Clinical trial · Interventional
Nalbuphine Versus Morphine for Mucositis Pain in Pediatric Cancer Patients
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
NCT03825887CI-TRIAL-00053008PCAcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia (PCA) for mucositis pain in pediatric cancer patients
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Stem Cell Leukemia | Acute Undifferentiated Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Morphine | Drug | — | UNRESOLVED |
| Nalbuphine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A-PCA Morphine
- description
- 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.
- interventionNames
- Drug: Morphine
- type
- EXPERIMENTAL
- label
- Group B-PCA Nalbuphine
- description
- 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.
- interventionNames
- Drug: Nalbuphine
Primary outcomes (2)
- measure
- measure the change in Pain intensity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.