Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients (PCA)
Primary Purpose
Acute Myeloid Leukemia, Stem Cell Leukemia
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nalbuphine
Morphine
Sponsored by
About this trial
This is an interventional prevention trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed Primary AML or HSCT and ALL with oral mucositis grade III OR IV presenting in the study period.
- Age above 5 year and below 18 years
- Written Informed Consent from parents/guardian
Exclusion Criteria:
- History of mental retardation
- known or suspected allergy to any narcotics
- Presence of any other co-morbidity:
- kidney (Crcl <50)
- liver (liver enzymes more than 10 folds)
- chest (SPO2 <92% on room air)
- cardiac disease (ejection fraction <40%)
- terminal patients who scheduled for palliative care
Sites / Locations
- CCHE
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A-PCA Morphine
Group B-PCA Nalbuphine
Arm 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.
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.
Outcomes
Primary Outcome Measures
measure the change in Pain intensity
change in pain intensity by visual analogue scale (scale from 0 to 100)
Total opioid consumptions
total dosing in mg/day
Secondary Outcome Measures
Number of active and total pushes of PCA buttons
Number of active and total pushes of PCA buttons
Patient satisfaction: linear scale
Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).
Assess serious adverse events
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).
Full Information
NCT ID
NCT03825887
First Posted
January 22, 2019
Last Updated
July 29, 2021
Sponsor
Children's Cancer Hospital Egypt 57357
1. Study Identification
Unique Protocol Identification Number
NCT03825887
Brief Title
Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients
Acronym
PCA
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Cancer Hospital Egypt 57357
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia (PCA) for mucositis pain in pediatric cancer patients
Detailed Description
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:
Pain intensity VAS every 12 hours and during the performing of mouth care for each patient over the first 7 days.
Total opioid consumptions for each patient every 24 hours and the total consumption of the entire 7 days since initiation.
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.
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).
Serious adverse events. (Nausea and vomiting, pruritus, respiratory depression, urinary retention, sedation, bradycardia, hypotension).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Stem Cell Leukemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A-PCA Morphine
Arm Type
Active Comparator
Arm 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 Title
Group B-PCA Nalbuphine
Arm Type
Experimental
Arm 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(s)
Nalbuphine
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention 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.
Primary Outcome Measure Information:
Title
measure the change in Pain intensity
Description
change in pain intensity by visual analogue scale (scale from 0 to 100)
Time Frame
change occur every 12 hours and during the performing of mouth care for each patient over the first 7 days
Title
Total opioid consumptions
Description
total dosing in mg/day
Time Frame
the total consumption through the entire 7 days since initiation
Secondary Outcome Measure Information:
Title
Number of active and total pushes of PCA buttons
Description
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.
Title
Patient satisfaction: linear scale
Description
Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14).
Time Frame
at the end of the 7 days.
Title
Assess serious adverse events
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).
Time Frame
during 7 days of treatment only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed Primary AML or HSCT and ALL with oral mucositis grade III OR IV presenting in the study period.
Age above 5 year and below 18 years
Written Informed Consent from parents/guardian
Exclusion Criteria:
History of mental retardation
known or suspected allergy to any narcotics
Presence of any other co-morbidity:
kidney (Crcl <50)
liver (liver enzymes more than 10 folds)
chest (SPO2 <92% on room air)
cardiac disease (ejection fraction <40%)
terminal patients who scheduled for palliative care
Facility Information:
Facility Name
CCHE
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients
We'll reach out to this number within 24 hrs