Kosugi, T., Hamada, S., Takigawa, C., Shinozaki, K., Kunikane, H., Goto, F., . . . Eguchi, K. (2014). A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: Efficacy and safety in Japanese cancer patients. Journal of Pain and Symptom Management, 47, 990–1000. 

To examine the efficacy and safety of fentanyl buccal tablets (FBT) for treating breakthrough pain in patients with cancer

A dose titration of FBT was administered a maximum of four times. If ineffective, FBT was titrated to the next dose. In this double-blind study, nine tablets were prescribed, six being BTP and three a placebo. One tablet was taken per episode of breakthrough pain.

• N = 136  
• AGE = 20 years or older
• KEY DISEASE CHARACTERISTICS: Cancer-related pain
• OTHER KEY SAMPLE CHARACTERISTICS: Japanese study

• SITE: Multi-site    
• SETTING TYPE: Inpatient    
• LOCATION: Hospitals in Japan

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care and palliative care 

Double-blinded, placebo-controlled study

• Self-recorded pain diary using an 11-point Numeric Rating Scale (NRS)
• Questionnaire of subjects' impression of FBT

A significant difference was observed between the treatment groups and the primary endpoint. The mean was 2.4 for FBT treatment and 2 for the placebo. Regarding the effectiveness of FBT in the questioner survey, 22 and 56 subjects responded that analgesic onset of FBT occurred within 15 or within 15–30 minutes postadministraion.

In this study, FBT was well-tolerated in patients with cancer and was shown to relieve breakthrough pain in patients receiving around-the-clock opioids.

• Among the subjects who started effective dose titration, no effective dose was identified for 28 if the subjects, and 10 subjects did not receive a sufficient effect for breakthrough pain.
• Patients who did not complete the diary were still included.

FBT may be useful in cancer-related breakthrough pain with around-the-clock dosing of opioids.