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.

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.

• Seventy-nine patients completed the study.
• Mean patient age was 55.9 years (SD = 12.3 years).
• Authors did not specify the percentages of females and males in the sample.
• All patients had a cancer diagnosis, but authors did not provide details about cancer type, extent, or treatment.
• All patients were on a fixed schedule of opioids: a dose equal to or greater than 60 mg/day morphine.

• Multisite
• Outpatient
• 35 centers in Europe and India

Randomized, double-blind/double-dummy (DB/DD) crossover study

• E-diary that prompted the patient at specific time points to rate pain on an 11-point scale (0 = no pain, 10 = worst possible pain)
• Numeric scale to measure pain relief
• Self-report, of relief speed and reliability of the nasal spray, by means of a four-point scale that a patient used after completing a 10-item questionnaire

• Per-episode analysis revealed that FPNS consistently provided relief from pain more rapidly than did IRMS (p < 0.05).
• Overall acceptability scores were significantly greater for FPNS than for IRMS at 30 minutes (P < 0.01).
• Only 4.7% of patients withdrew from titration because of adverse effects; no significant nasal effects were reported.
• Overall, the percentage of episodes requiring rescue medication was similar between the two groups: Of all episodes of breakthrough cancer pain, 97% treated with FPNS did not require additional rescue medication and 96.2% treated with IRMS did not require additional rescue medication.
• Overall, only eight patients (six after treatment with FPNS and two after treatment with IRMS) experienced treatment-related adverse effects that resulted in the discontinuation of the study drug.

This is a strong, well-conducted study that demonstrates that FPNS is efficacious, well accepted, and well tolerated by patients with breakthrough cancer pain.

• The study had a small sample size, with fewer than 100 patients.
• Limitations of the study include its relatively short duration and the lack of IRMS titration.

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.