Status:

TERMINATED

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

Lead Sponsor:

University Hospital, Rouen

Conditions:

Acute Agitated Patients

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

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 ind...

Detailed Description

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

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2007

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00290082

Start Date

December 1 2005

End Date

October 1 2007

Last Update

March 11 2015

Active Locations (21)

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Page 1 of 6 (21 locations)

1

Emergency Department

Créteil, Paris, France

2

Emergency Department

Ghps, Paris, France

3

Emergency Department

Agen, France, 47923

4

Emergecy department

Argenteuil, France, 95100