drugset / Trial / NCT05324852
AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine
Phase 3
Terminated
1 enrolled
Assistance Publique - Hôpitaux de Paris
Lariboisière-Saint Louis clinical research unit · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-04-09
- Primary completion
- 2023-04-09
- Completion
- 2024-04-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 5 mg | Intranasal |
| Subject | Midazolam | Small molecule | 10 mg | Intranasal |
| Comparator | loxapine | Small molecule | 100 mg | Intramuscular |