<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/NCT03307590</url>
  </required_header>
  <id_info>
    <org_study_id>Caudaldexsupraumblical</org_study_id>
    <nct_id>NCT03307590</nct_id>
  </id_info>
  <brief_title>Comparing Dexmedetomidine With Bupivacaine Versus Bupivacaine Alone for Caudal Block in Supra - Umbilical Surgeries</brief_title>
  <official_title>Adding Dexmedetomidine to Caudal Bupivacaine for Analgesia in Supra - Umbilical Pediatric Surgeries: Would it Add More Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically&#xD;
      or combined to local anesthetics during regional blocks. Investigators studied the&#xD;
      combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in&#xD;
      pediatric patients undergoing supra - umbilical surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared&#xD;
      to caudal bupivavaine alone for analgesia following upper trunk surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain relief</measure>
    <time_frame>6 months study</time_frame>
    <description>CHEOPS scale value</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>D group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dexmedetomidine with bupivacaine group Caudal dexmedetomidine 1.5 microgram/kg with bupivavaine (0.25%) 1.25 ml/kg were administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine only group Caudal bupivavaine (0.25%) 1.25 ml/kg without dexmedetomidine was administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Caudal block by dexmedetomidine and bupivavaine</description>
    <arm_group_label>D group</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Caudal block by bupivavaine alone</description>
    <arm_group_label>B group</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  supra - umbilical surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to the drug or coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Kareem</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT03307590
org study id: Caudaldexsupraumblical
nct id: NCT03307590
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
dexmedetomidine is an alpha 2 adrenergic receptor agonist that is given either systemically
      or combined to local anesthetics during regional blocks. Investigators studied the
      combination of dexmedetomedine/bupivacaine versus bupivacaine alone for caudal blockage in
      pediatric patients undergoing supra - umbilical surgeries.
Dexmedetomidine was combined to bupivavaine and administered via caudal route to be compared
      to caudal bupivavaine alone for analgesia following upper trunk surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Pain relief
time frame: 6 months study
description: CHEOPS scale value
arm group label: D group
arm group type: Active Comparator
description: Dexmedetomidine with bupivacaine group Caudal dexmedetomidine 1.5 microgram/kg with bupivavaine (0.25%) 1.25 ml/kg were administered
arm group label: B group
arm group type: Active Comparator
description: Bupivacaine only group Caudal bupivavaine (0.25%) 1.25 ml/kg without dexmedetomidine was administered
intervention type: Drug
intervention name: Dexmedetomidine
description: Caudal block by dexmedetomidine and bupivavaine
arm group label: D group
other name: Precedex
intervention type: Drug
intervention name: Bupivacaine
description: Caudal block by bupivavaine alone
arm group label: B group
other name: Marcaine
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Kareem
investigator title: Anesthesiologist
mesh term: Dexmedetomidine
mesh term: Bupivacaine
sharing ipd: Undecided