Mercadante, S., Ferrera, P., & Arcuri, E. (2011). The use of fentanyl buccal tablets as breakthrough medication in patients receiving chronic methadone therapy: An open label preliminary study. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19(3), 435–438.

DOI Link

Study Purpose

To assess the efficacy of fentanyl buccal tablets (FBTs) for the treatment of breakthrough cancer pain in patients who receive methadone as a background analgesic

Intervention Characteristics/Basic Study Process

Palliative care inpatients receiving 12 mg morphine received 100 mcg FBTs. Proportionally higher doses of FBTs were given according to background methadone dose. Patients requested pain medication from the nurse for breakthrough episodes. Nurses graded pain scores when called and after 15 minutes.

Sample Characteristics

  • The sample was composed of 13 patients.
  • Mean patient age was 58.1 years (SD = 9.9 years). The age range of the sample was 43–75 years.
  • Of the 13 patients, 4 were female and 9 were male.
  • Seven patients had lung cancer, two had pancreas cancer, one had kidney cancer, one had breast cancer, one had prostate cancer, and one had ovarian cancer.
  • All patients were receiving stable doses of oral methadone.
  • All patients were inpatients receiving palliative care.

Setting

  • Single site
  • Inpatient
  • Italy

Study Design

Prospective trial

Measurement Instruments/Methods

  • Numeric pain scale, 0–10
  • Numeric pain intensity scale, 0–10, to measure changes of pain intensity

Results

In the majority of events, 15 minutes after administration of an FBT, evidence showed a decrease in pain intensity greater than 33% and greater than 50% (n = 20, 31.5% and n = 26, 40.6%, respectively). Nine events (14%) were unsuccessfully treated and required IV methadone injection. In all patients, the level of adverse effects after FBT administration was mild and indistinguishable from the level of adverse effects associated with baseline opioid analgesia.

Conclusions

Patients who receive methadone can achieve analgesic effect when FBT is administered for breakthrough cancer pain.

Limitations

The study had a small sample size, with fewer than 30 patients.

Nursing Implications

An FBT lozenge must be rubbed gently against the buccal mucosa until it dissolves completely. For FBT treatment to be effective, patients must be instructed how to do this and they must have the ability to do it. For patients receiving methadone, FBTs may be an effective alternative for treating breakthrough cancer pain.