Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study
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...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06754-3 |
| _version_ | 1797998154900045824 |
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| author | Alexandre Demoule Robin Deleris Côme Bureau Said Lebbah Maxens Decavèle Martin Dres Thomas Similowski Agnes Dechartres |
| author_facet | Alexandre Demoule Robin Deleris Côme Bureau Said Lebbah Maxens Decavèle Martin Dres Thomas Similowski Agnes Dechartres |
| author_sort | Alexandre Demoule |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T10:44:06Z |
| format | Article |
| id | doaj.art-27803f3b984f4ad7a86d7405c30cd140 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T10:44:06Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-27803f3b984f4ad7a86d7405c30cd1402022-12-22T04:29:06ZengBMCTrials1745-62152022-09-012311910.1186/s13063-022-06754-3Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled studyAlexandre Demoule0Robin Deleris1Côme Bureau2Said Lebbah3Maxens Decavèle4Martin Dres5Thomas Similowski6Agnes Dechartres7Service de Médecine Intensive et Réanimation (Département R3S), AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-SalpêtrièreService de Médecine Intensive et Réanimation (Département R3S), AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-SalpêtrièreService de Médecine Intensive et Réanimation (Département R3S), AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-SalpêtrièreDépartement de Santé Publique, Unité de Recherche Clinique Pitié-Sapêtrière-Charles Foix, APHP.Sorbonne Université, site Pitié-SalpêtrièreService de Médecine Intensive et Réanimation (Département R3S), AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-SalpêtrièreService de Médecine Intensive et Réanimation (Département R3S), AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-SalpêtrièreSorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et CliniqueDépartement de Santé Publique, Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, APHP.Sorbonne Université, Hôpital Pitié SalpêtrièreAbstract 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.https://doi.org/10.1186/s13063-022-06754-3DyspneaOpioidsIntensive careMechanical ventilationRandomized controlled trial |
| spellingShingle | Alexandre Demoule Robin Deleris Côme Bureau Said Lebbah Maxens Decavèle Martin Dres Thomas Similowski Agnes Dechartres Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study Trials Dyspnea Opioids Intensive care Mechanical ventilation Randomized controlled trial |
| title | Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study |
| title_full | Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study |
| title_fullStr | Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study |
| title_full_unstemmed | Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study |
| title_short | Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study |
| title_sort | low dose of morphine to relieve dyspnea in acute respiratory failure opidys protocol for a double blind randomized controlled study |
| topic | Dyspnea Opioids Intensive care Mechanical ventilation Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-022-06754-3 |
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