<?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>IRCT20180401039166N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-31</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Intramuscular vs Intravenous Sedation in Dental Treatment</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Sedative Effects of Intramuscular vs Intravenous of Ketamine, Midazolam and Atropine Cocktail in 2‒6-Year-Old Uncooperative Dental Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78292</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The samples will be divided into two groups of intramuscular and intravenous sedation by simple randomization method. The randomization unit will be independent individuals and the samples will be assigned into two groups using the individual randomization table, Blinding description: 1. Participants: Parents will know about participating in the study and performing treatment with intramuscular or intravenous sedation in two sessions, but they will be blinded to the type of sedation in each session.
2. Researcher and clinical caregiver: is responsible for performing dental treatment and is blinded to the sedation method (intramuscular or intravenous) used by the anesthesiologist.
3. Data Analyst: Data will be analyzed by a statistician who is unaware of the sedation method.</study_design>
      <phase>3</phase>
      <hc_freetext>Intramuscular and intravenous sedation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intramuscular injection:Drugs used in the intramuscular group include the combination of 6 mg/kg of ketamine (500 mg/10 ml, EXIR, Iran), 0.05 mg/kg of midazolam (0.5 mg/ml, EXIR, Iran) and 0.02 mg/kg of atropine ( 0.5 mg/ml, Daroupakhsh, Iran). Intervention 2: Intervention group: Intravenous injection: In the intravenous group, it will include 2 mg/kg of ketamine(500 mg/10 ml, EXIR, Iran), 0.0.2 mg/kg of midazolam(0.5 mg/ml, EXIR, Iran) and 0.02 mg/kg of atropine( 0.5 mg/ml, Daroupakhsh, Iran).</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 In order to protect the privacy and medical information of patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blv., Velenjak St., Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2217 5351</telephone>
        <email>leila.eftekhar.a@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blv., Velenjak St., Chamran Highway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983969411</zip>
        <telephone>+98 21 2217 5351</telephone>
        <email>leila.eftekhar.a@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Uncooperative 2–6-year-old children with definitely negative or negative Frankl scores, who were referred to the Pediatric Dentistry Fellowship Clinic at the Dental School of Shahid Beheshti University of Medical Sciences, Tehran, Iran, and required at least 2 similar dental treatment visits.The subjects were included if they were classified as ASA I, according to the American Society of Anesthesiology (ASA).</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>6 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children with nasal obstruction, respiratory infections, limitations in neck movement, macroglossia, tonsil hypertrophy, micrognathia, or limitations in mouth opening were excluded.</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>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intramuscular injection:Drugs used in the intramuscular group include the combination of 6 mg/kg of ketamine (500 mg/10 ml, EXIR, Iran), 0.05 mg/kg of midazolam (0.5 mg/ml, EXIR, Iran) and 0.02 mg/kg of atropine ( 0.5 mg/ml, Daroupakhsh, Iran)</i_keyword>
      <i_keyword>Intervention group: Intravenous injection: In the intravenous group, it will include 2 mg/kg of ketamine(500 mg/10 ml, EXIR, Iran), 0.0.2 mg/kg of midazolam(0.5 mg/ml, EXIR, Iran) and 0.02 mg/kg of atropine( 0.5 mg/ml, Daroupakhsh, Iran).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The level of sedation and behavioral evaluation based on the Houpt criterion. Timepoint: T0: the beginning of work; T1: after anesthesia injection; T2: 15 minutes after starting work, T3: 30 minutes after starting work and T4: end of work. Method of measurement: Houpt Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Physiological parameters. Timepoint: T0: the beginning of work; T1: after anesthesia injection; T2: 15 minutes after starting work, T3: 30 minutes after starting work and T4: end of work. Method of measurement: Data table.</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 Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-09</approval_date>
        <contact_name>Research School of Dental Sciences - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blv., Velenjak St., Chamran Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
