<?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>IRCT201504251764N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-07-06</date_registration>
      <primary_sponsor>Vice chancellor for research,Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Ketamine for pediatrics pain</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy and safety of oral low dose ketamine for pediatric Intravenous  cannulation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1314</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pain during Intravenous placement in pediatrics.</hc_freetext>
      <i_freetext>Intervention 1: After obtaining consent from the parents of patients , patients are classified in two groups of intervention and control by&#13;
permuted block randomization . Then for each group a questionnaire including demographic informations , age, gender, weight, chief complaint, ASA class, primary diagnosis, receiving concomitant medications, location of Intravenous placement and other required information are recorded. In the intervention group ketamine mixed in orange juice with dose of 3 mg/kg is given to patients orally one dose. after20- 30 minutes Intravenous placement is done and the  pain of patients is measured with desired scales during the procedure. Intervention 2: After obtaining consent from the parents of patients , patients are classified in two groups of intervention and control by permuted block randomization . then for each group a questionnaire including demographic informations , age, gender, weight, chief complaint, ASA class, primary diagnosis, Receiving concomitant medications, location of Intravenous placement, duration of procedure, final diagnosis and other required information are recorded. in the control group,patients take only orange juice. after20- 30 minutes iv placement is done and the pain of patients is measured with desired scales during the procedure.</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. Mahdi Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy of Tehran University of Medical Sciences, 16 Azar Street, Enghelab Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 3605 4188</telephone>
        <email>m_mbagheri1367@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Toktam Faghihi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Pharmacy of Tehran University of Medical Sciences, 16 Azar Street, Enghelab Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 3605 4188</telephone>
        <email>tfaghihi@razi.tums.ac.irtoktamie@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: children with no pain at baseline will enter the study؛ also children take part in the study who are able to take the drug orally. &#13;
Exclusion criteria: having any medical condition in which procedure is emergent and there is no 20-30 minutes chance to take analgesic; having any contraindication for prescribing ketamine (included but not limited to high blood pressure; high intracranial pressure; high intraocular pressure; Heart failure; Thyroid diseases; Respiratory system instability); the history of taking ketamine by patient in the last 24 hour in this center (in this study); 4. American Society of Anesthesiologists class≥ III; abnormal neurological exam; lack of parental consent; having any condition that makes evaluating pain difficult; Glasgow Coma Scale less than 15.</inclusion_criteria>
      <agemin>3 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After obtaining consent from the parents of patients , patients are classified in two groups of intervention and control by&#13;
permuted block randomization . Then for each group a questionnaire including demographic informations , age, gender, weight, chief complaint, ASA class, primary diagnosis, receiving concomitant medications, location of Intravenous placement and other required information are recorded. In the intervention group ketamine mixed in orange juice with dose of 3 mg/kg is given to patients orally one dose. after20- 30 minutes Intravenous placement is done and the  pain of patients is measured with desired scales during the procedure.</i_keyword>
      <i_keyword>After obtaining consent from the parents of patients , patients are classified in two groups of intervention and control by permuted block randomization . then for each group a questionnaire including demographic informations , age, gender, weight, chief complaint, ASA class, primary diagnosis, Receiving concomitant medications, location of Intravenous placement, duration of procedure, final diagnosis and other required information are recorded. in the control group,patients take only orange juice. after20- 30 minutes iv placement is done and the pain of patients is measured with desired scales during the procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain while Intravenous placement in pediatrics. Timepoint: 30 minutes after taking oral Ketamine. Method of measurement: Measurement of pain in children ; pain score(Children's Hospital of Eastern Ontario Pain Scale, Visual Analog Scale).</prim_outcome>
      <prim_outcome>Cooperation during catheter insertion. Timepoint: 30 minutes after taking the oral ketamine. Method of measurement: I.V Sedation Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Potential side effects due to use of oral ketamine. Timepoint: first 1 hour and 24 hours after taking of oral ketamine. Method of measurement: Checklist of side effects of ketamine.</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,Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-01-26</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
