Controlled-Release Oxycodone vs. Placebo in the Treatment of Chronic Breathlessness—A Multisite Randomized Placebo Controlled Trial
| Autor: | Diana Ferreira, Christine F McDonald, Belinda Fazekas, David C. Currow, Meera Agar, Philip McCloud, Sandra Louw, Nikki McCaffrey, Magnus Ekström, Katherine Clark |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty Palliative care Visual analogue scale Placebo-controlled study Placebo law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law Internal medicine medicine Clinical endpoint Humans 030212 general & internal medicine General Nursing business.industry Australia Analgesics Opioid Dyspnea Anesthesiology and Pain Medicine Opioid Delayed-Action Preparations 030220 oncology & carcinogenesis Quality of Life Neurology (clinical) business Oxycodone medicine.drug |
| Zdroj: | Journal of Pain and Symptom Management. 59:581-589 |
| ISSN: | 0885-3924 |
| DOI: | 10.1016/j.jpainsymman.2019.10.017 |
| Popis: | Context 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. Objectives Does oxycodone reduce chronic breathlessness compared with placebo? Methods 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 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. Results 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 Conclusion 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. |
| Databáze: | OpenAIRE |
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