Status:
COMPLETED
Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients
Lead Sponsor:
Children's Cancer Hospital Egypt 57357
Conditions:
Acute Myeloid Leukemia
Stem Cell Leukemia
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03825887
Start Date
February 1 2018
End Date
December 31 2020
Last Update
August 2 2021
Active Locations (1)
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1
CCHE
Cairo, Egypt