Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients (PCA)

Children's Cancer Hospital Egypt 57357

Status and phase: Completed; Phase 3

Conditions: Stem Cell Leukemia; Acute Myeloid Leukemia

Treatments: Drug: Morphine; Drug: Nalbuphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03825887

CCHE -BM0001

Details and patient eligibility

About

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

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Group A-PCA Morphine

Active Comparator group

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.

Treatment:

Drug: Morphine

Group B-PCA Nalbuphine

Experimental group

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.

Treatment:

Drug: Nalbuphine