<?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>IRCT201012205426N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-11</date_registration>
      <primary_sponsor>Vice chancellor for research, Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effects of intra venous and epidural  fentanyl on pain reliefو hemodynamic stability, airway resistance, pulmonary static compliance  and arterial blood gas in patients with abdominal and thoracic trauma in ICU.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effects of intra venous and epidural  fentanyl on  pain relief, hemodynamic stability, airway resistance, pulmonary static compliance  and arterial blood gas in patients with abdominal and thoracic trauma in ICU.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: chest trauma. Condition 2: Abdomen trauma.</hc_freetext>
      <i_freetext>Intervention 1: Insertion of epidural catheter in the level of L1-T11 for administration of fentanyl (1 mic/kg/hour) for pain relief. Intervention 2: administration of fentanyl from intravenous line (2mic/kg/hour) for pain relif.</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>Mehdi Ahmadinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ICU ward, Shahid Bahonar hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 1223 5011</telephone>
        <email>mehdia50@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Ahmadinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>ICU ward, Shahid Bahonar hospital</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 34 1223 5011</telephone>
        <email>m.ahmadinejad@kmu.ac.ir; mehdia50@ gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with 16-80 year old age who are admitted in ICU due to chest or abdominal trauma and are under mechanical ventilation&#13;
Exclusion criteria: Age under16 and above 80 yeasr old; BMI&gt;30; Instability of spine; renal or hepatic insufficiency, ischemic heart disease,hypertension, diabetes mellitus; massive transfusion; shock and acute respiratory distress syndrome</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S21.7,S22.</hc_code>
      <hc_code>S31.1,S31.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple open wounds of thoracic wall ,Fracture of sternum,Multiple fractures of ribs ,Flail chest</hc_keyword>
      <hc_keyword>Open wound of abdominal wall ,Multiple open wounds of abdomen, lower back and pelvis,Other multiple injuries of abdomen, lower back and pelvis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Insertion of epidural catheter in the level of L1-T11 for administration of fentanyl (1 mic/kg/hour) for pain relief</i_keyword>
      <i_keyword>administration of fentanyl from intravenous line (2mic/kg/hour) for pain relif</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate-. Timepoint: at 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: Heart rate with ECG monitoring-.</prim_outcome>
      <prim_outcome>ABG. Timepoint: at 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: ABG analyzer.</prim_outcome>
      <prim_outcome>Level of consciosness. Timepoint: t 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: by GCS score.</prim_outcome>
      <prim_outcome>Static compliance-. Timepoint: at 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: static compliance from patient data of ventilator.</prim_outcome>
      <prim_outcome>Airway resistance. Timepoint: at 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: airway resistance from patient data of ventilator.</prim_outcome>
      <prim_outcome>Pain score-. Timepoint: at 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: pain score with visual analog score.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: at 0-2-6-24-50-54-72 hours after admission of patents in icu. Method of measurement: By non invasive BP monitoring of ICU.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease  level of GCS. Timepoint: GCS is evaluated every 2 houre. Method of measurement: consciousness level with GCS-.</sec_outcome>
      <sec_outcome>Respiratory depression. Timepoint: respratory rate is monitored continiously in ICU. Method of measurement: respiratory rate by  icu monitoring devices.</sec_outcome>
      <sec_outcome>Hypotension. Timepoint: BP is monitored every 1 hour-. Method of measurement: blood pressure with NIBP monitoring.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: heart rate is monitored continiously in ICU. Method of measurement: Heart rate with ECG monitoring-.</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>Vice chancellor for research, Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethic committee, Kerman University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Kerman University of Medical Sciences, Jahad street Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
