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Fentanyl Buccal Tablets for Breakthrough Pain in Highly Tolerant Cancer Patients: Preliminary Data on the Proportionality Between Breakthrough Pain Dose and Background Dose
Journal of Pain and Symptom Management, 04/15/2011  Clinical Article

Mercadante S et al. – Fentanyl buccal tablet(FBT) in doses proportional to the high doses of opioids used for background analgesia was efficacious and well tolerated when administered for breakthrough cancer pain (BTcP).

Methods
  • 12 patients who were receiving opioids for background analgesia at doses equivalent to more than 500mg of oral morphine and had adequately controlled pain were prospectively recruited
  • BTcP was treated with proportional doses of FBT: patients receiving 600mg of oral morphine equivalents were administered 1000μg of FBT, patients receiving 900mg of oral morphine equivalents were administered 1500μg of FBT, and so on
  • For each episode of BTcP, trained nurses collected pain intensity (on a 0–10 numerical rating scale) and emerging problems when called for increases in pain considered to be severe in intensity by patients (T0) and 15 minutes after FBT administration (T15)
  • Patients were receiving mean doses of oral morphine equivalents of 1340mg (±585; range 720–2400)

Results
  • 79 events were treated with FBT (6.6±4.9 for each patient)
  • The median pain intensity of BTcP events was 8 (range 7–10), and the mean dose of FBT administered was 2233μg (±975; range 1200–4000)
  • In most events, a decrease in pain intensity >33% and >50% was observed (n=14 and n=48, respectively) 15 minutes after the administration of FBT
  • Data on 11 episodes were missed
  • Only six events were unsuccessfully treated
  • In all the patients, the level of adverse effects after FBT administration was mild and indistinguishable from that associated with the background opioid analgesia

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