Portenoy, R.K., Burton, A.W., Gabrail, N., Taylor, D., & Fentanyl Pectin Nasal Spray 043 Study Group. (2010). A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain, 151(3), 617–624.
To demonstrate the safety and efficacy of fentanyl-pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain
Consenting patients entered an open label-titration phase for determination of effective dose of FPNS. Effective dose was defined as a dose that achieved successful treatment of two breakthrough episodes. In the titration phase, if pain relief was unacceptable at 30 minutes, the patient was able to take his or her previous rescue medication. Doses were sequentially increased up to 800 mcg. Individuals who achieved an effective dose were eligible to continue in the double-blind stage. Patients received randomly assigned separate bottles, identified by number. Patients were instructed to use the bottles in the order designated. Each breakthrough episode was treated with a single dose. Pain that continued to require treatment after 30 minutes was treated with the patient’s usual rescue medication. Electronic diaries were used for data collection. Patients recorded pain intensity and pain relief at 5, 10, 15, 30, 45, and 60 minutes. Adverse events were recorded throughout the study, and visual nasal assessments were performed by the study physician at baseline and at the end of treatment. Maximum study duration was eight weeks.
Multisite (26 in the United States and 2 in other countries)
Randomized double-blind placebo-controlled crossover study
FPNC is effective and well tolerated for treatment of breakthrough cancer pain.
FPNS is an effective approach to the management of the breakthrough pain of patients with cancer who are taking opiods for relief of background pain. FPNS can be a useful alternative in situations where clinicians want to reduce the number of oral medications. Studies of the use of nasal sprays have been relatively brief, so nurses must remain aware of the need to assess the patient’s nares and related symptoms.