Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients

Acute Myeloid Leukemia Clinical Trial

— PCA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825887
• Other study ID #: CCHE -BM0001
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Mucositis
• Stem Cell Leukemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	CCHE	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total opioid consumptions	total dosing in mg/day	the total consumption through the entire 7 days since initiation
Secondary	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.
Secondary	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.
Secondary	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