Evidence map›Paper›PMID 39014448›Full record

Trial reportRespiratory research2024

Low dose of morphine to relieve dyspnea in acute respiratory failure: the OpiDys double-blind randomized controlled trial.

Robin Deleris, Côme Bureau, Saïd Lebbah, Maxens Decavèle, Martin Dres, Julien Mayaux, Thomas Similowski, Agnès Dechartres, Alexandre Demoule

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Respiratory research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04358133 (Relieving Dyspnea With Low Dose of Morphine in Patients Admitted to the Intensive Care Unit for an Acute Respiratory Failure), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04358133 phase2completednot on this map

Relieving Dyspnea With Low Dose of Morphine in Patients Admitted to the Intensive Care Unit for an Acute Respiratory Failure: a Double-blind Randomized Controlled Pilot Study

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2020 to 2022Enrolled23ConditionsAcute Respiratory FailureArmsChlorhydrate de morphine, NaCl 0,9%,
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Robin DelerisAP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), F-75013, Paris, France.
Côme BureauAP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), F-75013, Paris, France.
Saïd LebbahDépartement Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Paris, France.
Maxens DecavèleAP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), F-75013, Paris, France.
Martin DresAP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), F-75013, Paris, France.
Julien MayauxAP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), F-75013, Paris, France.
Thomas SimilowskiSorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, F-75005, Paris, France.
Agnès DechartresSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, CIC-1421, F75013, Paris, France.
Alexandre DemouleAP-HP, Groupe Hospitalier Universitaire APHP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive et Réanimation (Département R3S), F-75013, Paris, France. alexandre.demoule@aphp.fr.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMorphine relieves dyspnea in various clinical circumstances. Whether or not this applies to patients admitted to intensive care units (ICUs) for acute respiratory failure (ARF) is unknown. We evaluated the efficacy and safety of low-dose morphine on dyspnea in patients admitted to the ICU for ARF.

methodsIn this single-center, double-blind, phase 2, randomized, controlled trial, we assigned non-intubated adults admitted to the ICU for ARF with severe dyspnea, defined by a visual analog scale for dyspnea (dyspnea-VAS) from zero (no dyspnea) to 100 mm (worst imaginable dyspnea) ≥40 mm, to receive a low dose of Morphine Hydrochloride (intravenous titration followed by subcutaneous relay) or Placebo. All patients received standard therapy, including etiological treatment and non-invasive respiratory support.

resultsTwenty-two patients were randomized, 11 in each group. The average dyspnea (median [interquartile range]) over 24 hours did not significantly differ between the two groups (40 [25 - 43] mm in the Morphine group vs. 40 [36 - 49] mm in the Placebo group, p=0.411). Dyspnea-VAS was lower in the Morphine group than in the Placebo group at the end of intravenous titration (30 [11 - 30] vs. 35 [30 - 44], p=0.044) and four hours later (18 [10 - 29] vs. 50 [30 - 60], p=0.043). The cumulative probability of intubation was higher in the Morphine group than in the Placebo group (p=0.046)

conclusionIn this phase 2 pilot trial, morphine did not improve 24-hour average dyspnea in adult patients with ARF, even though it had a statistically significant immediate effect. Of concern, Morphine use was associated with a higher intubation rate.

trial registrationThe protocol was declared on the ClinicalTrial.gov database (no. NCT04358133) and was published in September 2022.

Indexed as

Analgesics, OpioidDyspneaMorphineAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedRespiratory InsufficiencyTreatment OutcomeAnalgesics, OpioidMorphineAcute respiratory failureDyspneaIntensive care unitIntubationMorphineTrial

Identifiers

PMID39014448
PMCPMC11251226

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.