Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

University Hospital, Rouen

Status and phase: Terminated; Phase 3

Conditions: Acute Agitated Patients

Treatments: Drug: Loxapine; Drug: loxapine, midazolam; Biological: blood sample; Drug: Midazolam; Other: patient monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT00290082

French state grant

2004/055/HP

Details and patient eligibility

About

Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.

However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.

The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

Full description

Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old

Exclusion criteria

Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

loxapine

Active Comparator group

Description:

agitated patients were randomly assigned either to loxapine, either to midazolam group

Treatment:

Drug: Loxapine

Biological: blood sample

Drug: loxapine, midazolam

Other: patient monitoring

midazolam

Active Comparator group

Description:

midazolam is compared to loxapine in terms of efficacy and tolerance

Treatment:

Drug: Midazolam

Biological: blood sample

Drug: loxapine, midazolam

Other: patient monitoring