Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients
Condition: Acute Myeloid Leukemia; Stem Cell Leukemia
MeSH terms: Leukemia; Mucositis
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Nalbuphine; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Morphine; Nalbuphine
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention