xml: <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/NCT05986942</url>
    </required_header>
    <id_info>
      <org_study_id>000030195314317</org_study_id>
      <nct_id>NCT05986942</nct_id>
    </id_info>
    <brief_title>Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy</brief_title>
    <official_title>Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Burak Omur</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medipol University</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>
        Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The&#xD;
        purpose of this run is to use the association between this use during surgery and the&#xD;
        attrition of post-operative pain and discomfort. In the research, laboratory and monitoring&#xD;
        results will be obtained before, during and after the operation. Postoperative patient&#xD;
        complaints will be evaluated at the postoperative service visit. This study is decided on a&#xD;
        completely voluntary basis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>postoperative pain</measure>
      <time_frame>Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.</time_frame>
      <description>Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>postoperative anxiety</measure>
      <time_frame>anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.</time_frame>
      <description>Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Anxiety</condition>
    <condition>Postoperative Pain</condition>
    <condition>Bleeding</condition>
    <arm_group>
      <arm_group_label>Dex</arm_group_label>
      <description>patients using dexmedetomidine infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fen</arm_group_label>
      <description>patients using fentanyl for induction</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fentanyl</intervention_name>
      <description>In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.</description>
      <arm_group_label>Fen</arm_group_label>
      <other_name>Talinat</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexmedetomidine</intervention_name>
      <description>In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.</description>
      <arm_group_label>Dex</arm_group_label>
      <other_name>Precedex</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or&#xD;
          adenoidectomy operation will be included&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients with ASA 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or&#xD;
          adenoidectomy operation will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          developmental delay anxiety disorder Known history of allergy to alpha-2 agonistic agents&#xD;
          use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain&#xD;
          syndrome with cardiac and craniofacial anomalies&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yaşar G Gül</last_name>
      <role>Study Director</role>
      <affiliation>Medipol University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yaşar G Gül</last_name>
      <phone>+905066235151</phone>
      <email>doctorgul@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul Medipol University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Yaşar G Gül</last_name>
        <phone>+905066235151</phone>
        <email>doctorgul@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.</citation>
      <PMID>20705788</PMID>
    </results_reference>
    <results_reference>
      <citation>Lin R, Ansermino JM. Dexmedetomidine in paediatric anaesthesia. BJA Educ. 2020 Oct;20(10):348-353. doi: 10.1016/j.bjae.2020.05.004. Epub 2020 Jul 22. No abstract available.</citation>
      <PMID>33456916</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Medipol University</investigator_affiliation>
      <investigator_full_name>Burak Omur</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>Dexmedetomidine</keyword>
    <keyword>tonsillectomy</keyword>
    <keyword>adenoidectomy</keyword>
    <keyword>postoperative anxiety</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986942
  org study id: 000030195314317
  nct id: NCT05986942
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The
        purpose of this run is to use the association between this use during surgery and the
        attrition of post-operative pain and discomfort. In the research, laboratory and monitoring
        results will be obtained before, during and after the operation. Postoperative patient
        complaints will be evaluated at the postoperative service visit. This study is decided on a
        completely voluntary basis.
  observational model: Case-Control
  time perspective: Prospective
  measure: postoperative pain
  time frame: Pain was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
  description: Postoperative pain level will be measured using the FLACC pain scale (face, legs, activity, cry, consolability). 4 and above will be considered as high pain level, below 4 as low pain level.
  measure: postoperative anxiety
  time frame: anxiety was evaluated at 0, 2, 4, 6 and 8 hours postoperatively.
  description: Postoperative anxiety level will be measured using the Pediatric Anesthesia Emergence Delirium Scale (PAED). A value of 12 and above will be considered high anxiety, and values below 12 will be considered low anxiety.
  arm group label: Dex
  description: patients using dexmedetomidine infusion
  arm group label: Fen
  description: patients using fentanyl for induction
  intervention type: Drug
  intervention name: Fentanyl
  description: In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
  arm group label: Fen
  other name: Talinat
  intervention type: Drug
  intervention name: Dexmedetomidine
  description: In Group dex, dexmedetomidine infusion will be administered to the patient during the operation. Fentanyl bolus dose will be administered during anesthesia induction in group Fen.
  arm group label: Dex
  other name: Precedex
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 10 Years
  healthy volunteers: No
  last name: Yaşar G Gül
  role: Study Director
  affiliation: Medipol University
  last name: Yaşar G Gül
  phone: +905066235151
  email: doctorgul@yahoo.com
  facility: 
  contact: 
  country: Turkey
  citation: Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.
  PMID: 20705788
  citation: Lin R, Ansermino JM. Dexmedetomidine in paediatric anaesthesia. BJA Educ. 2020 Oct;20(10):348-353. doi: 10.1016/j.bjae.2020.05.004. Epub 2020 Jul 22. No abstract available.
  PMID: 33456916
  responsible party type: Sponsor-Investigator
  investigator affiliation: Medipol University
  investigator full name: Burak Omur
  investigator title: assistant professor
  mesh term: Pain, Postoperative
  mesh term: Fentanyl
  mesh term: Dexmedetomidine
  sharing ipd: No