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Randomized 5‐Treatment Crossover Study to Assess the Effects of External Heat on Serum Fentanyl Concentrations During Treatment With Transdermal Fentanyl Systems
Author(s) -
Moore Kenneth T.,
Sathyan Gayatri,
Richarz Ute,
Natarajan Jaya,
Vandenbossche Joris
Publication year - 2012
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270011411710
Subject(s) - fentanyl , transdermal , crossover study , naltrexone , anesthesia , medicine , matrix (chemical analysis) , chemistry , opioid , pharmacology , chromatography , alternative medicine , pathology , placebo , receptor
This randomized, open‐label, 5‐treatment, 5‐sequence crossover study was designed to evaluate the effects of a heating pad on serum fentanyl concentrations with reservoir and matrix transdermal fentanyl systems. Subjects were randomized to 1 of 5 treatment sequences, receiving 5 fentanyl treatments (1 per period) for 36 hours: 25 μg/h reservoir without heat, 25 μg/h reservoir with heat, 25 μg/h matrix without heat, 25 μg/h matrix with heat, and a 50 μg/h reservoir without heat. The 25 μg/h systems with heat had a heating pad applied from 0 to 10 and 26 to 36 hours post application. Washout periods between treatments were 5 to 14 days. Naltrexone was given to block the opioid effects of fentanyl. Study results indicate that external heat had a similar effect on both matrix and reservoir systems, with heat applied during the first 10 hours of treatment increasing fentanyl exposure by approximately 61% to 81% at 10 hours (observed serum concentration at 10 hours) and overall exposure (area under the curve from 0 to 10 hours) by approximately 120% to 184%, but had minimal effect from 26 to 36 hours. The increased exposure observed with heat in both 25 μg/h systems, between 0 and 10 hours, was higher than that obtained with the 50 μg/h reservoir system applied without heat.