<?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>IRCT201107046942N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-07-21</date_registration>
      <primary_sponsor>National Research Institute of Tuberculosis &amp; Lung Disease</primary_sponsor>
      <public_title>The effect of interpleural and intravenous morphine on pain after video-assisted thoracoscopic surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of interpleural versus intravenous morphine for pain relief after video-assisted thoracoscopic Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7398</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>4</phase>
      <hc_freetext>Two different analgesic methods after VATS.</hc_freetext>
      <i_freetext>Intervention 1: At the end of VATS, eligible patients in control group will receive  a single bolus of 0.1 mg/kg of morphine intravenously. Intervention 2: At the end of VATS, eligible patients in intervention group will receive a single bolus of 0.1 mg/kg of morphine interpleurally.</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>Dr. Tahereh Parsa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tracheal Disease Research Center, Masih Daneshvari Hospital, Darabad, Niavaran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 9644</telephone>
        <email>tparsa849@yahoo.com</email>
        <affiliation>National Research Institute of Tuberculosis &amp; Lung Disease</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Shideh Dabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1956944413</zip>
        <telephone>+98 21 2610 9644</telephone>
        <email>info@nritld.ac.ir</email>
        <affiliation>Tracheal Diseases Research Center, National Research Institute of Tuberculosis &amp; Lung Disease</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: ASA Class 1&amp; 2, Age more than or equal 18, Weight more than or equal 40 kg, no limitations in terms of sex, height, surgery duration, type of surgical procedure, number and location of chest tubes.&#13;
Exclusion criteria: Opium/alcohol addiction, drug abuse, mental retardation, psychological disorders, severe pleural adhesions and fibrosis, bronchopleural fistula, severe empyema, ASA class more than or equal 3, opioid consumption prior to surgery, inability to clamp chest tubes after surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y90, Y91, </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Supplementary factors related to causes of morbidity and mortality classified elsewhere</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>At the end of VATS, eligible patients in control group will receive  a single bolus of 0.1 mg/kg of morphine intravenously</i_keyword>
      <i_keyword>At the end of VATS, eligible patients in intervention group will receive a single bolus of 0.1 mg/kg of morphine interpleurally</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain severity after VATS. Timepoint: every one hour during the first postoperative 8 hours. Method of measurement: Visual analoge scale, supplemental analgesic consumption.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mean arterial pressure. Timepoint: every one hour during first postoperatve 8 hours. Method of measurement: NIBP.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: every one hour during first postoperatve 8 hours. Method of measurement: ECG.</sec_outcome>
      <sec_outcome>SPO2. Timepoint: every one hour during first postoperatve 8 hours. Method of measurement: pulse oxymeter.</sec_outcome>
      <sec_outcome>Side effects (nausea, vomiting,pruritus, respiratory depression). Timepoint: every one hour during first postoperatve 8 hours. Method of measurement: observation and question.</sec_outcome>
      <sec_outcome>Sedation score. Timepoint: every one hour during first postoperatve 8 hours. Method of measurement: Ramsay sedation scale.</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>National Research Institute of Tuberculosis &amp; Lung Disease</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2004-11-20</approval_date>
        <contact_name>National Research Institute of Tuberculosis &amp; Lung Disease</contact_name>
        <contact_address>Masih Daneshvari Hospital, Darabad, Niavaran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
