Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study

Alexandre Demoule, Robin Deleris, Côme Bureau, Said Lebbah, Maxens Decavèle, Martin Dres, Thomas Similowski, Agnes Dechartres, Alexandre Demoule, Robin Deleris, Côme Bureau, Said Lebbah, Maxens Decavèle, Martin Dres, Thomas Similowski, Agnes Dechartres

Abstract

Background: Dyspnea is common and severe in intensive care unit (ICU) patients managed for acute respiratory failure. Dyspnea appears to be associated with impaired prognosis and neuropsychological sequels. Pain and dyspnea share many similarities and previous studies have shown the benefit of morphine on dyspnea in patients with end-stage onco-hematological disease and severe heart or respiratory disease. In these populations, morphine administration was safe. Here, we hypothesize that low-dose opioids may help to reduce dyspnea in patients admitted to the ICU for acute respiratory failure. The primary objective of the trial is to determine whether the administration of low-dose titrated opioids, compared to placebo, in patients admitted to the ICU for acute respiratory failure with severe dyspnea decreases the mean 24-h intensity of dyspnea score.

Methods: In this single-center double-blind randomized controlled trial with 2 parallel arms, we plan to include 22 patients (aged 18-75 years) on spontaneous ventilation with either non-invasive ventilation, high flow oxygen therapy or standard oxygen therapy admitted to the ICU for acute respiratory failure with severe dyspnea. They will be assigned after randomization with a 1:1 allocation ratio to receive in experimental arm administration of low-dose titrated morphine hydrochloride for 24 h consisting in an intravenous titration relayed subcutaneously according to a predefined protocol, or a placebo (0.9% NaCl) administered according to the same protocol in the control arm. The primary endpoint is the mean 24-h dyspnea score assessed by a visual analog scale of dyspnea.

Discussion: To our knowledge, this study is the first to evaluate the benefit of opioids on dyspnea in ICU patients admitted for acute respiratory failure.

Trial registration: ClinicalTrials.gov NCT04358133 . Registered on 24 April 2020.

Keywords: Dyspnea; Intensive care; Mechanical ventilation; Opioids; Randomized controlled trial.

Conflict of interest statement

A Demoule reports grants, personal fees and non-financial support from Philips, personal fees from Baxter, personal fees and non-financial support from Fisher & Paykel, grants from the French Ministry of Health, personal fees from Getinge, grants, personal fees and non-financial support from Respinor, grants, personal fees and non-financial support from Lungpacer, personal fees from Lowenstein, personal fees from Gilead, outside the submitted work. M Decavèle reports non-financial support (congress registration) from ISIS Medical, outside the submitted work. M Dres reports personal fees and non-financial support from Lungpacer, outside the submitted work. R Deleris, C Bureau, S Lebbah, T Similowski, and A Dechartres report non-conflict of interest.

© 2022. The Author(s).

Figures

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Fig. 1
Trial study design

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Source: PubMed

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