Zecca, E., Brunelli, C., Centurioni, F., Manzoni, A., Pigni, A., & Caraceni, A. (2017). Fentanyl sublingual tablets versus subcutaneous morphine for the management of severe cancer pain episodes in patients receiving opioid treatment: A double-blind, randomized, noninferiority trial. Journal of Clinical Oncology, 35, 759–765.

DOI Link

Study Purpose

To directly compare fentanyl sublingual tablets (FST) and subcutaneous morphine (SCM) in the first 30 minutes of a severe breakthrough pain episode.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive FST or SCM. Placebo was saline solution or a sublingual tablet reproducing the fentanyl preparation. Re-medication was available after 30 minutes for patients who did not achieve at least a 2-point reduction in pain. Average pain scores were obtained at baseline, 10, 20, 30, and 60 minutes. SCM was given at a 5 mg dose, and the dose for FST was 100 mcg. A non-inferiority margin of 1 point on the pain scale was used.

Sample Characteristics

  • N = 113   
  • AGE: Mean = 60 years (range = 23-88)
  • MALES: 48.7%  
  • FEMALES: 51.3%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types; GI and urogenital were most common
  • OTHER KEY SAMPLE CHARACTERISTICS: Current pain of 6 or greater on a 1 to 10 numeric pain scale. Well-controlled background pain for previous 24 hours. Median pain intensity was 7.5 in both groups.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Italy

Phase of Care and Clinical Applications

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

Study Design

Double-blind, double dummy, noninferiority RCT

Measurement Instruments/Methods

Numeric rating scale

Results

Overall there was no significant difference in change of pain intensity between groups; however, non-inferiority of FST was not shown because the difference between groups was less than the margin established for testing. Patients tended to prefer the tablet rather than subcutaneous injection.

Conclusions

Subcutaneous morphine showed slightly better efficacy than the fentanyl tablet for reducing breakthrough pain intensity. Both approaches were effective.

Limitations

Risk of bias (no blinding)

Nursing Implications

This study showed that both fentanyl sublingual tablets and subcutaneous morphine were effective in reducing the intensity of breakthrough pain. Findings here showed slightly better efficacy of the subcutaneous morphine, though patients preferred the tablet.