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Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized
Alexandre Demoule1,2, Robin Deleris3, Côme Bureau3,4
1Service de Médecine Intensive et Réanimation (Département R3S), AP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, F-75013, Paris, France. alexandre.demoule@aphp.fr.
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.
Insights
Low-dose opioids may reduce severe dyspnea in intensive care unit (ICU) patients with acute respiratory failure. This study investigates the efficacy of titrated morphine compared to placebo in reducing 24-hour dyspnea intensity scores.
Area of Science:
- Critical Care Medicine
- Respiratory Medicine
- Pharmacology
Background:
- Dyspnea is a prevalent and severe symptom in intensive care unit (ICU) patients experiencing acute respiratory failure, often linked to poorer prognosis and neuropsychological issues.
- Opioids, specifically morphine, have demonstrated benefits in managing dyspnea in patients with advanced diseases, with established safety profiles in specific populations.
- The potential of low-dose opioids to alleviate dyspnea in ICU patients with acute respiratory failure warrants investigation.
Purpose of the Study:
- To determine if low-dose titrated opioids, compared to placebo, can decrease the mean 24-hour intensity of dyspnea in ICU patients with acute respiratory failure.
- To evaluate the safety and efficacy of low-dose morphine in managing severe dyspnea within the ICU setting.
Main Methods:
- A single-center, double-blind, randomized controlled trial involving 22 adult patients (18-75 years) with acute respiratory failure and severe dyspnea.
- Patients received either low-dose titrated morphine hydrochloride or a placebo (0.9% NaCl) intravenously for 24 hours, following a predefined protocol.
- The primary endpoint was the mean 24-hour dyspnea score, assessed using a visual analog scale.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This study is the first to explore the potential benefits of opioid administration for managing dyspnea in ICU patients admitted for acute respiratory failure.
- Findings may inform future treatment strategies for severe dyspnea in critically ill patients.
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