<?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>IRCT20200914048715N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-20</date_registration>
      <primary_sponsor>-</primary_sponsor>
      <public_title>Comparison of the effect of ketamine and magnesium sulfate on acute asthma attack</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of ketamine nebulizer with magnesium sulfate in the treatment of patients with corticosteroid-resistant asthma referred to the emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50948</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People will be randomly divided into two groups. This study is such that patients who are candidates for inclusion in the study, after examination in terms of inclusion and exclusion criteria and obtaining informed consent using Block Randomization and software will be divided into two groups and patients in the first group treated with nebulizers. (0.3-0.1 mg / kg) and the second group will be treated with magnesium sulfate infusion (2 gr (within 20 minutes), Blinding description: This study was double-blind, so that the patient and the researcher were unaware of the status of the two groups assigned to the study. The researcher, who performs clinical and diagnostic measurements, was not aware of the status of individuals, and the statistical consultant was unaware of the allocation of individuals to study groups. Only one observer was aware of the allocation of groups.
There will be two intervention and control groups, with standard treatment for both acute asthma attacks.</study_design>
      <phase>3</phase>
      <hc_freetext>asthma.</hc_freetext>
      <i_freetext>Intervention group: and patients will be treated with nebulizerctamine (0.3-0.1 mg / kg). Before and 30 and 60 minutes after treatment with ketamine nebulizer, PEFR was measured by peak flowmeter in the minutes before and 30 minutes and 60 minutes after treatment with vital signs, Spo2 and recorded in a questionnaire sheet and comparison of two methods by soft Analysis tools will be performed. Control group: Patients who are included in the study according to the inclusion criteria will be treated with magnesium sulfate infusion (2 gr) for 20 minutes. Before, 30 and 60 minutes after magnesium sulfate treatment, PEFR With peak flowmetry in the minutes before, 30 minutes and 60 minutes after treatment with vital signs, Spo2 will be measured and recorded in the questionnaire sheet and the comparison of the two methods will be done through analysis software..</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:
All data can be published after making it unrecognizable

When:
Starting from 1/4/1400

To whom:
University researchers

Conditions:
In order to use in similar articles

Where to obtain:
1.DR Mehdi Rezaei Kojani
2.Kimia Farshadfar

How to obtain:
Apply by e-mail first. After acceptance, access is possible by sending your official document and within about a month.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mehdi rezari kojani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karaj, Hesarak, Shahid Rajaei St., Shahid Rajaei Educational and Medical Center</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197635141</zip>
        <telephone>+98 26 3457 0030</telephone>
        <email>rezaei.mehdi.md@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>mehdi rezaei kojani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Karaj, Hesarak, Shahid Rajaei St., Shahid Rajaei Educational and Medical Center</address>
        <city>karaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3197635141</zip>
        <telephone>+98 26 3457 0030</telephone>
        <email>rezaei.mehdi.md@gmail.com</email>
        <affiliation>Karaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age&lt;65
age&lt;&gt;18
Corticosteroid-resistant asthma attack
No history of allergy to ketamine or sulfamide</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction with participating in the study
age&lt;18
age&gt;65
weight&gt;40
Drug or alcohol poisoning
Active psychiatric illness
History of ketamine allergy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: and patients will be treated with nebulizerctamine (0.3-0.1 mg / kg). Before and 30 and 60 minutes after treatment with ketamine nebulizer, PEFR was measured by peak flowmeter in the minutes before and 30 minutes and 60 minutes after treatment with vital signs, Spo2 and recorded in a questionnaire sheet and comparison of two methods by soft Analysis tools will be performed. Control group: Patients who are included in the study according to the inclusion criteria will be treated with magnesium sulfate infusion (2 gr) for 20 minutes. Before, 30 and 60 minutes after magnesium sulfate treatment, PEFR With peak flowmetry in the minutes before, 30 minutes and 60 minutes after treatment with vital signs, Spo2 will be measured and recorded in the questionnaire sheet and the comparison of the two methods will be done through analysis software.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Type of treatment - Hospitalization requirement - Acute refractory asthma attack - PEFR. Timepoint: 0-30-60 MIN. Method of measurement: Ketamine protocol - number of patients admitted - peak flowmetry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-30</approval_date>
        <contact_name>ethics commitee of Alborz University of Medical Sciences</contact_name>
        <contact_address>Karaj - 45 meters from Golshahr - Saffarian Alley - Deputy of Research and Technology karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
