Opioid is recommended for moderate cancer pain in WHO 3-step analgesic ladder. Transdermal administration of the strong opioid fentanyl was originally developed for patients unable to swallow analgesics because of malignancies in the head and neck region or the gastrointestinal tract, painful lesions in the mouth, or periods of nausea, vomiting, or bowel obstruction. The EMA recognizes that in exceptional clinical circumstances, the 12 μg/h fentanyl patch could be considered. To our knowledge, there is not a phase III trial to explore the efficacy and safety of 12 μg/h fentanyl patch in opioid-naive patients with moderate cancer pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
209
2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days
5mg immediate-released morphine every 4 hours, double dose before sleep.
the number of responder patients
the number of responder patients is defined as patientswith a 20% reduction in pain intensity on the numerical rating scale.
Time frame: 12 months
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