Abstract
The aim of this randomized, crossover, comparison study was to assess the analgesic
and adverse effects of 2 nasal preparations, intranasal fentanyl (INFS) and fentanyl
pectin nasal spray (FPNS), for breakthrough pain, given in doses proportional to opioid
basal regimen. Each patient randomly received INFS or FPNS in doses proportional to
opioid dosages used for background analgesia for 2 pairs of episodes. For each episode
of breakthrough pain, pain intensity and adverse effects intensity were recorded just
before starting the INFS or FPNS (T0) and 5 minutes (T5), 10 minutes (T10), and 20 minutes
(T20) after the administration of the nasal drugs. Sixty-nine patients were studied.
The mean age was 63.4 years, and 37 patients were males. For the present analysis,
188 episodes were considered. A statistical decrease in pain intensity was observed
with both nasal drugs after 5, 10, and 20 minutes. A decrease in pain intensity of
>33% was observed in 16, 102, and 159 treated episodes at T5, T10, and T20, respectively.
Adverse effects were of mild nature in most cases or were preexistent because of basal
opioid therapy. No differences were found in summed pain intensity difference 20 minutes
after dosing. Most of patients did not find substantial preferences. INFS and FPNS
were effective and well-tolerated treatments for breakthrough pain management. Both
delivery systems, in doses proportional to the basal opioid regimen, provided significant
analgesia within 10 minutes, without producing relevant adverse effects.
Perspective
This article showed that INFS and FPNS in doses proportional to basal opioid regimen
are equally safe and effective for the management of breakthrough pain in cancer patients.
These data provide new insights on the use of nasal preparations of fentanyl.
Key words
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Article info
Publication history
Published online: February 21, 2014
Accepted:
February 10,
2014
Received in revised form:
January 31,
2014
Received:
November 12,
2013
Footnotes
No funding was received for this study.
Dr. Mercadante acts as advisor for TEVA, Molteni, Grunenthal, and Janssen. This study was not supported by any industry.
None of authors' spouses, partners, or children have financial relationships that may be relevant to the submitted work; and none of the other authors have any nonfinancial interests that may be relevant to the submitted work.
Identification
Copyright
© 2014 American Pain Society. Published by Elsevier Inc. All rights reserved.
