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A pilot study of nasal fentanyl for patient controlled treatment of cancer pain

M. Thronæs, MD, S. Kaasa, MD, PhD, O. Dale, MD, PhD


Background: Slow release (SR) opioids around the clock are the mainstay for moderate to strong cancer pain. This recommendation is not scientifically based. Therefore, a phase 1 pilot study of rapid acting nasal fentanyl (NF) taken on demand as the only opioid for cancer pain to explore feasibility and safety aspects was launched.

Methods: Patients with cancer, naïve to strong opioids but in need of such drugs, were included. They received a test dose of NF before titration (1-5 days) was started. Ten days treatment was followed by 7 days of observation after switching to SR morphine. Pain relief, nausea, sedation, and local irritation were assessed (11-point numeric rating scale [NRS]). Other adverse events (AEs) were also recorded by the patient. Investigator had regular patient telephone contact.

Results: Ten patients were included. The test dose was well tolerated. Venous fentanyl concentrations at 11 minutes after the test dose differed considerably. All subjects completed the titration; six patients the treatment phase. Three serious AEs were reported; all due to hospitalization, none related to NF. A possible adverse drug reaction (hearing abnormalities) was reported. Other adverse effects were minor. NF treatment reduced average pain for the whole group compared to baseline (4.6-3.7 on the 11-point NRS) and pain relief was achieved in 187/230 (81 percent) of NF administrations (reduction of 2 or more on the 11-piont NRS 15 minutes after NF administration).

Conclusion: This explorative study suggests that it is reasonable that the concept of treating pain in patients with cancer using NF on demand can undergo controlled clinical studies.


pain relief, neoplasm, opioids, pain ladder, incident pain, nasal, fentanyl

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