<?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>IRCT20260824070775N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-02</date_registration>
      <primary_sponsor>Pak Emirates Military Hospital Rawalpindi</primary_sponsor>
      <public_title>Comparison of Efficacy of Intranasal versus Intravenous Dexmedetomidine for Procedural Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Efficacy of Intranasal versus Intravenous Dexmedetomidine for Procedural Sedation in Pediatric Patients Undergoing Magnetic Resonance Imaging</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/92808</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Procedural Sedation. Procedural anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intranasal dexmedetomidine group: Dexmedetomidine at a dose of 2–3 µg/kg will be administered as nasal drops divided equally between both nostrils approximately 30–45 minutes before imaging. The child will be kept in a supine position for 1–2 minutes to optimize mucosal absorption, and the dose may be repeated up to a maximum of 200 µg if necessary. Intervention 2: Intravenous dexmedetomidine group: Venous access will be secured by phlebotomist (more than 5 years of experience) and dexmedetomidine will be administered as a loading dose of 0.5–2 µg/kg over 10 minutes, followed by a maintenance infusion of 0.5–1.5 µg/kg/hour, adjusted according to the required level of sedation.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Individual participant data will not be shared outside the primary research team due to institutional policy and patient privacy restrictions governing pediatric medical records. Aggregate results will be made fully available through publication</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassaan Ghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House 11 Street 3 New Harley Street Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>408000</zip>
        <telephone>+92 317 1669946</telephone>
        <email>hassaan.ghani.gb@gmail.com</email>
        <affiliation>Pak Emirates Military Hospital Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassaan Ghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House 11 Street 3 New Harley Street Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>408000</zip>
        <telephone>+92 317 1669946</telephone>
        <email>hassaan.ghani.gb@gmail.com</email>
        <affiliation>Pak Emirates Military Hospital Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 1 month to 12 years scheduled for elective MRI. American Society of Anesthesiologists (ASA) physical status I and II</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known allergy or previous anaphylaxis to dexmedetomidine. Contraindications to dexmedetomidine (cardiac failure, cardiac arrhythmias, long QT syndrome, baseline bradycardia or hypotension, use of beta-blockers or digoxin, uncontrolled arterial hypertension, or recent stroke/intracranial bleeding). For the intranasal group only: children with an upper respiratory tract infection or nasal blockage within the preceding two weeks, as this alters mucosal drug absorption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F13.90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sedative, hypnotic, or anxiolytic use, unspecified, uncomplicated</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>Intranasal dexmedetomidine group: Dexmedetomidine at a dose of 2–3 µg/kg will be administered as nasal drops divided equally between both nostrils approximately 30–45 minutes before imaging. The child will be kept in a supine position for 1–2 minutes to optimize mucosal absorption, and the dose may be repeated up to a maximum of 200 µg if necessary.</i_keyword>
      <i_keyword>Intravenous dexmedetomidine group: Venous access will be secured by phlebotomist (more than 5 years of experience) and dexmedetomidine will be administered as a loading dose of 0.5–2 µg/kg over 10 minutes, followed by a maintenance infusion of 0.5–1.5 µg/kg/hour, adjusted according to the required level of sedation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Onset of Sedation. Timepoint: Baseline (pre-sedation), every 5 minutes during the drug onset period. Method of measurement: The University of Michigan Sedation Scale (UMSS).</prim_outcome>
      <prim_outcome>Duration of Sedation. Timepoint: every 5 minutes after the drug onset period till completion of the MRI scan. Method of measurement: The University of Michigan Sedation Scale (UMSS).</prim_outcome>
      <prim_outcome>Recovery Time. Timepoint: every 5 minutes in the post-sedation recovery unit until the patient returns to baseline status (UMSS score 0). Method of measurement: The University of Michigan Sedation Scale (UMSS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Incidence of Treatment-Related Adverse Events like Bradycardia and hypotension. Timepoint: Baseline (pre-sedation), every 5 minutes during the MRI scan, and every 15 minutes in the recovery unit until discharge. Method of measurement: Tracking the frequency of specific clinical events, including bradycardia (heart rate lower than age-adjusted normal limits), hypotension (blood pressure lower than age-adjusted normal limits).</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>Pak Emirates Military Hospital Rawalpindi</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-07</approval_date>
        <contact_name>Ethical Committee Pak Emirates Military Hospital Rawalpindi</contact_name>
        <contact_address>Mall Road Rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
