Status:
TERMINATED
AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Lariboisière-Saint Louis clinical research unit
Conditions:
Emergence Delirium
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 dep...
Detailed 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...
Eligibility Criteria
Inclusion
- Age 18 to 60 years;
- Agitated Patient whose somatic or psychiatric aetiology cannot be diagnosed in an emergency situation and who need a sedation in a hospital emergency setting due to the presence of unmanageable agitation with 3 major criteria.
- Major criteria :
- Agitation Pain Tolerance Tachypnea ( fr \> 20)
- And 1 minor criteria among :
- Sweating Tactile Hyperthermia Medical care Non compliance Lack of tiring Unusual Strenght Inappropriately clothed, nudity
- • Medical insurance The protocol can start if the THREE major inclusion criteria and ONE of the minor inclusion criteria are checked PRESENT and ALL the non-inclusion criteria are checked no.
Exclusion
- Subjects who meet any of the following criteria will be excluded from randomization into the study:
- Pregnancy
- Prisoners
- Contraindications to intranasal Midazolam or intramuscular Loxapine :
- Hypersensitivity to benzodiazepines or to any of the excipients (Sodium Chloride, Hydrochloric Acid, Sodium Hydroxide, Water for Injection)
- Known hypersensitivity to loxapine or to any of the excipients (Polysorbate 80, propylene glycol, 20% v/v hydrochloric acid, water for injections, Nitrogen (Inert gas)
- Individuals who are in comatose states or have central nervous system (CNS) depression due to alcohol or are taking other depressant drugs
- Individuals with severe depressive states, spastic diseases, and with Parkinson's disease, except in the case of dyskinesias due to levodopa treatment
- In combination with dopamine agonists except levodopa (amantadine, bromocriptine, lisuride, pergolide, piribedil, ropinirole, cabergoline, pramipexole, apomorphine) outside the patient with Parkinson's disease
- Individuals with a history of cerebrovascular accident or epilepsia
- Individuals in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension;
- Individuals with severe cardiac decompensation
- Patients with severe respiratory failure or acute respiratory depression
- Individuals with acute narrow angle glaucoma.
Key Trial Info
Start Date :
April 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2024
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT05324852
Start Date
April 9 2023
End Date
April 23 2024
Last Update
May 28 2024
Active Locations (1)
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1
Hôpital Avicenne
Bobigny, France, 93000