<?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>IRCT20160401027165N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-13</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The role of dexmedethomidine in sedation and analgesia in the emergency department</public_title>
      <acronym>ندارد</acronym>
      <scientific_title>Comparison of the combination of dexmedethomidine and fentanyl with midazolam and fentanyl in induction of sedation and analgesia for reduction of distal radial fracture in the emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-04-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28861</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: does not have, Randomization description: ُSimple Randomization, Blinding description: In this study, the researcher and clinical caregiver (professor and assistant) were not blinded due to the difference in method of each drug administration and also the need for knowledge about the type of administrating drug to deal with their possible side effects and complication, But the outcome elevator (the second senior assistant) and the data analyzer were unaware of the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>distal radial fracture.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  the first group, in this group midazolam (Darupakhsh Co, Iran) was given with dose of 0.1 mg /kg, and Fentanyl  (Abu Rayhan CO, Iran),with dose of 3 μg/kg with with titarting dose until  reaching the Ramsey sedation scale 5 . Intervention 2: Intervention group:  The second group,  in this group, dexmedethomidine (Huspiria of USA, Behestan Daroba) was given with a dose of 1 mg/kg with 10-minute intravenous infusion and fetanyl(Abu Ravihan Co, Iran) with a dose of 3 μg/kg  with titrated dose until reaching  to a Ramsey sedation scale of 5.</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>Ali Arhami Dolatabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 21 7443 2380</telephone>
        <email>aliarhami@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>ali arhami dolatabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Madani St</address>
        <city>Teran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 82174342380</telephone>
        <email>aliarhami@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients aged 18 to 60 years old who referred to the emergency department with a distal radial fracture</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient who taking antihypertensive or antihistaminic drugs
patient aged less than 18 years
Severe associated injury  include:  Head trauma and deceased level of consciousness (GCS &lt;15), Severe chest trauma        Cervical spine trauma with unstable fracture
Patients with hemodynamic instability
Patients with mental retardation
Patients with a history of heart disease  (bradycardia  and any AV heart block)
pregnant patient
history of allergy to midazolam, fentanyl and dexmedethomidine
addiction to opioids and substance abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(S60-S68)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury to the wrist and hand</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:  the first group, in this group midazolam (Darupakhsh Co, Iran) was given with dose of 0.1 mg /kg, and Fentanyl  (Abu Rayhan CO, Iran),with dose of 3 μg/kg with with titarting dose until  reaching the Ramsey sedation scale 5 .</i_keyword>
      <i_keyword>Intervention group:  The second group,  in this group, dexmedethomidine (Huspiria of USA, Behestan Daroba) was given with a dose of 1 mg/kg with 10-minute intravenous infusion and fetanyl(Abu Ravihan Co, Iran) with a dose of 3 μg/kg  with titrated dose until reaching  to a Ramsey sedation scale of 5</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before inducing sedation and analge- After the procedure and complete awakining. Method of measurement: Visual analog scale(VAS).</prim_outcome>
      <prim_outcome>Hypertension. Timepoint: Before,  during and immediately after the completion of procedure. Method of measurement: Electronic barometric( Saadat  Factory).</prim_outcome>
      <prim_outcome>Heat rate. Timepoint: Before,  during and immediately after the completion of procedure. Method of measurement: Electronic Monitor( Saadat  Factory).</prim_outcome>
      <prim_outcome>SPO2. Timepoint: Before,  during and immediately after the completion of procedure. Method of measurement: Electronic Pulsoximer( Saadat  Factory).</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before,  during and immediately after the completion of procedure. Method of measurement: Clinical examination(Obsevation).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Apnea. Timepoint: during and immediately after the completion of procedure. Method of measurement: close observation.</sec_outcome>
      <sec_outcome>Bradycardia. Timepoint: during and immediately after the completion of procedure. Method of measurement: Electronic Monitor( Saadat  Factory).</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: during and immediately after the completion of procedure. Method of measurement: close obsevation.</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>ali arhami</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-06</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Scinces</contact_name>
        <contact_address>Tabnak St, Yaman St, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
