Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
Information source: University Hospital, Rouen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Agitated Patients
Intervention: loxapine, midazolam (Drug); blood sample (Biological); patient monitoring (Other); Loxapine (Drug); Midazolam (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: University Hospital, Rouen Official(s) and/or principal investigator(s): Fabienne FM Moritz, MD, Principal Investigator, Affiliation: University Hospital, Rouen
Summary
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.
Clinical Details
Official title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Success of treatment at 20 min
Secondary outcome: Success of treatment at 40 and 60 minAgitation level at 20,40 and 60 min Need for rescue medication Sedation duration treatment failure
Detailed description:
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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, Kremlin Bicetre 94275, France
Emergency Department, Le Havre, 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, St Etienne 42055, France
Emergency Department, Creteil, Paris, France
Emergency Department, Ghps, Paris, France
Additional Information
Starting date: December 2005
Last updated: March 10, 2015
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