Clinical trial NCT00290082: Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
Official title: Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Agitated Patients
Keywords: sedation
midazolam
loxapine
agitation
emergency department
toxicological analysis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2006-02-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility 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

Primary outcomes:
measure: Success of treatment at 20 min
timeFrame: 20 min
Secondary outcomes:
measure: Success of treatment at 40 and 60 min
timeFrame: 40 and 60 mn
measure: Agitation level at 20,40 and 60 min
timeFrame: 20, 40 and 60mn
measure: Need for rescue medication
timeFrame: any time
measure: Sedation duration
measure: treatment failure
timeFrame: one hour after treatment
Other outcomes:
Locations:
city: Creteil
country: France
facility: Emergency Department
state: Paris
city: Ghps
country: France
facility: Emergency Department
state: Paris
city: Agen
country: France
facility: Emergency Department
city: Argenteuil
country: France
facility: Emergecy department
city: Bayeux
country: France
facility: Emergency Department
city: Bondy
country: France
facility: Emergency Department
city: Carcassonne
country: France
facility: Emergency Department
city: Clermont-ferrand
country: France
facility: Emergency Department
city: Dijon
country: France
facility: Emergency Department
city: Elbeuf
country: France
facility: Emergency Department
city: Grenoble
country: France
facility: Emergency Department
city: Kremlin Bicetre
country: France
facility: Emergency Department
city: Le Havre
country: France
facility: Emergency Department
city: Le Mans
country: France
facility: Emergency Department
city: Lisieux
country: France
facility: Emergency Department
city: Montauban
country: France
facility: Emergency Department
city: Nantes
country: France
facility: Emergency Department
city: Pontoise
country: France
facility: Emergency Department
city: Raincy-Montfermeil
country: France
facility: Emergency Department
city: Roanne
country: France
facility: Emergency Department
city: St Etienne
country: France
facility: Emergency Department
Study officials:
affiliation: University Hospital, Rouen
name: Fabienne FM Moritz, MD
role: PRINCIPAL_INVESTIGATOR
References: