Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia; Stem Cell Leukemia
• Interventions: Drug: Morphine; Drug: Nalbuphine

• Registration Number: NCT03825887
• Lead Sponsor: Children's Cancer Hospital Egypt 57357

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).

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-01-31
• Status Verified: 2020-07
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A-PCA Morphine	Morphine	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.
Group B-PCA Nalbuphine	Nalbuphine	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.

Primary Outcome Measures

Name	Time	Method
measure the change in Pain intensity	change occur every 12 hours and during the performing of mouth care for each patient over the first 7 days	change in pain intensity by visual analogue scale (scale from 0 to 100)
Total opioid consumptions	the total consumption through the entire 7 days since initiation	total dosing in mg/day

Secondary Outcome Measures

Name	Time	Method
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.	Number of active and total pushes of PCA buttons
Patient satisfaction: linear scale	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).
Assess serious adverse events	during 7 days of treatment only	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).

Trial Locations

Locations (1)

CCHE; 🇪🇬 Cairo, Egypt