<?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>IRCT201609222639N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-01</date_registration>
      <primary_sponsor>Shahid Sadoughi University of Medical Sciences, Yazd, Iran</primary_sponsor>
      <public_title>Clinical trial of efficacy evaluation of midazolam alone and midazolam with maternal presence on reduction of pain and anxiety of lumbar puncture of 6-24 month old children</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy of midazolam alone and midazolam with maternal presence in lumbar puncture of 6-24 month old children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2451</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Other disorders of central nervous system.</hc_freetext>
      <i_freetext>Intervention 1: 0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and mother will be out of the room during lumbar puncture of her child. Intervention 2: 0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and during lumbar puncture of the child, mother will be in the room and sit face to face of her child and catch child hand in her hand and dandle it while the mother and she is face to face of the person performing the lumbar puncture.</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. Farzad Ferdosian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Sadoughi Hospital, Ebnsina Blvd, Shahid Ghandi Blvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>ferdosianfarzad@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences, Yazd, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farzad Ferdosian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>hahid Sadoughi Hospital, Ebnsina Blvd, Shahid Ghandi Blvd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 35 3822 4000</telephone>
        <email>ferdosianfarzad@yahoo.com</email>
        <affiliation>Shahid Sadoughi University of Medical Sciences, Yazd, Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age range of 6-24 months; undergone lumbar puncture based on clinical judgment of the pediatrician; not received sedative hypnotic drugs within the past 48 hours&#13;
Exclusion criteria: Neurodevelopmental delay or mental retardation; loss of consciousness (Glasgow coma scale less than 12); symptoms of increased intracranial pressure; done lumbar puncture more than two times; previously undergone lumbar puncture</inclusion_criteria>
      <agemin>6 months</agemin>
      <agemax>2 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G90-G99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of central nervous system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and mother will be out of the room during lumbar puncture of her child</i_keyword>
      <i_keyword>0.5 mg/kg midazolam ampule of 5 mg/milliliter from Aburaihan Co. Tehran, Iran will be injected five minutes before lumbar puncture and during lumbar puncture of the child, mother will be in the room and sit face to face of her child and catch child hand in her hand and dandle it while the mother and she is face to face of the person performing the lumbar puncture</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score before skin needle insertion for lumbar puncture. Timepoint: Before skin needle insertion for lumbar puncture. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Pain score during needle insertion to skin. Timepoint: During needle insertion to skin for lumbar puncture. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Success rate in reducing of anxiety during skin needle insertion (anxiety score of four and more three). Timepoint: During needle insertion to skin for lumbar puncture. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Success rate in reducing of pain (pain score of less than three). Timepoint: During needle insertion to skin for lumbar puncture. Method of measurement: Questionnaire.</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>Shahid Sadoughi University of Medical Sciences, Yazd, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-03-17</approval_date>
        <contact_name>Ethics Committee of Yazd Medical Sciences University,Yazd, Iran</contact_name>
        <contact_address>Central building of university, Bahonar square Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
