<?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>IRCT201207253579N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-12-12</date_registration>
      <primary_sponsor>Vice chancellor for research, Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of lidocaine gel and  methoxyflurane in  cystoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of lidocaine gel and  methoxyflurane in relieving pain in patients  scheduled to undergo elective cystoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-12-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3682</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>2</phase>
      <hc_freetext>Analgesic effect  of methoxyflurane and lidocaine gel during cystoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Methoxyflurane is a volatile fluorinated hydrocarbon anesthetic  agent that is&#13;
available with 3 CC ampoules to be used in a  penthrox  inhaler.  The  inhaler is primed with 3 CC methoxyflurane. The inhaler dispenses 0.2-0.4% with the dilutor  hole open and 0.5-0.7% with it closed.&#13;
The device contains an oxygen port.&#13;
We used penthrox inhaler for administration of methoxyflurane with activated charcoal scavenging chamber. We  asked the patient to close the dilutor hole with his finger and put the inhaler mouth piece in the mouth and exhale through the mouth piece or the nose.&#13;
For each patient we used maximum one vial (3cc)  without oxygen. No more than two patients are to be administered methoxyflurane per shift. Each inhaler is just for one patient. Intervention 2: Fifteen minutes before the procedure 20 cc lidocaine gel 2% is administered. Intervention 3: In each step of the study if pain score is more than 4 (utilizing VAS) we will administer 10 microgram/kg alfentanyl.</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>Hasti Hassani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ninth Boostan Ave.,  Pasdaran St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666694515</zip>
        <telephone>+98 21 2254 9029</telephone>
        <email>hasti62h@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ninth Boostan Ave.,  Pasdaran St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666694515</zip>
        <telephone>+98 21 2254 9029</telephone>
        <email>alirezjaffari@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  patients with American Society of Anesthesiologists Physical Status Classification   (ASA class)  I and II   scheduled to undergo elective cystoscopy and their age is between 20-55 years old.&#13;
 &#13;
Exclusion criteria: Allergy to lidocaine and methoxyflurane, concurrent use of analgesics in recent 24 hours, age&gt;55 years old,  addiction, renal failure,  neuropathy, liver disease, pregnancy.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>y.48.0 y.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Inhaled anesthetics   local anesthetics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Methoxyflurane is a volatile fluorinated hydrocarbon anesthetic  agent that is&#13;
available with 3 CC ampoules to be used in a  penthrox  inhaler.  The  inhaler is primed with 3 CC methoxyflurane. The inhaler dispenses 0.2-0.4% with the dilutor  hole open and 0.5-0.7% with it closed.&#13;
The device contains an oxygen port.&#13;
We used penthrox inhaler for administration of methoxyflurane with activated charcoal scavenging chamber. We  asked the patient to close the dilutor hole with his finger and put the inhaler mouth piece in the mouth and exhale through the mouth piece or the nose.&#13;
For each patient we used maximum one vial (3cc)  without oxygen. No more than two patients are to be administered methoxyflurane per shift. Each inhaler is just for one patient.</i_keyword>
      <i_keyword>Fifteen minutes before the procedure 20 cc lidocaine gel 2% is administered.</i_keyword>
      <i_keyword>In each step of the study if pain score is more than 4 (utilizing VAS) we will administer 10 microgram/kg alfentanyl.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before entrance, at the time of drug administration, just at the instrument insertion, during  bladder examination, end of procedure and 15 minutes after operation. Method of measurement: standard visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation. Method of measurement: Electrocardiography monitoring.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation. Method of measurement: Noninvasive blood pressure.</sec_outcome>
      <sec_outcome>Blood oxygen saturation. Timepoint: Before entrance, at the time of drug administration, just at the instrument insertion, during  bladder examination, end of procedure and 15 minutes after operation. Method of measurement: Pulse Oxymetry.</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, Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-03-12</approval_date>
        <contact_name>Urology ethic committee of  Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Ninth Boostan Ave.,  Pasdaran St. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
