Title

MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)
Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    111
Acute pulmonary edema (APE) is a common condition in the emergency room, associated with considerable mortality. The use of intravenous morphine in the treatment of APE remains controversial and Benzodiazepines have been suggested as an alternative for morphine to relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE.
Study Started
Apr 08
2017
Primary Completion
Dec 31
2020
Study Completion
Dec 31
2020
Results Posted
May 19
2022
Last Update
Jun 09
2022

Drug Midazolam

Dose use according to the product technical sheet

Drug Morphine

Dose use according to the product technical sheet

midazolam Experimental

The dose of midazolam intravenously will be of 1 mg which may be repeated until a total dose of 3 mg.

morphine Active Comparator

The dose of morphine intravenously is of 2-4 mg which may be repeated until a total dose of 8 mg if the patient continue suffering from severe anxiety or distress caused by APE

Criteria

Inclusion Criteria:

Patients with acute pulmonary edema with dyspnoea and anxiety

Exclusion Criteria:

Patients with known severe liver disease.
Patients with known severe renal disease.
Patients with expectation of death from other illness during the course of the trial.

Summary

Midazolam

Morphine

All Events

Event Type Organ System Event Term Midazolam Morphine

In-hospital Mortality

In hospital mortality

Midazolam

Morphine

Number of Participants That Required Invasive Mechanical Ventilation

Midazolam

3.0
participants

Morphine

1.0
participants

Length of Hospital Stay

Length of hospital stay

Midazolam

7.0
days (Median)
Inter-Quartile Range: 5.0 to 14.0

Morphine

6.0
days (Median)
Inter-Quartile Range: 4.0 to 13.0

Total

111
Participants

Age, Continuous

79.15
years (Median)
Inter-Quartile Range: 71.8 to 83.5

Age, Categorical

Race (NIH/OMB)

Sex: Female, Male

Overall Study

Midazolam

Morphine