Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

NCT03825887 | Completed Phase 3

• 1 other identifier: CCHE -BM0001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukemia; Stem Cell Leukemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (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.

• Patient satisfaction: linear scale

  at the end of the 7 days.

• Assess serious adverse events

  during 7 days of treatment only

Study Arms (2)

Group A-PCA Morphine

ACTIVE COMPARATOR

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

Group B-PCA Nalbuphine

EXPERIMENTAL

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

Interventions

Nalbuphine DRUG

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.

Group B-PCA Nalbuphine

Morphine DRUG

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.

Group A-PCA Morphine

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Cancer Hospital Egypt 57357: lead

Study Sites (1)

CCHE

Cairo, Egypt

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Biphenotypic, Acute

Interventions

Nalbuphine; Morphine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 31, 2019
• Study Start: February 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 2, 2021

Record last verified: 2020-07

Locations

EG (1)