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Intranasal Midazolam vs Intramuscular Loxapine for Agitation in the Emergency Department
NCT05324852Phase 3
Key facts
- Status
- Terminated
- Start
- Apr 2023
- Primary completion
- Apr 2023
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- midazolam
- Conditions
- agitation
01
Overview
Phase 3, randomised, open-label trial of midazolam in agitation (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Evolution of agitation. Started Apr 2023; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Intranasal midazolam
Midazolam 5mg intranasal
Intramuscular loxapine
Loxapine 100mg intramuscular
03
Who it enrols
Adult patients (18-60) with unmanageable agitation in the ED, excluding pregnancy, severe depression, CNS depression, and specific medical conditions.
04
Endpoints
Primary
Evolution of agitation
Secondary
Incidence of adverse events following the use of loxapine or midazolam
Number of deceased patients
Number, type and severity level of adverse events
level of sedation obtained by loxapine or midazolam
feelings of health providers with Qualitative research
Improvement of agitation
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