PCA: Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

• Sponsor: Children's Cancer Hospital Egypt 57357 (Other)
• Overall Status: Completed
• CT.gov ID: NCT03825887
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia; Stem Cell Leukemia	Drug: Nalbuphine; Drug: Morphine	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: double blinded
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A-PCA 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.	Drug: Morphine; 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.
Experimental: Group B-PCA 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.	Drug: Nalbuphine; 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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. Total opioid consumptions [the total consumption through the entire 7 days since initiation]

   total dosing in mg/day

Secondary Outcome Measures

1. 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

2. 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).

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCHE	Cairo		Egypt

Sponsors and Collaborators

• Children's Cancer Hospital Egypt 57357

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Cancer Hospital Egypt 57357
• ClinicalTrials.gov Identifier: NCT03825887
• Other Study ID Numbers: CCHE -BM0001
• First Posted: Jan 31, 2019
• Last Update Posted: Aug 2, 2021
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Leukemia; Mucositis; Morphine; Nalbuphine

Study Results

No Results Posted as of Aug 2, 2021