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Intranasal Fentanyl Versus Placebo for Treatment of Episodic Breathlessness in Hospice Patients With Advanced Nonmalignant Diseases
- Source :
- Journal of pain and symptom management. 61(5)
- Publication Year :
- 2020
-
Abstract
- Context Episodic breathlessness is a distressing and difficult to treat symptom because of its short duration. Fast actioned intranasal fentanyl (INF) is potentially more suitable than oral opioids. Objectives To examine the feasibility, preliminary efficacy, and safety of INF for the treatment of episodic breathlessness from advanced nonmalignant conditions in hospice patients. Methods Phase IIB, double-blind, randomized controlled, multisite, INF citrate solution vs. placebo crossover feasibility study. Opioid-tolerant patients were to treat six episodes of breathlessness using INF spray. The primary outcome was change in the Visual Analogue Scale for dyspnea (VAS-D) score from baseline to 15 minutes after study drug's administration (VAS-D15). Other outcomes were to collect demographic data and determine the use of rescue medications, safety, and feasibility of the study design. Results Twenty-one of 49 eligible patients were enrolled, and 19 (90%) patients completed the study. The mean difference in VAS-D15 between fentanyl and placebo was −3.37 mm (95% CI = −10.35 to 3.61 mm; P = 0.337). There was no statistically significant or clinically meaningful difference between INF and placebo in relieving the sensation of discomfort in episodic breathlessness. No significant drug-related adverse event or detrimental effect on vital signs was observed. Conclusion We found no difference between INF and placebo in relieving episodic breathlessness in nonmalignant conditions. INF was well tolerated, and the study design proved to be feasible in hospice patients with advanced diseases. Future study using higher concentration of fentanyl solution may be warranted.
- Subjects :
- medicine.medical_specialty
Visual analogue scale
Vital signs
Context (language use)
Placebo
Fentanyl
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Internal medicine
Neoplasms
parasitic diseases
medicine
Humans
030212 general & internal medicine
Adverse effect
General Nursing
Study drug
business.industry
Hospices
Analgesics, Opioid
Anesthesiology and Pain Medicine
Dyspnea
030220 oncology & carcinogenesis
Nasal administration
Neurology (clinical)
business
medicine.drug
Subjects
Details
- ISSN :
- 18736513
- Volume :
- 61
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Journal of pain and symptom management
- Accession number :
- edsair.doi.dedup.....10656469148a3d186441bba228a3e79f