<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/NCT04445636</url>
  </required_header>
  <id_info>
    <org_study_id>N239-2020</org_study_id>
    <nct_id>NCT04445636</nct_id>
  </id_info>
  <brief_title>Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.</brief_title>
  <official_title>Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the duration of postoperative analgesia, and any side&#xD;
      effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in&#xD;
      pediatric patients undergoing thoracic surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups:&#xD;
      Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with&#xD;
      bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using&#xD;
      morphine with bupivacaine.&#xD;
&#xD;
      Randomization will be achieved by using an online random number generator. Patient codes will&#xD;
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is&#xD;
      not involved in the study. An anesthesia resident not involved in patient management will be&#xD;
      responsible for opening the envelope. The anesthesia resident will prepare the study drug&#xD;
      according to the instructions contained within each envelope and give it to the&#xD;
      anesthesiologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomization will be achieved by a statistician using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of postoperative analgesia in hours.</measure>
    <time_frame>3 months</time_frame>
    <description>Duration of postoperative analgesia in hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption in the first 24 hours post- operative.</measure>
    <time_frame>3 months</time_frame>
    <description>Opioid consumption in the first 24 hours post- operative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of ICU stay in days</measure>
    <time_frame>3 months</time_frame>
    <description>The duration of ICU stay in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score FLACC from 0 to 6</measure>
    <time_frame>3 months</time_frame>
    <description>Pain score FLACC from 0 to 6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative heart rate</measure>
    <time_frame>3 months</time_frame>
    <description>Postoperative heart rate in beat per minute</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Caudal block with Dexametomedine as an adjuvant to bupivacaine.</description>
    <arm_group_label>Dexmedetomidine group</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>Addition of morphine as adjuvant to bupivacaine during caudal block.</description>
    <arm_group_label>Morphine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I, II, III.&#xD;
&#xD;
          -  Patients undergoing lung cyst excision.&#xD;
&#xD;
          -  Patients undergoing Patent Ductus Arteriosus ligation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative mechanical ventilation.&#xD;
&#xD;
          -  Preoperative inotropic support&#xD;
&#xD;
          -  History of mental retardation or delayed development that may interfere with pain&#xD;
             intensity assessment&#xD;
&#xD;
          -  Known or suspected coagulopathy,&#xD;
&#xD;
          -  Any congenital anomalies of the sacrum or any infection at the site of injection.&#xD;
&#xD;
          -  Known or suspected allergy to any of the studied drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AHMED ISMAIL, Lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University Hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.</citation>
    <PMID>22013248</PMID>
  </reference>
  <reference>
    <citation>El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.</citation>
    <PMID>24843324</PMID>
  </reference>
  <reference>
    <citation>Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23.</citation>
    <PMID>27550555</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>December 18, 2020</last_update_submitted>
  <last_update_submitted_qc>December 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdelaziz Ismail</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>thoracic surgeries</keyword>
  <keyword>pediatric caudal</keyword>
  <keyword>dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The patients data are confidential</ipd_description>
  </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/NCT04445636
org study id: N239-2020
nct id: NCT04445636
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the duration of postoperative analgesia, and any side
      effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in
      pediatric patients undergoing thoracic surgeries.
The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups:
      Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with
      bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using
      morphine with bupivacaine.

      Randomization will be achieved by using an online random number generator. Patient codes will
      be placed into sequentially numbered sealed opaque envelopes by a research assistant who is
      not involved in the study. An anesthesia resident not involved in patient management will be
      responsible for opening the envelope. The anesthesia resident will prepare the study drug
      according to the instructions contained within each envelope and give it to the
      anesthesiologist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomization will be achieved by a statistician using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
measure: Duration of postoperative analgesia in hours.
time frame: 3 months
description: Duration of postoperative analgesia in hours.
measure: Opioid consumption in the first 24 hours post- operative.
time frame: 3 months
description: Opioid consumption in the first 24 hours post- operative.
measure: The duration of ICU stay in days
time frame: 3 months
description: The duration of ICU stay in days
measure: Pain score FLACC from 0 to 6
time frame: 3 months
description: Pain score FLACC from 0 to 6
measure: Post operative heart rate
time frame: 3 months
description: Postoperative heart rate in beat per minute
arm group label: Dexmedetomidine group
arm group type: Experimental
description: A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia.
arm group label: Morphine group
arm group type: Experimental
description: A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.
intervention type: Drug
intervention name: Dexmedetomidine
description: Caudal block with Dexametomedine as an adjuvant to bupivacaine.
arm group label: Dexmedetomidine group
other name: Precedex
intervention type: Drug
intervention name: Morphine
description: Addition of morphine as adjuvant to bupivacaine during caudal block.
arm group label: Morphine group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
last name: AHMED ISMAIL, Lecturer
role: Study Director
affiliation: Cairo University Hospitals
facility: 
country: Egypt
citation: Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
PMID: 22013248
citation: El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
PMID: 24843324
citation: Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23.
PMID: 27550555
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdelaziz Ismail
investigator title: Director
mesh term: Dexmedetomidine
mesh term: Morphine
sharing ipd: No
ipd description: The patients data are confidential