<?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>IRCT20180108038276N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-09-29</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of intranasal ketamine and intravenous ketorolac in reducing non-traumatic acute headache</public_title>
      <acronym></acronym>
      <scientific_title>A Comparative Study on the Effect of Intranasal Ketamine with Intravenous Ketorolac on Reduction of Non-Traumatic Acute headache</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41516</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by simple random method, after identifying eligible patients, they will be randomly assigned a three-digit proprietary code. The last digit on the right determines the patient group. If the figure is 0, 1, 2, 3, 4, it will be placed in the intervention group (Kotorlac) and if the figure is 5, 6, 7, 8, 9, it will be placed in the control group, Blinding description: Nurses and people in charge of care are not aware of the allocation of groups. The person evaluating the patients is also not aware of the allocation.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients with acute non-traumatic headaches.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1 was treated with intravenous ketorolac at a dose of 0.5 mg / kg intravenously in a single dose. Intervention 2: Intervention group 2 received intravenous ketamine at a dose of 0.5 mg / kg intravenously.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Data on demographic information and patient pain are distributed as anonymous codes

When:
Starting data access is from 2019

To whom:
Access to data will be free for anyone interested in research

Conditions:
Granting data for scientific use without fringe is allowed

Where to obtain:
Can contact with a.noyani@shmu.ac.ir email

How to obtain:
About a month from the time of the first call through the email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hamid reza beyg rezaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital,Taleghani Street, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847167</zip>
        <telephone>0098233221620</telephone>
        <email>hbaigrezaii@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hooman.rafiee sarvari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, Taleghani Street, Kermanshah</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847167</zip>
        <telephone>0098233221620</telephone>
        <email>hooman.rafiee@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with complaints of non-traumatic acute headache
patients with aged of 18 to 50 years old
Patients with a variety of headaches including tension and cluster migraine headaches</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects who have contraindications to the use of ketorolac and vitamin drugs
Patients with focal neurological disorder
Pregnant and weaning women
Patients with headache with impaired consciousness level
Patients with Comorbidity Headaches (Liver and Kidney Failure and Immune Deficiency)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G44</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other headache syndromes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1 was treated with intravenous ketorolac at a dose of 0.5 mg / kg intravenously in a single dose.</i_keyword>
      <i_keyword>Intervention group 2 received intravenous ketamine at a dose of 0.5 mg / kg intravenously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score of patients with acute non-traumatic headache with visual analogue scale. Timepoint: Pain will be measured immediately before drug administration, 30 minutes, 1 minute and 2 hours after drug administration. Method of measurement: Visual Analog Scale.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-28</approval_date>
        <contact_name>Ethic Committee of Kermanshah University of Medical Science</contact_name>
        <contact_address>Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,iran Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
