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AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine — AGINASAL  

Emergence Delirium Clinical Trial

Official title:
AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine, a Randomized Non Inferiority Trial

Clinical Trial Summary

This study is a non-inferiority phase III randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. Intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

Clinical Trial Description

This study is a prospective, multicenter, open-label randomized, controlled, parallel-group 2-arm phase III non-inferiority trial. Patients with agitation at emergency department will be randomized to two arms of treatment: one experimental arm with intranasal midazolam 5mg (investigational medicinal product), and one control arm with comparator treatment intramuscular loxapine 100mg. The duration of participation for each patient is at least 28 days (+7 days if follow-up not completed on D28). An endpoint Adjudication Committee will be scheduled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05324852
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact
Status Terminated
Phase Phase 3
Start date April 9, 2023
Completion date April 23, 2024
View Details
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