Intranasal Fentanyl Versus Fentanyl Pectin Nasal Spray for the Management of Breakthrough Cancer Pain in Doses Proportional to Basal Opioid Regimen

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.

Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Randomized, Crossover, Comparison Study

“…33 In a recent controlled study, two different nasal fentanyl products, given in doses proportional to the basal opioid regimen, were similarly effective and safe. 39 Limitations of this study include the lack of blinding or double-dummy technique. However, such types of studies are complex and require economic support from the pharmaceutical industry, which was not involved in this case.…”

Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group

“…SLF was also rated the best for palatability and overall impression. However, it was unclear what was the usual rescue analgesic and only three fentanyl products were evaluated in the form of placebo [43].…”

Long-term efficacy and tolerability of intranasal fentanyl in the treatment of breakthrough cancer pain

“…It has been shown 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 [46]. The treatment was effective and able to maintain sleep quality at acceptable levels, rather than being particularly accepted by patients who were particularly satisfied with the treatment.…”