Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
NCT ID: NCT00290082
Last Updated: 2015-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
120 participants
INTERVENTIONAL
2005-12-31
2007-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
loxapine, midazolam
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)
blood sample
was evaluated in patients sedated, alcohol level, blood sugar
patient monitoring
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
Loxapine 1 mL / 10 kg
midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
loxapine, midazolam
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)
blood sample
was evaluated in patients sedated, alcohol level, blood sugar
patient monitoring
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.
Midazolam
Midazolam 1 mL / 10 Kg
Interventions
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loxapine, midazolam
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)
blood sample
was evaluated in patients sedated, alcohol level, blood sugar
patient monitoring
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
Loxapine 1 mL / 10 kg
Midazolam
Midazolam 1 mL / 10 Kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Delegation de la recherche clinique
Principal Investigators
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Fabienne FM Moritz, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Emergency Department
Créteil, Paris, France
Emergency Department
Ghps, Paris, France
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
Emergency Department
Grenoble, , France
Emergency Department
Le Havre, , France
Emergency Department
Le Kremlin-Bicêtre, , France
Emergency Department
Le Mans, , France
Emergency Department
Lisieux, , France
Emergency Department
Montauban, , France
Emergency Department
Nantes, , France
Emergency Department
Pontoise, , France
Emergency Department
Raincy-Montfermeil, , France
Emergency Department
Roanne, , France
Emergency Department
Saint-Etienne, , France
Countries
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Other Identifiers
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French state grant
Identifier Type: -
Identifier Source: secondary_id
2004/055/HP
Identifier Type: -
Identifier Source: org_study_id
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