<?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>IRCT2016050615941N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-11</date_registration>
      <primary_sponsor>Shahrad Tajaddini (investigator)</primary_sponsor>
      <public_title>Fentofol vs. Ketofol for painful procedures in the emergency department</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Fentofol with Ketofol to achieve the Aldret score of 12 in painful procedures in the emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>192</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15052</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Painful procedures in the emergency department.</hc_freetext>
      <i_freetext>Intervention 1: Arm 1: Intervention name: Fentofol (Fentanyl+ Propofol)&#13;
Intervention description: Fentanyl (1 microgram/Kg by slow intravenous injection) and Propofol ( 1 milligram/Kg by slow intravenous injection) are administered in separate 5 ml syringes with a number assigned to the drugs. The patients and the investigator are blinded to the drugs in the syringe. if needed, the same doses are repeated to achieve appropriate sedation and analgesia and the total dose will subsequently be calculated.  After the end of the procedure, the Aldret score will be calculated each minute until the patient reaches a score of 12, at which point the time measurement ends. Intervention 2: Arm 2: Intervention name: Ketofol (Ketamine+ Propofol)&#13;
Intervention description: Ketamine (1milligram/Kg by slow intravenous injection) and Propofol ( 1 milligram/Kg by slow intravenous injection) are administered in separate 5 ml syringes with a number assigned to the drugs. The patients and the investigator are blinded to the drugs in the syringe. if needed, the same doses are repeated to achieve appropriate sedation and analgesia and the total dose will subsequently be calculated.  After the end of the procedure, the Aldret score will be calculated each minute until the patient reaches a score of 12, at which point the time measurement ends.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein Mirafzal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Hospital, Gharani St.,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>a.mirafzal@yahoo.com- mirafzal@kmu.ac.ir</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahrad Tajaddini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahonar Hospital, Gharani St.,</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>tajadinishahrad@gmail.com</email>
        <affiliation>Kerman University of edical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: all patients over 16 years of age for whom a painful procedure needs to be performed in the emergency department.&#13;
&#13;
Exclusion criteria: presence of any co-morbidity (ASA score more than 1); procedure needs to be done in the operating room; Spo2 less than 92%;  systolic blood pressure less than 100mmg; GCS (Glasgow coma scale) score less than 15; patient refusal to participate</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Arm 1: Intervention name: Fentofol (Fentanyl+ Propofol)&#13;
Intervention description: Fentanyl (1 microgram/Kg by slow intravenous injection) and Propofol ( 1 milligram/Kg by slow intravenous injection) are administered in separate 5 ml syringes with a number assigned to the drugs. The patients and the investigator are blinded to the drugs in the syringe. if needed, the same doses are repeated to achieve appropriate sedation and analgesia and the total dose will subsequently be calculated.  After the end of the procedure, the Aldret score will be calculated each minute until the patient reaches a score of 12, at which point the time measurement ends.</i_keyword>
      <i_keyword>Arm 2: Intervention name: Ketofol (Ketamine+ Propofol)&#13;
Intervention description: Ketamine (1milligram/Kg by slow intravenous injection) and Propofol ( 1 milligram/Kg by slow intravenous injection) are administered in separate 5 ml syringes with a number assigned to the drugs. The patients and the investigator are blinded to the drugs in the syringe. if needed, the same doses are repeated to achieve appropriate sedation and analgesia and the total dose will subsequently be calculated.  After the end of the procedure, the Aldret score will be calculated each minute until the patient reaches a score of 12, at which point the time measurement ends.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to achieve the Aldret score of 12. Timepoint: after the procedure ended. Method of measurement: counting minutes after the beginning of drug administration.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adverse reactions. Timepoint: during and after the procedure. Method of measurement: recording any adverse reactions attributable to the drugs.</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>Shahrad Tajaddini (investigator)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-10</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Faculty of medicine, Kerman University of Medical Sciences Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
