<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/NCT03825887</url>
  </required_header>
  <id_info>
    <org_study_id>CCHE -BM0001</org_study_id>
    <nct_id>NCT03825887</nct_id>
  </id_info>
  <brief_title>Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients</brief_title>
  <acronym>PCA</acronym>
  <official_title>Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine Patient Controlled Analgesia (PCA) for Mucositis Pain in Pediatric Patients. A Prospective Randomized Double Blinded Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Cancer Hospital Egypt 57357</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Cancer Hospital Egypt 57357</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia&#xD;
      (PCA) for mucositis pain in pediatric cancer patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will compare between using of PCA Morphine (Group A) and using of PCA&#xD;
      Nalbuphine (Group B) in the following items over the first 7 days of initiation:&#xD;
&#xD;
        1. Pain intensity VAS every 12 hours and during the performing of mouth care for each&#xD;
           patient over the first 7 days.&#xD;
&#xD;
        2. Total opioid consumptions for each patient every 24 hours and the total consumption of&#xD;
           the entire 7 days since initiation.&#xD;
&#xD;
        3. Number of active and total pushes of PCA buttons every 24 hours and the sum up of the&#xD;
           active and total pushes of PCA buttons for each patient over the 7 days.&#xD;
&#xD;
        4. Patient satisfaction at the end of the 7 days. Patient satisfaction score PSS was&#xD;
           assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).&#xD;
&#xD;
        5. Serious adverse events. (Nausea and vomiting, pruritus, respiratory depression, urinary&#xD;
           retention, sedation, bradycardia, hypotension).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>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>
    <intervention_model_description>patients with AML , ALL and bone marrow transplantation with oral mucositis grade3 or 4 were randomized into two group: patient using of PCA Morphine (Group A) patient using of PCA Nalbuphine (Group B). Patients of both groups will be started on the same dose of 10 mcg / kg / hour as a background and 10 mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40 mcg / hour.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>measure the change in Pain intensity</measure>
    <time_frame>change occur every 12 hours and during the performing of mouth care for each patient over the first 7 days</time_frame>
    <description>change in pain intensity by visual analogue scale (scale from 0 to 100)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total opioid consumptions</measure>
    <time_frame>the total consumption through the entire 7 days since initiation</time_frame>
    <description>total dosing in mg/day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of active and total pushes of PCA buttons</measure>
    <time_frame>every 24 hours and the sum up of the active and total pushes of PCA buttons for each patient over the 7 days.</time_frame>
    <description>Number of active and total pushes of PCA buttons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: linear scale</measure>
    <time_frame>at the end of the 7 days.</time_frame>
    <description>Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess serious adverse events</measure>
    <time_frame>during 7 days of treatment only</time_frame>
    <description>by reporting the number of patients with Nausea and vomiting and/or pruritus and/or respiratory depression and/or urinary retention and/or sedation and/or bradycardia and/or hypotension).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Stem Cell Leukemia</condition>
  <arm_group>
    <arm_group_label>Group A-PCA Morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10 mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40 mcg /kg/ hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B-PCA Nalbuphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10 mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40 mcg /kg/ hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nalbuphine</intervention_name>
    <description>Nalbuphine (Group B): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.&#xD;
Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.&#xD;
There is no drug shifting at any part of the study.</description>
    <arm_group_label>Group B-PCA Nalbuphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>morphine (Group A): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.&#xD;
Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.&#xD;
There is no drug shifting at any part of the study.</description>
    <arm_group_label>Group A-PCA Morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed Primary AML or HSCT and ALL with oral mucositis grade III OR IV&#xD;
             presenting in the study period.&#xD;
&#xD;
          -  Age above 5 year and below 18 years&#xD;
&#xD;
          -  Written Informed Consent from parents/guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of mental retardation&#xD;
&#xD;
          -  known or suspected allergy to any narcotics&#xD;
&#xD;
          -  Presence of any other co-morbidity:&#xD;
&#xD;
          -  kidney (Crcl &lt;50)&#xD;
&#xD;
          -  liver (liver enzymes more than 10 folds)&#xD;
&#xD;
          -  chest (SPO2 &lt;92% on room air)&#xD;
&#xD;
          -  cardiac disease (ejection fraction &lt;40%)&#xD;
&#xD;
          -  terminal patients who scheduled for palliative care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CCHE</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Mucositis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Nalbuphine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03825887
org study id: CCHE -BM0001
nct id: NCT03825887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia
      (PCA) for mucositis pain in pediatric cancer patients
The investigators will compare between using of PCA Morphine (Group A) and using of PCA
      Nalbuphine (Group B) in the following items over the first 7 days of initiation:

        1. Pain intensity VAS every 12 hours and during the performing of mouth care for each
           patient over the first 7 days.

        2. Total opioid consumptions for each patient every 24 hours and the total consumption of
           the entire 7 days since initiation.

        3. Number of active and total pushes of PCA buttons every 24 hours and the sum up of the
           active and total pushes of PCA buttons for each patient over the 7 days.

        4. Patient satisfaction at the end of the 7 days. Patient satisfaction score PSS was
           assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).

        5. Serious adverse events. (Nausea and vomiting, pruritus, respiratory depression, urinary
           retention, sedation, bradycardia, hypotension).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: patients with AML , ALL and bone marrow transplantation with oral mucositis grade3 or 4 were randomized into two group: patient using of PCA Morphine (Group A) patient using of PCA Nalbuphine (Group B). Patients of both groups will be started on the same dose of 10 mcg / kg / hour as a background and 10 mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40 mcg / hour.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blinded
measure: measure the change in Pain intensity
time frame: change occur every 12 hours and during the performing of mouth care for each patient over the first 7 days
description: change in pain intensity by visual analogue scale (scale from 0 to 100)
measure: Total opioid consumptions
time frame: the total consumption through the entire 7 days since initiation
description: total dosing in mg/day
measure: Number of active and total pushes of PCA buttons
time frame: every 24 hours and the sum up of the active and total pushes of PCA buttons for each patient over the 7 days.
description: Number of active and total pushes of PCA buttons
measure: Patient satisfaction: linear scale
time frame: at the end of the 7 days.
description: Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).
measure: Assess serious adverse events
time frame: during 7 days of treatment only
description: by reporting the number of patients with Nausea and vomiting and/or pruritus and/or respiratory depression and/or urinary retention and/or sedation and/or bradycardia and/or hypotension).
arm group label: Group A-PCA Morphine
arm group type: Active Comparator
description: Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10 mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40 mcg /kg/ hour.
arm group label: Group B-PCA Nalbuphine
arm group type: Experimental
description: Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10 mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40 mcg /kg/ hour.
intervention type: Drug
intervention name: Nalbuphine
description: Nalbuphine (Group B): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.
Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.
There is no drug shifting at any part of the study.
arm group label: Group B-PCA Nalbuphine
intervention type: Drug
intervention name: Morphine
description: morphine (Group A): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.
Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.
There is no drug shifting at any part of the study.
arm group label: Group A-PCA Morphine
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Mucositis
mesh term: Morphine
mesh term: Nalbuphine