<?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>IRCT20180627040258N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-11</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Procedural sedation and analgesia of reduction of shoulder dislocation.</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial to compare the effectiveness of ketamine, propofol/ketamin with propofol/fentanilel for procedure sedation and analgesia of reduction of shoulder dislocation.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>150</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32209</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A randomized, clinical trial based on random number table, Blinding description: The dislocated shoulder patients who referred to the emergency department of Besat Nahaja Hospital, are chosen as the participants of the study. In this double-blind study, the participants and all of responsible for data collection are unaware of the patients groups and the type of drug.</study_design>
      <phase>2</phase>
      <hc_freetext>Dislocation of shoulder joint.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group I: patients are revising 1-1.5 mg/kg of intravenous ketamine from 30 to 60 seconds. Intervention 2: Intervention group II: patients are revising 1-1.5 mg/kg of intravenous ketamine with 1 mg/kg propofol from 30 to 60 seconds. Intervention 3: Intervention group III: patients are revising 1 mg/kg of intravenous propofol with 50 µg fentanyl from 30 to 60 seconds.</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:
The total data to be included are the primary and secondary effects to be shared

When:
6 months after printing results

To whom:
Our data will only be available to researchers working in science center and university.

Conditions:
Our data will be available for scholars working in science center and university.

Where to obtain:
Masood Shahabian provides the analysis code to the applicants via email: elmpajooh@yahoo.com

How to obtain:
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masood Shahabian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 3321 6512</telephone>
        <email>elmpajooh@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masood Shahabian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411718541</zip>
        <telephone>+98 21 3321 6512</telephone>
        <email>elmpajooh@yahoo.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 15 and 40 years
Lake of underlying disease such as blood pressure, diabetic, cardiovascular disease, and etc
Having dislocation orthopedic removable at emergency
Normal examination of the neuromuscular system
Non allergenic to sedative drug</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiovascular instability
Having low saccharification
Having multiple trauma
Possibility of the abdomen or chest bleeding
Having head trauma
Decreased alertness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Subluxation and dislocation of shoulder joint</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 I: patients are revising 1-1.5 mg/kg of intravenous ketamine from 30 to 60 seconds.</i_keyword>
      <i_keyword>Intervention group II: patients are revising 1-1.5 mg/kg of intravenous ketamine with 1 mg/kg propofol from 30 to 60 seconds.</i_keyword>
      <i_keyword>Intervention group III: patients are revising 1 mg/kg of intravenous propofol with 50 µg fentanyl from 30 to 60 seconds.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rate of pain. Timepoint: before and per minute until the completed reduction. Method of measurement: bispectral index scale (BIS).</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-30</approval_date>
        <contact_name>Ethics Committee of Islamic Republic of Iran Army University of Medical Sciences</contact_name>
        <contact_address>Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
