Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

Study Overview
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Brief Summary
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Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia (PCA) for mucositis pain in pediatric cancer patients

Detailed Description
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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).

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Stem Cell Leukemia

Intervention / Treatment
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* Drug: Nalbuphine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A-PCA Morphine<br>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. | Drug: Morphine<br>* 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.<br>|
| Experimental: Group B-PCA Nalbuphine<br>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. | Drug: Nalbuphine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the change in Pain intensity | change in pain intensity by visual analogue scale (scale from 0 to 100) | 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 | the total consumption through the entire 7 days since initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of active and total pushes of PCA buttons | 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: linear scale | Patient satisfaction score PSS was assessed using a linear scale where 0=very satisfied; 10=very dissatisfied (14). | 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). | during 7 days of treatment only |