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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003091-39 | EudraCT Number |
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This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. However, to date, data regarding the impact of morphine on dyspnea in intensive care unit patients admitted for acute respiratory failure are scarce. There may be a reluctance of physicians to prescribe opioids that is not scientifically justified.
The study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this pilot study is to design the protocol of a future pragmatic trial.
Randomized, double-blind, placebo-controlled, parallel-group, single-center phase 2 pilot study.The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm Patients will be randomized 1:1 between low-dose titrated morphine (experimental group) and placebo (control group). The other treatments will be similar in both groups, according to the protocol and the recommendations.
Severe dyspnea will be assessed for regularly Patients will be followed for 48 hours: 24-hour treatment duration, evaluation of primary endpoint for first 24 hours, collection of adverse events for 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhydrate de morphine | Experimental | initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea <40 then relay subcut |
|
| NaCl 0,9% | Placebo Comparator | initial dose of 2 mg, followed by 1 mg every 3 minutes until a VAS-dyspnea <40 then relay subcut |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhydrate de morphine | Drug | The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Average dyspnea over 24 hours | Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO). | systematically evaluated every 4 hours over 24 hours and whenever necessary |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of dyspnea | patient reported outcome measure (PRO) ; min=0;max=100(worse) | every 4 hours over 24 hours |
| Incidence of severe dyspnea (dyspnea ≥40) | patient reported outcome measure (PRO) ; min=0;max=100(worse) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre DEMOULE, PH | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié Salpetriere | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39014448 | Derived | Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Mayaux J, Similowski T, Dechartres A, Demoule A. Low dose of morphine to relieve dyspnea in acute respiratory failure: the OpiDys double-blind randomized controlled trial. Respir Res. 2024 Jul 16;25(1):280. doi: 10.1186/s12931-024-02867-2. | |
| 36175968 | Derived |
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Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Randomized, double-blind, placebo-controlled, parallel-group,single center, phase 2 pilot study
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The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm
| NaCl 0,9%, | Drug | The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm |
|
| within 24 hours |
| Anxiety | Patient reported outcome measure (PRO) ; min=0;max=100(worse) | every 4 hours as well as over the first 24 hours |
| Incidence of moderate to severe anxiety | Incidence of moderate to severe anxiety (PRO) ; min=0;max=100(worse) | every 4 hours over 24 hours |
| Intubation rate | Intubation rate | within the first 48 hours |
| Vigilance level (Glasgow Coma Scale : impaired alertness defined by Glasgow Coma Scale ≤ 12) | Vigilance level ; GCS : min=3(worse) ;max=15 | every 4 hours as well as the first 48 hours |
| Incidence of coma | Incidence of coma | within the first 48 hours |
| Incidence of delirium | Incidence of delirium | within the first every 4 hours as well as over the first 48 hours |
| Respiratory rate | Respiratory rate | every 4 hours as well as over the first 24 hours |
| Proportion of patients requiring the transition from one oxygenation technique to another | Proportion of patients requiring the transition from one oxygenation technique to another | At the end of the study (12 months) |
| Intensity of pain | Patient reported outcome measure (PRO) ; min=0;max=100(worse) | every 4 hours |
| Duration of night sleep the first night | Duration of night sleep the first night (number of hours) | at the end of the first night |
| Quality of sleep the first night | Patient reported outcome measure (PRO); min=0;max=100(worse) | at the end of the first night |
| Severity of dry eye | Patient reported outcome criteria (PRO); min=0;max=100(worse) | in the first 24 hours |
| Severity of dry nose | Patient reported outcome criteria (PRO); min=0;max=100(worse) | in the first 24 hours |
| Severity of feeling of gastric distension | Patient reported outcome criteria (PRO); min=0;max=100(worse) | in the first 24 hours |
| Constipation | Constipation (PRO); min=0;max=100(worse) | in the first 48 hours |
| Nausea | Patient reported outcome criteria (PRO) ;min=0;max=100(worse) | in the first 48 hours |
| Nurses' adherence to the protocol | Nurses' adherence to the protocol (questionnaire) | in the first 24 hours |
| Nurses' satisfaction with the protocol | Nurses' satisfaction with the protocol (questionnaire) | in the first 24 hours |
| Number of non invasive ventilation sessions | Number of non invasive ventilation sessions | in the first 24 hours |
| Total duration of non invasive ventilation | Total duration of non invasive ventilation (number of hours) | in the first 24 hours |
| Tolerance of non invasive ventilation | Tolerance of non invasive ventilation (PRO) ;min=0;max=100(worse) | in the first 24 hours |
| Duration of HFNCO (high-flow nasal canula oxygenation) | Duration of HFNCO (number of hours) | in the first 24 hours |
| Tolerance of HFNCO(high-flow nasal canula oxygenation) | Tolerance of HFNCO : number of adverses events | in the first 24 hours |
| Duration of standard oxygen | Duration of standard oxygen (number of hours) | in the first 24 hours |
| Tolerance of standard oxygen | Tolerance of standard oxygen : number of adverses events | in the first 24 hours |
| Any adverse or serious event occurring | Any adverse or serious event occurring | within the first 48 hours |
| Demoule A, Deleris R, Bureau C, Lebbah S, Decavele M, Dres M, Similowski T, Dechartres A. Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study. Trials. 2022 Sep 30;23(1):828. doi: 10.1186/s13063-022-06754-3. |
| D013568 | Pathological Conditions, Signs and Symptoms |