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Title: Controlled-Release Oxycodone vs. Placebo in the Treatment of Chronic Breathlessness-A Multisite Randomized Placebo Controlled Trial.
Austin Authors: Ferreira, Diana H;Louw, Sandra;McCloud, Philip;Fazekas, Belinda;McDonald, Christine F ;Agar, Meera R;Clark, Katherine;McCaffrey, Nikki;Ekström, Magnus;Currow, David C
Affiliation: Deakin Health Economics, School of Health and Social Development, Deakin University, Melbourne, Victoria, Australia
Department of Clinical Sciences Lund, Lund University, Faculty of Medicine, Respiratory Medicine and Allergology, Lund, Sweden..
McCloud Consulting Group, Narabang Way, Belrose, New South Wales, Australia
Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia
IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia
Austin Health
University of Melbourne, Parkville, Victoria, Australia
Northern Sydney Local Health District, St Leonards, New South Wales, Australia
University of Sydney, Glebe, New South Wales, Australia
Issue Date: Mar-2020 2019-10-23
Publication information: Journal of Pain and Symptom Management 2020; 59(3): 581-589
Abstract: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated. Does oxycodone reduce chronic breathlessness compared with placebo? A 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 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. Of 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). There 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.
DOI: 10.1016/j.jpainsymman.2019.10.017
PubMed URL: 31655189
Type: Journal Article
Subjects: Chronic breathlessness
effectiveness study
palliative care
placebo study
randomized controlled trial
symptom control
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