Skip to main content
OpenTrials
Completed

NCT Number: NCT04358133

Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Failure Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Groupe Hospitalier Pitié Salpetriere

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≤ 75 years
  • Admitted in intensive care for an acute respiratory failure defined as a respiratory rate> 24 / min or signs of respiratory distress such as labored breathing or paradoxical inspiration, or SpO2 <90% in ambient air
  • Spontaneous ventilation, either under standard oxygen, high flow oxygen or non invasive ventilation
  • Dyspnea ≥ 40 on an dyspnea-VAS from zero (no dyspnea) to 100 (worst possible dyspnea)
  • Richmond agitation and sedation scale (RASS) between 0 and 2.
  • No confusion, as defined by the CAM-ICU
  • Signed informed consent

Exclusion criteria

  • Intubated patient
  • Intubation planned upon admission
  • Hearing or visual impairment
  • Insufficient command of French
  • Previous psychiatric or cognitive disorders known
  • Moribund patient
  • Known hypersensitivity to opioids
  • Severe renal insufficiency (creatinine clearance <30 ml / min)
  • Severe hepatocellular insufficiency (factor V <50%)
  • Any formal contra-indication of opiates
  • Opioid use within the 24 hours before inclusion
  • Pregnancy or breastfeeding
  • Minor and protected adult
  • Exclusion period due to inclusion in another clinical trial
  • Previous inclusion in this study
  • No affiliation to social security

Treatment and study plan

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

NaCl 0,9%,

Drug

The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm

Primary outcomes

  1. Average dyspnea over 24 hours

    Time frame: systematically evaluated every 4 hours over 24 hours and whenever necessary

    Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO).

Secondary outcomes

  1. Intensity of dyspnea

    Time frame: every 4 hours over 24 hours

    patient reported outcome measure (PRO) ; min=0;max=100(worse)

  2. Incidence of severe dyspnea (dyspnea ≥40)

    Time frame: within 24 hours

    patient reported outcome measure (PRO) ; min=0;max=100(worse)

  3. Anxiety

    Time frame: every 4 hours as well as over the first 24 hours

    Patient reported outcome measure (PRO) ; min=0;max=100(worse)

  4. Incidence of moderate to severe anxiety

    Time frame: every 4 hours over 24 hours

    Incidence of moderate to severe anxiety (PRO) ; min=0;max=100(worse)

  5. Intubation rate

    Time frame: within the first 48 hours

    Intubation rate

  6. Vigilance level (Glasgow Coma Scale : impaired alertness defined by Glasgow Coma Scale ≤ 12)

    Time frame: every 4 hours as well as the first 48 hours

    Vigilance level ; GCS : min=3(worse) ;max=15

  7. Incidence of coma

    Time frame: within the first 48 hours

    Incidence of coma

  8. Incidence of delirium

    Time frame: within the first every 4 hours as well as over the first 48 hours

    Incidence of delirium

  9. Respiratory rate

    Time frame: every 4 hours as well as over the first 24 hours

    Respiratory rate

  10. Proportion of patients requiring the transition from one oxygenation technique to another

    Time frame: At the end of the study (12 months)

    Proportion of patients requiring the transition from one oxygenation technique to another

  11. Intensity of pain

    Time frame: every 4 hours

    Patient reported outcome measure (PRO) ; min=0;max=100(worse)

  12. Duration of night sleep the first night

    Time frame: at the end of the first night

    Duration of night sleep the first night (number of hours)

  13. Quality of sleep the first night

    Time frame: at the end of the first night

    Patient reported outcome measure (PRO); min=0;max=100(worse)

  14. Severity of dry eye

    Time frame: in the first 24 hours

    Patient reported outcome criteria (PRO); min=0;max=100(worse)

  15. Severity of dry nose

    Time frame: in the first 24 hours

    Patient reported outcome criteria (PRO); min=0;max=100(worse)

  16. Severity of feeling of gastric distension

    Time frame: in the first 24 hours

    Patient reported outcome criteria (PRO); min=0;max=100(worse)

  17. Constipation

    Time frame: in the first 48 hours

    Constipation (PRO); min=0;max=100(worse)

  18. Nausea

    Time frame: in the first 48 hours

    Patient reported outcome criteria (PRO) ;min=0;max=100(worse)

  19. Nurses' adherence to the protocol

    Time frame: in the first 24 hours

    Nurses' adherence to the protocol (questionnaire)

  20. Nurses' satisfaction with the protocol

    Time frame: in the first 24 hours

    Nurses' satisfaction with the protocol (questionnaire)

  21. Number of non invasive ventilation sessions

    Time frame: in the first 24 hours

    Number of non invasive ventilation sessions

  22. Total duration of non invasive ventilation

    Time frame: in the first 24 hours

    Total duration of non invasive ventilation (number of hours)

  23. Tolerance of non invasive ventilation

    Time frame: in the first 24 hours

    Tolerance of non invasive ventilation (PRO) ;min=0;max=100(worse)

  24. Duration of HFNCO (high-flow nasal canula oxygenation)

    Time frame: in the first 24 hours

    Duration of HFNCO (number of hours)

  25. Tolerance of HFNCO(high-flow nasal canula oxygenation)

    Time frame: in the first 24 hours

    Tolerance of HFNCO : number of adverses events

  26. Duration of standard oxygen

    Time frame: in the first 24 hours

    Duration of standard oxygen (number of hours)

  27. Tolerance of standard oxygen

    Time frame: in the first 24 hours

    Tolerance of standard oxygen : number of adverses events

  28. Any adverse or serious event occurring

    Time frame: within the first 48 hours

    Any adverse or serious event occurring

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: OPIDYS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2020
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.