Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication. However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam. The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
was evaluated in patients sedated, alcohol level, blood sugar
Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
Emergency Department
Créteil, Paris, France
Emergency Department
Ghps, Paris, France
Success of treatment at 20 min
Time frame: 20 min
Success of treatment at 40 and 60 min
Time frame: 40 and 60 mn
Agitation level at 20,40 and 60 min
Time frame: 20, 40 and 60mn
Need for rescue medication
Time frame: any time
Sedation duration
treatment failure
Time frame: one hour after treatment
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Loxapine 1 mL / 10 kg
Midazolam 1 mL / 10 Kg
Emergency Department
Agen, France
Emergecy department
Argenteuil, France
Emergency Department
Bayeux, France
Emergency Department
Bondy, France
Emergency Department
Carcassonne, France
Emergency Department
Clermont-Ferrand, France
Emergency Department
Dijon, France
Emergency Department
Elbeuf, France
...and 11 more locations