<?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>IRCT2015112325202N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-01-31</date_registration>
      <primary_sponsor>parisa shirzad</primary_sponsor>
      <public_title>Comparison of the three types of drugs to reduce propofol pain</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparisson effect of pretreatment with ondansetron, lidocaine and paracetamol drugs on  pain reduction  due to  interavenous injectionof  Propofol</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>164</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21111</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acut pain after propofol injection.</hc_freetext>
      <i_freetext>Intervention 1: Intervention 1: Paracetamol: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro  within 20 seconds will inject from  the desired vein. Intervention 2: Intervention 2:ondancetronl: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro  within 20 seconds will inject from  the desired vein. Intervention 3: Intervention 3: lidocain: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro  within 20 seconds will inject from  the desired vein. Intervention 4: Control group: distilled water all steps will be similar to the intervention group.</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>Parisa Shirzad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hamadan Medical School</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 818138378247</telephone>
        <email>Fairyborn7@yahoo.com</email>
        <affiliation>Hamadan University Of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Zolhavarieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Beheshti hospital</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3838 0092</telephone>
        <email>dsmbszolhavarieh@gmail.com</email>
        <affiliation>Hamadan University Of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: " age 18 to 65 years" "patients with ASA class 1 and 2" " patients undergoing elective surgery"&#13;
 Exclusion criteria:" (1) patients with ASA class of 3 or higher&#13;
2. Patients with a history of HTN and DM&#13;
3. Patients with a history of narcotic or psychotropic abuse or NSAID&#13;
4. The patient who are contraindicate for propofol, ondansetron, paracetamol and lidocaine drugs</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0A</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>pain, Vomiting, nausia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention 1: Paracetamol: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro  within 20 seconds will inject from  the desired vein.</i_keyword>
      <i_keyword>Intervention 2:ondancetronl: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro  within 20 seconds will inject from  the desired vein</i_keyword>
      <i_keyword>Intervention 3: lidocain: Closing pressure cuff on the arm on the same side and blowing tourniquet pressure to 70 mm Hg, partial occlusion of the venous system has been established and this drug will be injected within 10 seconds, after 2 minutes cuff pressure discharge and a quarter of total dose Propofol 1% (2.5 mg kg) of Austria in order freseniuskabi company darman yab daro  within 20 seconds will inject from  the desired vein</i_keyword>
      <i_keyword>Control group: distilled water all steps will be similar to the intervention group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Reduce the pain of Propofol injection. Timepoint: Along with propofol infusion in 20 seconds. Method of measurement: four-point verbal rating scale = VRS) which contains no pain = 0 , mild= 1 , moderate= 2  and severe =score 3 (by tearing or rejection injected organs or patient complain of pain or frown).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Check of pain and swelling and allergic reactions of drugs within 2 hours after injection were recorded in questionnair. Timepoint: within 2 hours after injection of drugs. Method of measurement: Observation and question.</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>parisa shirzad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-23</approval_date>
        <contact_name>Ethics committee of Hamadan Univercity of Medical Science</contact_name>
        <contact_address>shahid fahmideh avenue Hamadan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
