To relieve dyspnea with low dose titration of morphine in patients admitted to intensive care for acute respiratory failure

To relieve dyspnea with low dose titration of morphine in patients admitted to intensive care for acute respiratory failure: A pilot study - OPIDYS - OPIDYS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003091-39-FR

Enrollment

Registered

2019-11-04

Start date

2020-02-10

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients admitted to intensive care for ARI: severe dyspnea (defined by a visual analogue dyspnea scale (EVA-dyspnea) = 40)

Interventions

Trade Name: MORPHINE (CHLORHYDRATE) LAVOISIER 10 mg/ml, solution injectable Product Name: MORPHINE (CHLORHYDRATE) LAVOISIER 10 mg/ml, solution injectable Pharmaceutical Form: Solution for injection P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients = 75 years - Admitted to resuscitation for an IRA defined as a respiratory rate> 24 / min or signs of respiratory distress such as a draw or paradoxical inspiration, or SpO2 =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Intensity of dyspnea every 4 hours (PRO) - Incidence of severe dyspnea (EVA-dyspnea =40) within 24 hours (PRO) - Anxiety (anxiety EVA) every 4 hours as well as on the first 24 hours (PRO) - Incidence of moderate to severe anxiety every 4 hours (PRO) - Intubation in the first 48 hours - Level of vigilance (Glasgow Coma Scale every 4 hours as well as the first 48 hours: impairment of vigilance defined by a Glasgow Coma Scale = 12 - Incidence of coma over the first 48 hours - Incidence of delirium (CAM-ICU) every 4 hours and the first 48 hours - Respiratory rate every 4 hours and on the first 24 hours - Proportion of patients requiring the switch from one oxygenation technique to another - Intensity of pain every 4 hours (PRO) - Duration of night sleep the first night - Quality of sleep the first night (PRO) - Severity of dry eye over the first 24 hours (PRO) - Severity of nasal dryness over the first 24 hours (PRO) - Severity of feeling of gastric distension over the first 24 hours (PRO) - Constipation on the first 48 hours - Nausea over the first 48 hours (PRO) - Accession of nurses to the protocol - Nurses' satisfaction with the protocol - Number of NIV sessions over the first 24 hours - Total duration of the NIV on the first 24 hours - Tolerance of NIV over the first 24 hours - Duration of HFNCO on the first 24 hours - Tolerance of HFNCO over the first 24 hours - Duration of standard oxygen over the first 24 hours - Standard oxygen tolerance over the first 24 hours - Any undesirable or serious event occurring during the first 48 hours. Treatments received by the patient will be collected and described.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether the administration of low-dose titrated opioids compared to placebo in patients admitted to ARI intensive care with severe dyspnea (defined as a visual dyspnoea scale (EVA-dyspnea) = 40) decreases the average 24-hour dyspnoea score (EVA-dyspnea). ;Secondary Objective: To evaluate the impact of low dose opioid administration compared to placebo on the following criteria: - Incidence of severe dyspnea (EVA-dyspnea = 40) and its intensity within 24 hours - Incidence and severity of anxiety every 4 hours - Level of alertness every 4 hours - Incidence of delirium, incidence of coma during the first 24 hours - Respiratory rate every 4 hours - Rate of change from one oxygenation technique to another - Intensity of pain every 4 hours - Duration of sleep and quality on the first night - Signs of intolerance to the oxygenation technique, such as dry eye, nasal dryness, sensation of gastric distension - Signs of digestive intolerance to opioids: constipation, nausea - Adherence of nurses to protocol, satisfaction of nurses - Intubation rate within 24 hours - Number and duration of NIV or HFNCO sessions;Primary end point(s): Average dyspnea over 24 hours. Dyspnea will be assessed by EVA-dyspnea (ranging from zero: no dyspnea to 100: worst dyspnea possible) systematically every 4 hours and whenever necessary.;Timepoint(s) of evaluation of this end point: 48 hours after first administration of Morphine, systematic evaluation every 4 hours and whenever necessary	—

Measure

Time frame

Main Objective: To determine whether the administration of low-dose titrated opioids compared to placebo in patients admitted to ARI intensive care with severe dyspnea (defined as a visual dyspnoea scale (EVA-dyspnea) = 40) decreases the average 24-hour dyspnoea score (EVA-dyspnea). ;Secondary Objective: To evaluate the impact of low dose opioid administration compared to placebo on the following criteria: - Incidence of severe dyspnea (EVA-dyspnea = 40) and its intensity within 24 hours - Incidence and severity of anxiety every 4 hours - Level of alertness every 4 hours - Incidence of delirium, incidence of coma during the first 24 hours - Respiratory rate every 4 hours - Rate of change from one oxygenation technique to another - Intensity of pain every 4 hours - Duration of sleep and quality on the first night - Signs of intolerance to the oxygenation technique, such as dry eye, nasal dryness, sensation of gastric distension - Signs of digestive intolerance to opioids: constipation, nausea - Adherence of nurses to protocol, satisfaction of nurses - Intubation rate within 24 hours - Number and duration of NIV or HFNCO sessions;Primary end point(s): Average dyspnea over 24 hours. Dyspnea will be assessed by EVA-dyspnea (ranging from zero: no dyspnea to 100: worst dyspnea possible) systematically every 4 hours and whenever necessary.;Timepoint(s) of evaluation of this end point: 48 hours after first administration of Morphine, systematic evaluation every 4 hours and whenever necessary

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate the impact of low dose opioid administration compared to placebo on the following criteria: - Incidence of severe dyspnea (EVA-dyspnea = 40) and its intensity within 24 hours - Incidence and severity of anxiety every 4 hours - Level of alertness every 4 hours - Incidence of delirium, incidence of coma during the first 24 hours - Respiratory rate every 4 hours - Rate of change from one oxygenation technique to another - Intensity of pain every 4 hours - Duration of sleep and quality on the first night - Signs of intolerance to the oxygenation technique, such as dry eye, nasal dryness, sensation of gastric distension - Signs of digestive intolerance to opioids: constipation, nausea - Adherence of nurses to protocol, satisfaction of nurses - Intubation rate within 24 hours - Number and duration of NIV or HFNCO sessions ;Timepoint(s) of evaluation of this end point: first 48 hours after administration of morphine	—

Measure

Time frame

Secondary end point(s): To evaluate the impact of low dose opioid administration compared to placebo on the following criteria: - Incidence of severe dyspnea (EVA-dyspnea = 40) and its intensity within 24 hours - Incidence and severity of anxiety every 4 hours - Level of alertness every 4 hours - Incidence of delirium, incidence of coma during the first 24 hours - Respiratory rate every 4 hours - Rate of change from one oxygenation technique to another - Intensity of pain every 4 hours - Duration of sleep and quality on the first night - Signs of intolerance to the oxygenation technique, such as dry eye, nasal dryness, sensation of gastric distension - Signs of digestive intolerance to opioids: constipation, nausea - Adherence of nurses to protocol, satisfaction of nurses - Intubation rate within 24 hours - Number and duration of NIV or HFNCO sessions ;Timepoint(s) of evaluation of this end point: first 48 hours after administration of morphine

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Countries

France

Contacts

Public ContactDRCI Hôpital Saint Louis

Assistance Publique des Hôpitaux de Paris

riad.baameur@aphp.fr330140 27 55 73

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026