Objectives: Transdermal fentanyl delivery system (TFDS) offers advantages if oral administration of opioids is difficult because of progressive disease or poor compliance, in cancer patients (pts). The current study was conducted to assess the efficacy and safety of TFDS in a pediatric cancer population.
Patients and methods: Twenty-one pts were enrolled between June 2004 and December 2005. TFDS was applied if pts had pain under non opioids treatment, according to our step-by-step "pain protocol". Starting dose of TFDS was decided considering the dose of the last non opioids drug used. All pts didn't receive other opioids therapy before TFDS. Degree of pain was assessed using visual and numeric scales.
Results: Sixteen males and 5 females were studied, median age was 8 years (range 3-14 years). They were affected by moderate to severe pain, because of progressive and/or metastatic disease. Median starting dose was 50 microg/h (range 25-100 microg/h). Highest reached dose was 200 microg/h. In 75% of pts, starting dose was adequate. In other pts, optimal dosage was found within 36 hours. Thus, pain total control was obtained in 100% of pts, with a median delay, from starting TFDS, of 24 hours (range 12-48 hours). No toxicity was observed but a moderate lethargy, within the first 12 hours, in 30% of pts.
Conclusions: TFD was found to be an effective and safe system to treat pain in pediatric cancer pts. All pts and their families showed high compliance with TFDS. It could be also taken in account for outpatient therapy.