Clinical trial NCT03825887: Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Stem Cell Leukemia
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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:

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).

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

Primary outcomes:
measure: measure the change in Pain intensity
timeFrame: change occur every 12 hours and during the performing of mouth care for each patient over the first 7 days
measure: Total opioid consumptions
timeFrame: the total consumption through the entire 7 days since initiation
Secondary outcomes:
measure: Number of active and total pushes of PCA buttons
timeFrame: every 24 hours and the sum up of the active and total pushes of PCA buttons for each patient over the 7 days.
measure: Patient satisfaction: linear scale
timeFrame: at the end of the 7 days.
measure: Assess serious adverse events
timeFrame: during 7 days of treatment only
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: CCHE
Study officials:
References: