%0 Journal Article %T Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study %+ CHU Pitié-Salpêtrière [AP-HP] %+ Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158) %+ Centre d'investigation clinique Paris Est [CHU Pitié Salpêtrière] (CIC Paris-Est) %+ Sorbonne Université (SU) %+ Pharmacoépidémiologie et évaluation des soins [iPLesp] (PEPITES) %+ Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP) %A Demoule, Alexandre %A Deleris, Robin %A Bureau, Côme %A Lebbah, Said %A Decavèle, Maxens %A Dres, Martin %A Similowski, Thomas %A Dechartres, Agnes %Z the study was funded by Assistance Publique – Hôpitaux de Paris (Contrat de Recherche Clinique 2018 CRC18023). %< avec comité de lecture %@ 1745-6215 %J Trials %I BioMed Central %V 23 %N 1 %P 828 %8 2022-12 %D 2022 %R 10.1186/s13063-022-06754-3 %M 36175968 %K Dyspnea %K Intensive care %K Mechanical ventilation %K Opioids %K Randomized controlled trial. %Z Life Sciences [q-bio]Journal articles %X 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. %G English %2 https://inserm.hal.science/inserm-03986378/document %2 https://inserm.hal.science/inserm-03986378/file/s13063-022-06754-3.pdf %L inserm-03986378 %U https://inserm.hal.science/inserm-03986378 %~ INSERM %~ APHP %~ IPLESP %~ U1158 %~ SORBONNE-UNIVERSITE %~ SORBONNE-UNIV %~ SU-MEDECINE %~ SU-MED %~ SU-TI %~ ALLIANCE-SU