Koike, K., Terui, T., Nagasako, T., Horiuchi, I., Machino, T., Kusakabe, T., . . . Ishitani, K. (2016). A new once-a-day fentanyl citrate patch (Fentos Tape) could be a new treatment option in patients with end-of-dose failure using a 72-h transdermal fentanyl matrix patch. Supportive Care in Cancer, 24, 1053–1059. 

DOI Link

Study Purpose

To assess effectiveness of a once-a-day fentanyl patch for patients receiving a 72-hour patch that does not last for 72 hours

Intervention Characteristics/Basic Study Process

Patients identified as having end-of-dose failure with a 72-hour fentanyl patch were identified and converted to the once-a-day patch according to manufacturer recommendations. In the evening of the switch day, the new patch was applied immediately after removing the 72-hour patch. Treatment for breakthrough pain was adjusted according to the fentanyl dose, and immediate-release morphine or oxycodone was used for breakthrough pain. If patients were on anti-inflammatories, they remained on this medication. Patients recorded study data daily. Of the patients, 15.6% had the 72-hour patch changed to use every 48 hours. Mean frequency of daily rescue doses for breakthrough pain were analyzed.

Sample Characteristics

  • N = 45   
  • AGE RANGE: 60–69 years
  • MALES: 54.8%, FEMALES: 45.2%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Varied tumor types
  • OTHER KEY SAMPLE CHARACTERISTICS: Most were on 25–50 mcg fentanyl per hour.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care 

Study Design

  • Retrospective cross sectional

Measurement Instruments/Methods

  • Numeric pain rating scale from patient diaries

Results

Of the patients with suspected end-of-dose failure, 84% were switched to the once-a-day patch. The rest had patches switched at 48 rather than 72 hours. On the last day of the 72-hour patch, mean daily dosing for breakthrough pain was 3.61; on the third day after the switch, the mean daily dosing was 1.18 (p < 0.05). Adverse events occurred in 18% of patients with the new patch, including local skin irritation and sensitivity. Of the patients with shortened interval to 48 hours, three showed a decrease in pain score, two showed no change, and two showed increased scores. After the switch to the once-a-day patch, 61% showed more than a 30% reduction in average pain.

Conclusions

Patients switched to the once-a-day fentanyl patch had a reduction in average pain scores and a reduction in rescue medications needed.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • Timing of pain measurement from diaries is not stated.

Nursing Implications

Differentiating between breakthrough pain and end-of-dose pain medication failure is important. This study suggests that these may not always be well determined. Study findings suggest that a once-a-day fentanyl citrate patch may be more effective for pain control than the usual 72-hour fentanyl matrix, particularly in patients with end-of-dose failure. This study is limited by its design and sample size. Further well-designed research is warranted.