<?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>IRCT2016072329034N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-01</date_registration>
      <primary_sponsor>Iran University of Medical Science</primary_sponsor>
      <public_title>Effects of paracetamol and fentanyl on pain control during extracorporeal shockwave lithotripsy</public_title>
      <acronym></acronym>
      <scientific_title>The comparative effects of paracetamol and fentanyl on pain control during extracorporeal shockwave lithotripsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23429</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Calculus of kidney. Condition 2: Opioids and related analgesics.</hc_freetext>
      <i_freetext>Intervention 1: group F receive 1 µg/kg intravenous fentanyl three minutes before ESWL(Extracorporeal shock wave lithotripsy ).When visual analogue pain scale is over 3, supplemental analgesia administere to the group. Intravenous fentanyl 25 micrograms should be given in this condition. Intervention 2: Group A receive 15 mg/kg intravenous paracetamol ten min before ESWL (Extracorporeal shock wave lithotripsy ).When visual analogue pain scale is over 3, supplemental analgesia administere to the group. Intravenous fentanyl 25 micrograms should be given in this condition.</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>Ashkan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of medical science</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8826 2239</telephone>
        <email>dr.abdinezhad@gmail.com</email>
        <affiliation>Abdinezhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ashkan Abdinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hemmat freeway, next to Milad tower Tehran,  Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8826 2239</telephone>
        <email>dr.abdinezhad@gmail.com</email>
        <affiliation>Iran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria : patients between 20 to 65 years of age;Patients with American Society of Anesthesiologists (ASA) physical status I or II ;patients having upper ureteric stones6-20mm.&#13;
Exclusion criteria included: a history of chronic use of analgesics or alcohol; use any analgesic drug within 3 days before the procedure; allergy study drugs; under treatment of sedative or anti-depressant drugs; signs and symptoms of urinary tract infection,;allergy to study drugs;moderate to severe hydroureteronephrosis; presence of multiple and/or bladder and/or radiolucent stones;pregnancy; sensory neurological disease.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N20</hc_code>
      <hc_code>Y45.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of kidney and ureter</hc_keyword>
      <hc_keyword>Opioids and related analgesics</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>group F receive 1 µg/kg intravenous fentanyl three minutes before ESWL(Extracorporeal shock wave lithotripsy ).When visual analogue pain scale is over 3, supplemental analgesia administere to the group. Intravenous fentanyl 25 micrograms should be given in this condition.</i_keyword>
      <i_keyword>Group A receive 15 mg/kg intravenous paracetamol ten min before ESWL (Extracorporeal shock wave lithotripsy ).When visual analogue pain scale is over 3, supplemental analgesia administere to the group. Intravenous fentanyl 25 micrograms should be given in this condition.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: every 10 min until the end of shock wave lithotripsy. Method of measurement: visual analogue scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea and Vomiting. Timepoint: after ESWL procedure. Method of measurement: Side effects ranged 1to 3: one related to no nausea, two related to nausea without vomiting and nausea with vomiting is shown with score three.</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>Iran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-16</approval_date>
        <contact_name>Iran University of Medical Science</contact_name>
        <contact_address>Iran University of Medical Science, Hemmat freeway, next to Milad tower Tehran, Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
