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

Acute Agitated Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00290082
• Other study ID #: 2004/055/HP
• Secondary ID: French state gra
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2006
• Last updated: March 10, 2015
• Start date: December 2005
• Est. completion date: October 2007

Study information

• Verified date: March 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Agitated Patients
• Psychomotor Agitation

Intervention

Drug:
• 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)

Biological:
• blood sample
was evaluated in patients sedated, alcohol level, blood sugar

Other:
• 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.

Drug:
• Loxapine
Loxapine 1 mL / 10 kg
• Midazolam
Midazolam 1 mL / 10 Kg

Locations

Country	Name	City	State
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	Creteil	Paris
France	Emergency Department	Dijon
France	Emergency Department	Elbeuf
France	Emergency Department	Ghps	Paris
France	Emergency Department	Grenoble
France	Emergency Department	Kremlin Bicetre
France	Emergency Department	Le Havre
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	St Etienne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of treatment at 20 min		20 min	No
Secondary	Success of treatment at 40 and 60 min		40 and 60 mn	No
Secondary	Agitation level at 20,40 and 60 min		20, 40 and 60mn	No
Secondary	Need for rescue medication		any time	No
Secondary	Sedation duration			No
Secondary	treatment failure		one hour after treatment	No