<?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>IRCT2014010616106N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-02-05</date_registration>
      <primary_sponsor>Iran Center for Dental Research, Shahid Beheshti Medical University</primary_sponsor>
      <public_title>Oral Sedation  in children</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the sedative effect of oral Midazolam/Hydroxyzine vs Chloral hydrate/Hydroxizine in behavior control of 6-10 year old uncooperative children.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15164</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Each patient was seen in two separate visits in order to allow a comparison on the same patient preventing any influential factor to interfere with the outcome.</study_design>
      <phase>4</phase>
      <hc_freetext>Condition 1: Behavior Control at the Dental Clinics. Condition 2: Uncooperative behavior in dental clinic.</hc_freetext>
      <i_freetext>Intervention 1: Chloral Hydrate (50 mg/kg) /Hydroxyzine (1 mg/kg) both suspension form were given to children of the case group (oral mode), 1/2 hour before treatment start along with full monitoring the vital signs every 15 minutes starting from thew drug administration time to the discharge stage. Intervention 2: Oral suspension of Midazolam(0.5 mg/kg) along side  Hydroxyzine elexir (1mg/kg)was administered in Control session 30 minutes prior to the starting point of the dental treatment in one dose. All vital signs were monitored thoroughly and details were recorded for further analysis.</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>Ghassem Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Students Blvd, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19863</zip>
        <telephone>+98 21 2225 5958</telephone>
        <email>drgansari@yahoo.com</email>
        <affiliation>Shahid Beheshti Medical University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ghassem Ansari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dental School, Students Blvd, Evin</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19863</zip>
        <telephone>+98 21 2225 5958</telephone>
        <email>drgansari@yahoo.com</email>
        <affiliation>Shahid Beheshti Medical University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: cases with a behavioral score of 2 in Frankel scale system (Uncooperative); those with at least two similar dental needs; ages of 6-10 years old; able to attend two visits scheduled for dental treatments; able to keep 4 hours NPO prior to sedation.&#13;
Exclusion criteria: clear from any medical condition (out of the ASA I &amp; II); taking any sedative, narcotic or CNS depressant drug; those who have cold or other respiratory obstruction; those having fever of known or unknown origin; unable to observe 4 hours of NPO; unable to accept the drugs administered due to taste or volume.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>10 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F50-F59</hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Behavioural syndromes associated with physiological disturbances and physical factors</hc_keyword>
      <hc_keyword></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>Chloral Hydrate (50 mg/kg) /Hydroxyzine (1 mg/kg) both suspension form were given to children of the case group (oral mode), 1/2 hour before treatment start along with full monitoring the vital signs every 15 minutes starting from thew drug administration time to the discharge stage.</i_keyword>
      <i_keyword>Oral suspension of Midazolam(0.5 mg/kg) along side  Hydroxyzine elexir (1mg/kg)was administered in Control session 30 minutes prior to the starting point of the dental treatment in one dose. All vital signs were monitored thoroughly and details were recorded for further analysis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Assessing the success rate in child management. Timepoint: Exactly after the operation ends. Method of measurement: Behavior Assessment indices.</prim_outcome>
      <prim_outcome>Child cooperation for Dental treatment delivery. Timepoint: Immidiately after the treatment end. Method of measurement: Judged by independent pediatric dentist and the operator.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Potential side effects of the drugs. Timepoint: End of1st year of  the study. Method of measurement: Questionnaire and behavioral scales.</sec_outcome>
      <sec_outcome>Assessing the success rate in each group. Timepoint: Half way assessments of the collected data. Method of measurement: Employing behavioral rating scales available.</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 Center for Dental Research, Shahid Beheshti Medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-11-16</approval_date>
        <contact_name>Shahid Beheshti Medical University, Ethic Committee</contact_name>
        <contact_address>Dental School, Students Blvd, Evin Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
