<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03799783</url>
  </required_header>
  <id_info>
    <org_study_id>4422/AO/18</org_study_id>
    <nct_id>NCT03799783</nct_id>
  </id_info>
  <brief_title>The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders</brief_title>
  <official_title>The Use of Dexmedetomidine for Procedural Sedation During EEG in Children Affected by Behavioural Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera di Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera di Padova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children's compliance during diagnostic or therapeutic procedures is a challenge, often&#xD;
      requiring the use of sedative and/or analgesic drugs.&#xD;
&#xD;
      Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time,&#xD;
      the use of any drug for sedation may affect the exam through an interference with EEG waves.&#xD;
      Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties,&#xD;
      with a long effect and which does not alter EEG pattern.&#xD;
&#xD;
      The aim of this interventional study is to evaluate the effectiveness, safety and feasibility&#xD;
      of dexmedetomidine for sedation during EEG in children who are not cooperative.&#xD;
&#xD;
      Children affected by behavioral disorders and requiring sedation to perform EEG were&#xD;
      considered. The protocol establishes to administer IV dexmedetomidine (loading dose and&#xD;
      continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale =&#xD;
      2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during&#xD;
      and after procedure until the offset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compliance during diagnostic or therapeutic procedures is a very frequent challenge in&#xD;
      children. Procedural sedation and analgesia represents an effective answer to this problem.&#xD;
      Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period.&#xD;
      Whereas the majority of children carry out this procedure without sedation, patients with&#xD;
      behavioral problems, who frequently need to rule out the presence of seizures as associated&#xD;
      symptoms or different disease, often show an insufficient compliance. Sedative drugs usually&#xD;
      interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a&#xD;
      selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a&#xD;
      long effect and which does not alter EEG pattern.&#xD;
&#xD;
      The aim of this interventional study is to evaluate effectiveness, safety and feasibility of&#xD;
      dexmedetomidine for sedation during EEG in children who are not cooperative.&#xD;
&#xD;
      Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova&#xD;
      and required sedation to perform EEG were considered in the study.&#xD;
&#xD;
      The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading&#xD;
      dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete.&#xD;
      The loading dose can be repeated up to two times, if needed, to achieve the targeted level of&#xD;
      Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during&#xD;
      procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any&#xD;
      complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before,&#xD;
      during and after procedure until the complete awake of the patient. The quality of the EEG&#xD;
      pattern was also evaluated. Occurrence and type of adverse events are registered during this&#xD;
      period. Finally, the caregivers' opinion about the quality of the sedation and the presence&#xD;
      of any sleep disturbance at home during the next 12 hours after the procedure were&#xD;
      considered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">September 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Drug administration by a loading dose followed by continuous infusion during a procedure</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)</measure>
    <time_frame>10 minutes</time_frame>
    <description>the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Adverse Events</measure>
    <time_frame>during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)</time_frame>
    <description>any adverse event potentially related with DEX-administration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Procedural Sedation</condition>
  <condition>Behavior Disorders</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <other_name>dexdor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children affected by behavior disorders who underwent EEG procedure with sedation&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA &gt; 2&#xD;
&#xD;
          -  hypersensitivity of active substance&#xD;
&#xD;
          -  therapy with beta blockers or digoxin, arrhythmia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>angela amigoni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>azienda Ospedaliera di Padova-Pediatric Intensive Care Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit - Department of Woman's and Child's Health - Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <state>PD</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG in children. Paediatr Anaesth. 2009 Dec;19(12):1175-83. doi: 10.1111/j.1460-9592.2009.03160.x.</citation>
    <PMID>20017865</PMID>
  </reference>
  <results_reference>
    <citation>Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897.</citation>
    <PMID>28557732</PMID>
  </results_reference>
  <results_reference>
    <citation>National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK82237/</citation>
    <PMID>22536619</PMID>
  </results_reference>
  <results_reference>
    <citation>Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.</citation>
    <PMID>27354454</PMID>
  </results_reference>
  <results_reference>
    <citation>Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11.</citation>
    <PMID>27516413</PMID>
  </results_reference>
  <results_reference>
    <citation>Keidan I, Ben-Menachem E, Tzadok M, Ben-Zeev B, Berkenstadt H. Electroencephalography for children with autistic spectrum disorder: a sedation protocol. Paediatr Anaesth. 2015 Feb;25(2):200-5. doi: 10.1111/pan.12510. Epub 2014 Aug 22.</citation>
    <PMID>25145661</PMID>
  </results_reference>
  <results_reference>
    <citation>Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006.</citation>
    <PMID>19589455</PMID>
  </results_reference>
  <results_reference>
    <citation>Zub D, Berkenbosch JW, Tobias JD. Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication. Paediatr Anaesth. 2005 Nov;15(11):932-8. doi: 10.1111/j.1460-9592.2005.01623.x.</citation>
    <PMID>16238552</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>November 27, 2020</results_first_submitted>
  <results_first_submitted_qc>December 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 15, 2021</results_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera di Padova</investigator_affiliation>
    <investigator_full_name>angela amigoni</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <keyword>sedation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 20, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03799783/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dexmedetomidine</title>
          <description>2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion&#xD;
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dexmedetomidine</title>
          <description>2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion&#xD;
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.3" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)</title>
        <description>the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.</description>
        <time_frame>10 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion&#xD;
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)</title>
          <description>the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Adverse Events</title>
        <description>any adverse event potentially related with DEX-administration</description>
        <time_frame>during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexmedetomidine</title>
            <description>2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion&#xD;
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Adverse Events</title>
          <description>any adverse event potentially related with DEX-administration</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 minutes</time_frame>
      <desc>Other (not including serious) adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Dexmedetomidine</title>
          <description>2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion&#xD;
dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>hypotension</sub_title>
                <description>spontaneously resolved</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>bradycardia</sub_title>
                <description>spontaneously resolved</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Angela Amigoni, MD</name_or_title>
      <organization>University Hospital Padova</organization>
      <phone>339 8333765 ext ++39</phone>
      <email>Angela.amigoni@aopd.veneto.it</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799783
org study id: 4422/AO/18
nct id: NCT03799783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Children's compliance during diagnostic or therapeutic procedures is a challenge, often
      requiring the use of sedative and/or analgesic drugs.

      Electroencephalogram (EEG) needs stillness for a medium-long period but, at the same time,
      the use of any drug for sedation may affect the exam through an interference with EEG waves.
      Dexmedetomidine is a selective ∝2-adrenergic agonist with sedative and anxiolytic properties,
      with a long effect and which does not alter EEG pattern.

      The aim of this interventional study is to evaluate the effectiveness, safety and feasibility
      of dexmedetomidine for sedation during EEG in children who are not cooperative.

      Children affected by behavioral disorders and requiring sedation to perform EEG were
      considered. The protocol establishes to administer IV dexmedetomidine (loading dose and
      continued infusion) to reach a targeted level of sedation (Pediatric Sedation State Scale =
      2). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before, during
      and after procedure until the offset.
Compliance during diagnostic or therapeutic procedures is a very frequent challenge in
      children. Procedural sedation and analgesia represents an effective answer to this problem.
      Electroencephalogram (EEG) is a procedure which needs stillness for a medium-long period.
      Whereas the majority of children carry out this procedure without sedation, patients with
      behavioral problems, who frequently need to rule out the presence of seizures as associated
      symptoms or different disease, often show an insufficient compliance. Sedative drugs usually
      interfere with EEG cerebral waves pattern, so they can not be used. Dexmedetomidine is a
      selective ∝2-adrenergic agonist with prevalent sedative and anxiolytic properties, with a
      long effect and which does not alter EEG pattern.

      The aim of this interventional study is to evaluate effectiveness, safety and feasibility of
      dexmedetomidine for sedation during EEG in children who are not cooperative.

      Children referred to the Pediatric Neurology Department of the Pediatric Hospital of Padova
      and required sedation to perform EEG were considered in the study.

      The protocol establishes to administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading
      dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete.
      The loading dose can be repeated up to two times, if needed, to achieve the targeted level of
      Pediatric Sedation State Scale (PSSS) of 2 (quiet, asleep or awake, not moving during
      procedure, and no frown or brow furrow indicating pain or anxiety, no verbalization of any
      complaint). Vital signs (SatO2, RR, EtCO2, HR, BP) and level of sedation are recorded before,
      during and after procedure until the complete awake of the patient. The quality of the EEG
      pattern was also evaluated. Occurrence and type of adverse events are registered during this
      period. Finally, the caregivers' opinion about the quality of the sedation and the presence
      of any sleep disturbance at home during the next 12 hours after the procedure were
      considered.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Drug administration by a loading dose followed by continuous infusion during a procedure
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)
time frame: 10 minutes
description: the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.
measure: Number of Patients With Adverse Events
time frame: during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)
description: any adverse event potentially related with DEX-administration
arm group label: Dexmedetomidine
arm group type: Experimental
description: 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion
intervention type: Drug
intervention name: dexmedetomidine
description: To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
arm group label: Dexmedetomidine
other name: dexdor
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
last name: angela amigoni, MD
role: Principal Investigator
affiliation: azienda Ospedaliera di Padova-Pediatric Intensive Care Unit
facility: 
country: Italy
citation: Mason KP, O'Mahony E, Zurakowski D, Libenson MH. Effects of dexmedetomidine sedation on the EEG in children. Paediatr Anaesth. 2009 Dec;19(12):1175-83. doi: 10.1111/j.1460-9592.2009.03160.x.
PMID: 20017865
citation: Cravero JP, Askins N, Sriswasdi P, Tsze DS, Zurakowski D, Sinnott S. Validation of the Pediatric Sedation State Scale. Pediatrics. 2017 May;139(5):e20162897. doi: 10.1542/peds.2016-2897.
PMID: 28557732
citation: National Clinical Guideline Centre (UK). Sedation in Children and Young People: Sedation for Diagnostic and Therapeutic Procedures in Children and Young People [Internet]. London: Royal College of Physicians (UK); 2010 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK82237/
PMID: 22536619
citation: Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
PMID: 27354454
citation: Sulton C, McCracken C, Simon HK, Hebbar K, Reynolds J, Cravero J, Mallory M, Kamat P. Pediatric Procedural Sedation Using Dexmedetomidine: A Report From the Pediatric Sedation Research Consortium. Hosp Pediatr. 2016 Sep;6(9):536-44. doi: 10.1542/hpeds.2015-0280. Epub 2016 Aug 11.
PMID: 27516413
citation: Keidan I, Ben-Menachem E, Tzadok M, Ben-Zeev B, Berkenstadt H. Electroencephalography for children with autistic spectrum disorder: a sedation protocol. Paediatr Anaesth. 2015 Feb;25(2):200-5. doi: 10.1111/pan.12510. Epub 2014 Aug 22.
PMID: 25145661
citation: Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006.
PMID: 19589455
citation: Zub D, Berkenbosch JW, Tobias JD. Preliminary experience with oral dexmedetomidine for procedural and anesthetic premedication. Paediatr Anaesth. 2005 Nov;15(11):932-8. doi: 10.1111/j.1460-9592.2005.01623.x.
PMID: 16238552
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera di Padova
investigator full name: angela amigoni
investigator title: Principal Investigator
mesh term: Mental Disorders
mesh term: Dexmedetomidine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 