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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
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.
CCHE
Cairo, Egypt
measure the change in Pain intensity
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
Total opioid consumptions
total dosing in mg/day
Time frame: the total consumption through the entire 7 days since initiation
Number of active and total pushes of PCA buttons
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.
Patient satisfaction: linear scale
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.
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).
Time frame: during 7 days of treatment only
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