Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)

Official Title
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Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

Conditions
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Acute Agitated Patients

Intervention / Treatment
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* Drug: loxapine, midazolam
* Biological: blood sample
* Other: patient monitoring
* Drug: Loxapine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old Exclusion Criteria: Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: loxapine<br>agitated patients were randomly assigned either to loxapine, either to midazolam group | Drug: loxapine, midazolam<br>* 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)<br>* Other names: Hypnovel;Biological: blood sample<br>* was evaluated in patients sedated, alcohol level, blood sugar<br>* Other names: Hypnovel;Other: patient monitoring<br>* 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.<br>Drug: Loxapine<br>* Loxapine 1 mL / 10 kg<br>|
| Active Comparator: midazolam<br>midazolam is compared to loxapine in terms of efficacy and tolerance | Drug: loxapine, midazolam<br>* 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)<br>* Other names: Hypnovel;Biological: blood sample<br>* was evaluated in patients sedated, alcohol level, blood sugar<br>* Other names: Hypnovel;Other: patient monitoring<br>* 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.<br>Drug: Midazolam<br>* Midazolam 1 mL / 10 Kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of treatment at 20 min |  | 20 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of treatment at 40 and 60 min |  | 40 and 60 mn | 
| Agitation level at 20,40 and 60 min |  | 20, 40 and 60mn | 
| Need for rescue medication |  | any time | 
| Sedation duration |  |  | 
| treatment failure |  | one hour after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, midazolam, loxapine, agitation, emergency department, toxicological analysis