Taylor, D., Galan, V., Weinstein, S.M., Reyes, E., Pupo-Araya, A.R., Rauck, R., & Fentanyl Pectin Nasal Spray 043 Study Group. (2010). Fentanyl pectin nasal spray in breakthrough cancer pain. The Journal of Supportive Oncology, 8(4), 184–190. Retrieved from http://jso.imng.com/jso/journal/articles/0804184.pdf
To determine the efficacy and tolerability of intranasal fentanyl spray (INFS) in the treatment of cancer-related breakthrough pain
Eligible patients went through an open dose-titration phase to determine an effective individual dose of the study drug. In the double-blind phase, patients were given 10 “blinded” bottles containing either the determined dose of INFS or placebo. The bottles were in a randomly assigned sequence. Each patient self-administered a maximum of four doses per day. If relief was inadequate at 30 minutes or if a separate episode of breakthrough pain occurred within a four-hour period, patients could take their usual rescue medication for analgesia. After each treatment episode, subjects recorded relief scores at timed intervals and rated overall satisfaction by means of an electronic diary. Self-reported adverse events were recorded throughout the study, and the study clinician directly assessed nasal condition at the beginning and end of the study.
Randomized double-blind, placebo-controlled multiple-crossover study
INFS is effective for the relief of breakthrough cancer pain for some patients and, as administered in this study, is not associated with severe and prevalent adverse effects.
For the short term, INFS is effective for the management of breakthrough pain episodes for some patients with cancer. Nurses should be aware of the need for assessment of nasal symptoms with INFS use. The fact that slightly more than 20% of patients did not find an effective and tolerable dose of INFS is a reminder that effective pain management, which includes management of breakthrough episodes, needs to be highly individualized to be effective. INFS appears to be a useful part of the set of strategies to manage cancer-related pain. Despite strong evidence from this study, in regard to the immediate effect of INFS, research has not ascertained the effects of long-term INFS use.