<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/NCT03010540</url>
  </required_header>
  <id_info>
    <org_study_id>Emergence delirium</org_study_id>
    <nct_id>NCT03010540</nct_id>
  </id_info>
  <brief_title>Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair</brief_title>
  <official_title>Emergence Delirium and Recovery Profile in Patients Undergoing Cleft Lip and Palate Repair: Comparison of Combination of Morphine and Fentanyl With Fentanyl Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Medical Education and Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate&#xD;
      Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergence Delirium ( PAED Scale)</measure>
    <time_frame>30 Minutes Postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Operative Pain (FLACC Scale )</measure>
    <time_frame>30 Minutes Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Saturation Of Oxygen (SpO2 in %)</measure>
    <time_frame>30 Minutes Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Temperature (degree Celsius)</measure>
    <time_frame>30 Minutes Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate (Beats Per Minute)</measure>
    <time_frame>30 Minutes Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate (Per Minute)</measure>
    <time_frame>30 Minutes Postoperatively</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Anesthesia Emergence Delirium</condition>
  <arm_group>
    <arm_group_label>Morphine Plus Fentanyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MORPHINE PLUS FENTANYL</intervention_name>
    <description>Effect Of Morphine Plus Fentanyl On Emergence Delirium</description>
    <arm_group_label>Morphine Plus Fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Effect Of Fentanyl Only On Emergence Delirium</description>
    <arm_group_label>Fentanyl only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1 Patients Undergoing Cleft Lip And Palate Repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CNS Disorders&#xD;
&#xD;
          -  Respiratory Infection&#xD;
&#xD;
          -  GERD&#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>PGIMER</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Medical Education and Research</investigator_affiliation>
    <investigator_full_name>DR PARUL GUPTA</investigator_full_name>
    <investigator_title>Junior Resident, department of Anaesthesia and Intensive Care</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Lip</mesh_term>
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Emergence Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03010540
org study id: Emergence delirium
nct id: NCT03010540
lead sponsor: 
has dmc: No
Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate
      Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Emergence Delirium ( PAED Scale)
time frame: 30 Minutes Postoperatively
measure: Post Operative Pain (FLACC Scale )
time frame: 30 Minutes Postoperatively
measure: Saturation Of Oxygen (SpO2 in %)
time frame: 30 Minutes Postoperatively
measure: Temperature (degree Celsius)
time frame: 30 Minutes Postoperatively
measure: Heart Rate (Beats Per Minute)
time frame: 30 Minutes Postoperatively
measure: Respiratory Rate (Per Minute)
time frame: 30 Minutes Postoperatively
arm group label: Morphine Plus Fentanyl
arm group type: Experimental
arm group label: Fentanyl only
arm group type: Active Comparator
intervention type: Drug
intervention name: MORPHINE PLUS FENTANYL
description: Effect Of Morphine Plus Fentanyl On Emergence Delirium
arm group label: Morphine Plus Fentanyl
intervention type: Drug
intervention name: Fentanyl
description: Effect Of Fentanyl Only On Emergence Delirium
arm group label: Fentanyl only
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Medical Education and Research
investigator full name: DR PARUL GUPTA
investigator title: Junior Resident, department of Anaesthesia and Intensive Care
mesh term: Cleft Lip
mesh term: Delirium
mesh term: Emergence Delirium
mesh term: Fentanyl
mesh term: Morphine
sharing ipd: No