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MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

A

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)

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

Trial documents
2

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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