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Eligible patients who agree to participate will migrate from oral opioids to transdermal patches and be followed for four weeks. Oral morphine will be provided as pain rescue medication. The patients will inform the adverse events and rescue medication consumption. The number of Fentanest® patches will be adjusted every visit aiming to reduce the rescue medication consumption and adverse events to a minimum. The WHO-QOL- bref (quality of life questionary) will be filled before and after the use of Fentanest®. Patients showing benefit are eligible to a 3 weeks compassionate study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl Transdermal | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Transdermal | Drug | Fentanest® 25 mcg/h. Each patch delivers 25 mcg of fentanyl per hour continuously for 72 hours. Therefore paches must be changed every 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary: formulation tolerability (assessed by adverse events incidence). Co primary: formulation analgesic efficacy (assessed by rescue medication demand). | 4 weeks folow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the correspondence between the dose of oral opioids available in Brazil and number of patches required. Establish directions for secure and effective migration from oral opioids to this formulation. Quality of life improvement (WHO-QOL-bref). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario da Universidade Federal do Maranhao | São Luís | Maranhão | 65020-070 | Brazil | ||
| Instituto Nacional de Cancer - Hospital do Cancer I |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Rio de Janeiro |
| Rio de Janeiro |
| 20230-130 |
| Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade Estadual Paulista "Julio de Mesquita Filho" - Campus de Botucatu - Unesp | Botucatu | São Paulo | 18618-970 | Brazil |
| Hospital A. C. Camargo | São Paulo | São Paulo | 01509-010 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP | São Paulo | São Paulo | 05403-000 | Brazil |