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| ID | Type | Description | Link |
|---|---|---|---|
| French state grant |
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2 complications with midazolam
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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.
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| loxapine | Active Comparator | agitated patients were randomly assigned either to loxapine, either to midazolam group |
|
| midazolam | Active Comparator | midazolam is compared to loxapine in terms of efficacy and tolerance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loxapine, midazolam | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Success of treatment at 20 min | 20 min |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne FM Moritz, MD | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department | Créteil | Paris | France | |||
| Emergency Department |
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|
|
| blood sample | Biological | was evaluated in patients sedated, alcohol level, blood sugar |
|
|
| patient monitoring | Other | 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. |
|
| Loxapine | Drug | Loxapine 1 mL / 10 kg |
|
| Midazolam | Drug | Midazolam 1 mL / 10 Kg |
|
| any time |
| Sedation duration |
| treatment failure | one hour after treatment |
| Ghps |
| Paris |
| France |
| Emergency Department | Agen | 47923 | France |
| Emergecy department | Argenteuil | 95100 | France |
| Emergency Department | Bayeux | 74401 | France |
| Emergency Department | Bondy | 93143 | France |
| Emergency Department | Carcassonne | 11890 | France |
| Emergency Department | Clermont-Ferrand | 63003 | France |
| Emergency Department | Dijon | 11890 | France |
| Emergency Department | Elbeuf | 76503 | France |
| Emergency Department | Grenoble | 38043 | France |
| Emergency Department | Le Havre | France |
| Emergency Department | Le Kremlin-Bicêtre | 94275 | France |
| Emergency Department | Le Mans | 72037 | France |
| Emergency Department | Lisieux | 97223 | France |
| Emergency Department | Montauban | 82013 | France |
| Emergency Department | Nantes | 44093 | France |
| Emergency Department | Pontoise | 95301 | France |
| Emergency Department | Raincy-Montfermeil | 93370 | France |
| Emergency Department | Roanne | 43328 | France |
| Emergency Department | Saint-Etienne | 42055 | France |
| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008152 | Loxapine |
| D008874 | Midazolam |
| D001800 | Blood Specimen Collection |
| D000098465 | Remote Patient Monitoring |
| ID | Term |
|---|---|
| D003989 | Dibenzoxazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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