<?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>IRCT20200602047633N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-28</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Efficacy of Nebulized Ketamine with Intravenous Morphine in Patients with Multiple Trauma</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Efficacy of Nebulized Ketamine with Intravenous Morphine in Patients with Multiple Trauma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48576</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number table
Based on a random sequence of numbers from Random.org, a table will be prepared, with the first 
Hundred consecutive numbers in Group A, the next Hundred consecutive numbers in Group B. These numbers will be assigned to each patient in order of referral, Blinding description: The drug is prepared and prescribed by the triage nurse based on which group the patient is in and none of the patients and the evaluating physician will know the type of prescription drug.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients with Multiple Trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:1 mg / kg ketamine nebulizer with a maximum dose of 50 mg, which is brought to a volume of 3 cc with distilled water and poured into the nebulizer chamber, and connected with oxygen lit 5 min / min to 10 lit / min and cc 5 Slowly inject distilled water into a vein. Intervention 2: Control group:Pour 3 cc of distilled water into the nebulizer and connect with 5 liters / min to 10 lit / min with oxygen and 0.1 mg / kg morphine with a maximum dose of 10 mg diluted with distilled water with a 5 cc syringe We inject the face slowly into the peripheral vein.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Rayat Roknabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>8965113337, House of Mohammad Rayat, Roknabad, Meybod, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8965113337</zip>
        <telephone>+98 35 3237 0718</telephone>
        <email>zahra.rayat75@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Soheila Azimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>بلوار ابن سینا</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8913893111</zip>
        <telephone>+98 35 3828 2682</telephone>
        <email>soheila.azimi1987@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Trauma patients with trauma pain with a pain score greater than 4
Age over 4 years
Age less than 65 years</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>64 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with level of consciousness 13
Housing consumption in the last 4 hours
History of seizures
Unsatisfied people to participating in the project
Psychedelics and drug addiction
Maxillofacial trauma in which the patient is unable to use a nebulizer mask
Systolic blood pressure less than 90 and more than 180
Respiratory rate less than 10
pulse rate Less than 60 and more than 140
Suspected of bleeding brain lesions or cerebral edema
Pregnancy
History of allergies to any of the drugs used in the study
Frequent nausea and vomiting
Brain Tumor
Glaucoma</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>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:1 mg / kg ketamine nebulizer with a maximum dose of 50 mg, which is brought to a volume of 3 cc with distilled water and poured into the nebulizer chamber, and connected with oxygen lit 5 min / min to 10 lit / min and cc 5 Slowly inject distilled water into a vein.</i_keyword>
      <i_keyword>Control group:Pour 3 cc of distilled water into the nebulizer and connect with 5 liters / min to 10 lit / min with oxygen and 0.1 mg / kg morphine with a maximum dose of 10 mg diluted with distilled water with a 5 cc syringe We inject the face slowly into the peripheral vein.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Response to treatment by reducing the pain intensity by two points (20 mm) in terms of visual analog scale (VAS). Timepoint: Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment. Method of measurement: visual analog scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Creating analgesia which patient's intensity pain goes below than 5. Timepoint: Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment. Method of measurement: visual analog scale (VAS).</sec_outcome>
      <sec_outcome>Determining the time to start treatment response in two groups. Timepoint: Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment. Method of measurement: visual analog scale (VAS).</sec_outcome>
      <sec_outcome>Determining the frequency of patients who failed treatment in two groups. Timepoint: At the end of the study. Method of measurement: Calculate the number.</sec_outcome>
      <sec_outcome>Determine the number of times the drug is prescribed. Timepoint: At the end of the study. Method of measurement: Calculate the number.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-11</approval_date>
        <contact_name>Ethics committee of Shahid Sadoughi University of Medical Sciences</contact_name>
        <contact_address>Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Sq., Yazd, Iran Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
