<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/NCT03252405</url>
  </required_header>
  <id_info>
    <org_study_id>emergence agitation</org_study_id>
    <nct_id>NCT03252405</nct_id>
  </id_info>
  <brief_title>Effect of Induction Method in Post Operative Agitation</brief_title>
  <official_title>the Effect of Two Different Method; Mask Ventilation or Intravenous Canulation on Emergence Agitation and Recovery Conditions on Pediatric Adenotonsillectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahi Evran University Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ahi Evran University Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the effect of two different induction method; mask ventilation and intravenous&#xD;
      cannulation on emergence agitation on pediatric adenotonsillectomy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many things cause emergence agitation after operations on pediatric population. This research&#xD;
      aims determine which method, mask ventilation or intravenous cannulatin is more effective on&#xD;
      emergence agitation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>assess changing in pediatric agitation/ emergence delirium scale(PAED) scores</measure>
    <time_frame>postoperative first hour</time_frame>
    <description>to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FLACC (face, legs,activity, cry, consolobility)</measure>
    <time_frame>postoperative first hour</time_frame>
    <description>to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Emergence Agitation</condition>
  <arm_group>
    <arm_group_label>mask ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>induction is made with mask ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intravenous induction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>induction is made with intravenous cannulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>mask ventilation</intervention_name>
    <description>before intravenous induction, mask application is made. then intravenous cannulation and induction</description>
    <arm_group_label>mask ventilation</arm_group_label>
    <other_name>induction method with mask ventilation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intravenous cannulation</intervention_name>
    <description>induction is applied by using intravenous cannulation</description>
    <arm_group_label>intravenous induction</arm_group_label>
    <arm_group_label>mask ventilation</arm_group_label>
    <other_name>induction method with intravenous cannulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric adenotonsillectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with neurological, hepatic, renal disorders and using any drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>kevser peker</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ahi Evran University Education and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dışkapı Yıldırım Beyazıt Education and research hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ahi evran university education and research hospital</name>
      <address>
        <city>Kırşehir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ahi Evran University Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Kevser Peker</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychomotor Agitation</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03252405
org study id: emergence agitation
nct id: NCT03252405
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To compare the effect of two different induction method; mask ventilation and intravenous
      cannulation on emergence agitation on pediatric adenotonsillectomy
Many things cause emergence agitation after operations on pediatric population. This research
      aims determine which method, mask ventilation or intravenous cannulatin is more effective on
      emergence agitation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: double blind
measure: assess changing in pediatric agitation/ emergence delirium scale(PAED) scores
time frame: postoperative first hour
description: to asses change of intensity of postoperative emergence agitation/ delirium (PAED) by using pediatric agitation emergence delirium scale with scores. to assess changing PAED scores at one hour after transfer into the post anesthesia care unit.
measure: FLACC (face, legs,activity, cry, consolobility)
time frame: postoperative first hour
description: to asses postoperative pain intensity with scores by FLACC (face, legs,activity, cry, consolobility) scale after transfer into the post anesthesia care unit
arm group label: mask ventilation
arm group type: Active Comparator
description: induction is made with mask ventilation
arm group label: intravenous induction
arm group type: Experimental
description: induction is made with intravenous cannulation
intervention type: Device
intervention name: mask ventilation
description: before intravenous induction, mask application is made. then intravenous cannulation and induction
arm group label: mask ventilation
other name: induction method with mask ventilation
intervention type: Device
intervention name: intravenous cannulation
description: induction is applied by using intravenous cannulation
arm group label: intravenous induction
arm group label: mask ventilation
other name: induction method with intravenous cannulation
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: kevser peker
role: Principal Investigator
affiliation: Ahi Evran University Education and Research Hospital
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ahi Evran University Education and Research Hospital
investigator full name: Kevser Peker
investigator title: MD
mesh term: Psychomotor Agitation
mesh term: Emergence Delirium
sharing ipd: Undecided