: Apotel, 1 g/6.7ml &#13;
Chemical compound: Acetaminophen&#13;
Company: Uni Pharma S.A&#13;
country: Greece</i_keyword>
      <i_keyword>Control group: Morphine with 0.1 mg/kg dosage will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose in order to simulation.&#13;
Drug name: Morphin, 10 mg/ml Injection&#13;
Chemical compound: Morphine sulfate&#13;
company: Darou Pakhsh-Iran&#13;
Country: Iran</i_keyword>
      <i_keyword>Control group: 8 milligram dexamethasone will be soluted in 100 cc normal saline and will be infused in 10 minutes as a single dose in order to simulation.&#13;
Drug name: Dexamethasone, 8 mg/ml&#13;
Chemical compound: Dexamethasone&#13;
Company: Raha Co Isfahan-Iran&#13;
Country: Iran</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity of the acute migrane head ache. Timepoint: Before treatment, 10 minutes after the begining of treatment, 20 minutes after the begining of the treatment, 30 minutes after the begining of the treatment, 24 hours after the begining of the treatment. Method of measurement: Visual analoge score, Intensity of the pain in proportion to millimetr from 0 to 100 will be measured.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Student Research Committee</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-02-05</approval_date>
        <contact_name>Tabriz University of Medical Scinces Ethic Committe</contact_name>
        <contact_address>Central building number 2, Tabriz University of Medical Scinces, Golgasht street, Tabriz Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
