TY - JOUR
T1 - Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea
T2 - A Pilot Double-Blind Randomized Controlled Trial
AU - Hui, David
AU - Kilgore, Kelly
AU - Frisbee-Hume, Susan
AU - Park, Minjeong
AU - Liu, Diane
AU - Balachandran, Diwakar D.
AU - Bruera, Eduardo
N1 - Publisher Copyright:
© 2017 American Academy of Hospice and Palliative Medicine
PY - 2017/12
Y1 - 2017/12
N2 - Context Episodic dyspnea is one of the most common, debilitating, and difficult-to-treat symptoms. Objective We conducted a pilot study to examine the effect of prophylactic fentanyl buccal tablet (FBT) on exercise-induced dyspnea. Methods In this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients were asked to complete a six-minute walk test (6MWT) at baseline and then a second 6MWT 30 minutes after a single dose of FBT (equivalent to 20–50% of their total opioid dose) or matching placebo. We compared dyspnea Numeric Rating Scale (NRS, 0–10, primary outcome), walk distance, vital signs, neurocognitive function, and adverse events between the two 6MWTs. Results Among 22 patients enrolled, 20 (91%) completed the study. FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and six minutes (mean change −2.4, 95% CI −3.5, −1.3) and respiratory rate (mean change −2.6, 95% CI −4.7, −0.4). Placebo was also associated with a nonstatistically significant decrease in dyspnea (mean change −1.1). Between-arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate −0.25, P = 0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least “somewhat better” in the second 6MWT (4 of 9 vs. 0 of 11, P = 0.03). The other secondary outcomes did not differ significantly between arms. Conclusions This study supports that prophylactic FBT was associated with a reduction of exertional dyspnea and was well tolerated. Our findings support the need for larger trials to confirm the therapeutic potential of rapid-onset opioids.
AB - Context Episodic dyspnea is one of the most common, debilitating, and difficult-to-treat symptoms. Objective We conducted a pilot study to examine the effect of prophylactic fentanyl buccal tablet (FBT) on exercise-induced dyspnea. Methods In this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients were asked to complete a six-minute walk test (6MWT) at baseline and then a second 6MWT 30 minutes after a single dose of FBT (equivalent to 20–50% of their total opioid dose) or matching placebo. We compared dyspnea Numeric Rating Scale (NRS, 0–10, primary outcome), walk distance, vital signs, neurocognitive function, and adverse events between the two 6MWTs. Results Among 22 patients enrolled, 20 (91%) completed the study. FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and six minutes (mean change −2.4, 95% CI −3.5, −1.3) and respiratory rate (mean change −2.6, 95% CI −4.7, −0.4). Placebo was also associated with a nonstatistically significant decrease in dyspnea (mean change −1.1). Between-arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate −0.25, P = 0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least “somewhat better” in the second 6MWT (4 of 9 vs. 0 of 11, P = 0.03). The other secondary outcomes did not differ significantly between arms. Conclusions This study supports that prophylactic FBT was associated with a reduction of exertional dyspnea and was well tolerated. Our findings support the need for larger trials to confirm the therapeutic potential of rapid-onset opioids.
KW - Controlled clinical trials
KW - dyspnea
KW - fentanyl
KW - neoplasms
KW - opioid analgesics
KW - physical exertion
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U2 - 10.1016/j.jpainsymman.2017.08.001
DO - 10.1016/j.jpainsymman.2017.08.001
M3 - Article
C2 - 28803087
AN - SCOPUS:85031098976
SN - 0885-3924
VL - 54
SP - 798
EP - 805
JO - Journal of pain and symptom management
JF - Journal of pain and symptom management
IS - 6
ER -