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Evaluation of safety and efficacy of Nalbuphine versus Morphine patient controlled analgesia (PCA) for mucositis pain in pediatric cancer patients
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Patient satisfaction: linear scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCHE | Cairo | Egypt |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D015456 | Leukemia, Biphenotypic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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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.
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double blinded
|
| 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. |
|
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. |
| 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009022 | Morphine Derivatives |