Davies, A., Sitte, T., Elsner, F., Reale, C., Espinosa, J., Brooks, D., & Fallon, M. (2011). Consistency of efficacy, patient acceptability, and nasal tolerability of fentanyl pectin nasal spray compared with immediate-release morphine sulfate in breakthrough cancer pain. Journal of Pain and Symptom Management, 41(2), 358–366.doi: 10.1016/j.jpainsymman.2010.11.004
To compare the efficacy, tolerability, and patient acceptability of fentanyl-pectin nasal spray (FPNS) with that of immediate-release morphine sulfate (IRMS)
This study consisted of four phases: a screening phase (maximum 10 days), an open dose-titration phase (maximum 14 days), a treatment phase (minimum three days, maximum 21 days), and an end-of-treatment phase (1–14 days after the last dose). The open dose-titration phase was used to identify the FPNS dose, 100–800 mcg/episode of breakthrough pain, that was effective. Patients who achieved an effective dose in titration were eligible for the treatment phase. Five of a patient's breakthrough episodes were treated with FPNS and oral placebo and five episodes were treated with IRMS and placebo nasal spray. Scores rating pain relief were recorded at 5, 10, 15, 30, 45, and 60 minutes after treatment.
Randomized, double-blind/double-dummy (DB/DD) crossover study
This is a strong, well-conducted study that demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with breakthrough cancer pain.
FPNS is an effective alternative for management of episodes of cancer-related breakthrough pain. Nasal spray may be a route that is particularly helpful for patients who have to take a lot of oral medication. Nurses should be aware that most studies of nasal sprays have been of relatively short duration. Nasal sprays do not seem to have adverse effects on the nasal passages, but the potential effects of long-term use are unknown.