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J Pain Symptom Manage · Mar 2020
Randomized Controlled TrialControlled-release oxycodone versus placebo in the treatment of chronic breathlessness - a multi-site randomised placebo controlled trial.
- Diana H Ferreira, Sandra Louw, Philip McCloud, Belinda Fazekas, Christine F McDonald, Meera R Agar, Katherine Clark, Nikki McCaffrey, Magnus Ekström, David C Currow, and Australian National Palliative Care Clinical Studies Collaborative (PaCCSC).
- Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.
- J Pain Symptom Manage. 2020 Mar 1; 59 (3): 581-589.
ContextChronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated.ObjectivesDoes oxycodone reduce chronic breathlessness compared with placebo?MethodsA multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less doses/day) was available for both arms as required by one ethics committee overseeing the trial. Recruitment occurred from 2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology, and palliative care services across Australia. Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0-100 mm visual analogue scale) comparing arms Days 5-7. Secondary end points were average and worst breathlessness, quality of life, function, and harms.ResultsOf 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P < 0.001).ConclusionThere was no signal of benefit from oxycodone over placebo. Future research should focus on investigating the existence of an opioid class effect on the reduction of chronic breathlessness.Copyright © 2019 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.
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