Sublingual administration of fentanyl to cancer patients is an effective treatment for breakthrough pain: results from a randomized phase II study

In this study we evaluated the efficacy and tolerability of sublingual fentanyl (SLF) for breakthrough pain (BTP) in adult opioid-tolerant cancer patients. Patients received one dose of placebo, SLF 100, 200 and 400 μg in random order at four pain episodes. The primary efficacy endpoint was pain int...

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Bibliographic Details
Published in:Palliative medicine 2010-04, Vol.24 (3), p.286-293
Main Authors: Lennernäs, Bo, Frank-Lissbrant, Ingela, Lennernäs, Hans, Kälkner, Karl Mikael, Derrick, Rob, Howell, Julian
Format: Article
Language:English
Subjects:
80 and over
Administration
administration & dosage
Administration, Sublingual
Adolescent
Adult
adverse effects
Aged
Aged, 80 and over
Analgesics
Analgesics, Opioid - administration & dosage
Analgesics, Opioid - adverse effects
Analgesics, Opioid - pharmacokinetics
Breakthrough pain
Cancer
Cancer and Oncology
Cancer och onkologi
chemically induced
complications
Cross-Over Studies
Dizziness
Dizziness - chemically induced
Dosage
Dose-Response Relationship
Dose-Response Relationship, Drug
Double-Blind Method
Drug
drug therapy
Efficacy
etiology
Female
Fentanyl
Fentanyl - administration & dosage
Fentanyl - adverse effects
Fentanyl - pharmacokinetics
Humans
Male
MEDICIN
MEDICINE
methods
Middle Aged
Nausea
Nausea - chemically induced
Neoplasms
Neoplasms - complications
Opioid
Pain
Pain - drug therapy
Pain - etiology
Pain Measurement
Pain Measurement - methods
pharmacokinetics
Placebos
Side effects
Sublingual
Time Factors
Treatment Outcome
Young Adult
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Summary:In this study we evaluated the efficacy and tolerability of sublingual fentanyl (SLF) for breakthrough pain (BTP) in adult opioid-tolerant cancer patients. Patients received one dose of placebo, SLF 100, 200 and 400 μg in random order at four pain episodes. The primary efficacy endpoint was pain intensity difference (PID) from baseline. Twenty-seven patients received study medication. Overall PID increased significantly with SLF 400 μg versus placebo (8.57 mm, p 20 mm) was identified by 95% of patients. Reduced use of rescue medication (p < 0.001, SLF 400 μg) and improved global assessment of treatment (p = 0.0146, SLF 400 μg) confirmed these differences as clinically important. Nausea and dizziness were the most common treatment-related adverse effects. SLF appears to be a fast, effective and well-tolerated treatment for BTP.
ISSN:0269-2163
1477-030X
1477-030X
DOI:10.1177/0269216309356138