Prophylactic Fentanyl Sublingual Spray for Episodic Exertional Dyspnea in Cancer Patients: A Pilot Double-Blind Randomized Controlled Trial
| Autor: | Ahsan Azhar, Akhila Reddy, Eduardo Bruera, Larry C. Driver, Jane Naberhuis, Ali Haider, Rony Dev, Avery Virgilio, Diane Liu, Kelly Kilgore, David Hui, Shalini Dalal, Farley Hernandez, Liliana Larsson, Suresh K. Reddy |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Adult
Male Physical Exertion Administration Sublingual Vital signs Pilot Projects Walk Test Context (language use) Walking Article law.invention Fentanyl Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Neoplasms medicine Humans 030212 general & internal medicine Adverse effect General Nursing Aged Dose-Response Relationship Drug business.industry Cancer Middle Aged medicine.disease Analgesics Opioid Dyspnea Anesthesiology and Pain Medicine Fentanyl sublingual spray 030220 oncology & carcinogenesis Anesthesia Female Neurology (clinical) Oral Sprays business Neurocognitive medicine.drug |
| Zdroj: | J Pain Symptom Manage |
| Popis: | Context The optimal dose of fentanyl sublingual spray (FSS) for exertional dyspnea has not been determined. Objectives We examined the effect of two doses of prophylactic FSS on exertional dyspnea. Methods In this parallel, dose-finding, double-blind randomized clinical trial, opioid-tolerant cancer patients completed a shuttle walk test at baseline. Patients completed a second shuttle walk test 10 minutes after a single dose of FSS equivalent to either 35%–45% (high dose) or 15%–25% (low dose) of the total daily opioid dose. The primary outcome was change in modified dyspnea Borg scale (0–10) between the first and second shuttle walk tests. Secondary outcomes included adverse events as well as changes in walk distance, vital signs, and neurocognitive function. Results Thirty of the 50 enrolled patients completed the study. High-dose FSS (n = 13) resulted in significantly lower dyspnea (mean change −1.42; 95% CI −2.37, −0.48; P = 0.007) and greater walk distance (mean change 44 m; P = 0.001) compared to baseline. Low-dose FSS (n = 17) resulted in a nonsignificant reduction in dyspnea (mean change −0.47; 95% CI −1.26, 0.32; P = 0.24) and significant increase in walk distance (mean change 24 m; P = 0.01) compared to baseline. Global evaluation showed high-dose group was more likely to report at least somewhat better improvement (64% vs. 24%; P = 0.06). No significant adverse events or detriment to vital signs or neurocognitive function was detected. Conclusion Prophylactic FSS was well tolerated and demonstrated a dose-response relationship in improving both dyspnea and walk distance. High-dose FSS should be tested in confirmatory trials. |
| Databáze: | OpenAIRE |
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