Hui, D., Kilgore, K., Frisbee-Hume, S., Park, M., Liu, D., Balachandran, D.D., & Bruera, E. (2017). Effect of prophylactic fentanyl buccal tablet on episodic exertional dyspnea: A pilot double-blind randomized controlled trial. Journal of Pain and Symptom Management, 54, 798–805.

DOI Link

Study Purpose

To study the effect of fentanyl in preventing dyspnea before exertion.

Intervention Characteristics/Basic Study Process

Opiate-tolerant patients were given a six-minute walk test for baseline, then later given fentanyl or a placebo, waited 30 minutes, then repeated the six-minute walk test. Study measures were then taken between the two arms.

Sample Characteristics

  • N = 20 
  • AGE: Average age = 55 years
  • MALES: 40%  
  • FEMALES: 60%
  • CURRENT TREATMENT: Supportive care
  • KEY DISEASE CHARACTERISTICS: 90% had metastatic disease. All had some concurrent scheduled medications for SOB besides opiates; 0% were used to taking 66-130 mg of morphine a day. SOB of 3-7 on a scale of 10 at rest.
  • OTHER KEY SAMPLE CHARACTERISTICS: Karnofsky level mean was 71. Average fvc = 2.4 L, and fev1 = 1.7 L.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Supportive care clinics

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Double blind randomized placebo controlled trial comparing baseline six-minute walk test and then a second six-minute walk test (6MWT) effects of placebo versus single dose of fentanyl buccal tablet 30 minutes prior to second walk.

Measurement Instruments/Methods

Dyspnea was measured using a modified BORG scale from 0-10, with 10 indicating the worst score. Vital signs of BP: O2 saturation, heart rate, respiratory rate taken before and after the six-minute walk test. Distance walked per minute was recorded. Lung function was only done at baseline. Neurocognitive testing was done before medication and after the second six-minute walk.

Results

No difference with either arm seen for distance walked or fatigue, or vital signs other then respiratory rate between the first and second 6MWTs (mean change = 2.6, 95% CI [0.4, 4.7]) with a trend toward greater level of dyspnea relief compared with placebo (estimate = 0.25, p = 0.068).

Conclusions

Buccal fentanyl had a significant effect in reducing dyspnea then placebo after 30 minutes, when patients exerted themselves.

Limitations

  • Small sample (< 30)

 

Nursing Implications

Nurses caring for patients with dyspnea recognize the need to provide interventions that minimize dyspnea during daily activities, particularly when dyspnea interferes with ADLs and impacts patients' quality of life. Interventions such as prophylactic FBT may enable patients to participate in activities, regain independence, and improve their quality of life without experiencing adverse events such as dizziness, drowsiness, and nausea.