MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Alberto Dominguez-Rodriguez

Status and phase: Terminated; Phase 4

Conditions: Acute Pulmonary Edema

Treatments: Drug: Morphine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT02856698

EUDRACT: 2016-000884-17

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 2 patient groups

midazolam

Experimental group

Description:

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

Treatment:

Drug: Midazolam

morphine

Active Comparator group

Description:

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

Treatment:

Drug: Morphine