Phase
Condition
N/ATreatment
Intramuscular loxapine
Intranasal midazolam
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 60 years;
Agitated Patient whose somatic or psychiatric aetiology cannot be diagnosed in anemergency situation and who need a sedation in a hospital emergency setting due tothe 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
Exclusion Criteria:
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 (SodiumChloride, 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 withParkinson's disease, except in the case of dyskinesias due to levodopatreatment
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 constitutea 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.
Study Design
Study Description
Connect with a study center
Hôpital Avicenne
Bobigny, 93000
FranceSite Not Available
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