Randomized Double-Blind Trial of Midazolam and Loxapine in Agitated Patients - Full Text View

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00290082

Purpose

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.

Condition	Intervention	Phase
Acute Agitated Patients	Drug: Intra-muscular sedation Drug: loxapine Drug: midazolam Behavioral: Richard Scale Behavioral: loxapine, midazolam	Phase III

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Loxapine Loxapine succinate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

Success of treatment at 20 min [ Time Frame: 20 min ]

Secondary Outcome Measures:

Success of treatment at 40 and 60 min [ Time Frame: 40 and 60 mn ]
Agitation level at 20,40 and 60 min [ Time Frame: 20, 40 and 60mn ]
Need for rescue medication
Sedation duration Treatment inefficiency
Adverse events [ Time Frame: 15 days ]

Estimated Enrollment:	250
Study Start Date:	December 2005

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290082

Contacts

Contact: Moritz Fabienne, Doctor		fabienne.moritz@chu-rouen.fr
Contact: TESTUT patrice, PhD		patrice.testut@chu-rouen.fr

Locations

France
Emergency Department	Recruiting
St Etienne, France, 42055
Contact: Viallon Alain
Emergency Department	Recruiting
Raincy-Montfermeil, France, 93370
Contact: Raphael Maurice, Doctor
Sub-Investigator: Raphael Maurice, Doctor
Emergency Department	Recruiting
Bayeux, France, 74401
Sub-Investigator: Prevost Fabrice, Doctor
Emergency Department	Recruiting
Bondy, France, 93143
Emergency Department	Recruiting
Montauban, France, 82013
Emergency Department	Recruiting
Kremlin Bicetre, France, 94275
Emergency Department	Recruiting
Carcassonne, France, 11890
Emergency Department	Recruiting
Dijon, France, 11890
Emergency Department	Recruiting
Pontoise, France, 95301
Emergency Department	Recruiting
Nantes, France, 44093
Emergency Department	Recruiting
Le Mans, France, 72037
Emergency Department	Recruiting
Grenoble, France, 38043
Emergency Department	Recruiting
Roanne, France, 43328
Emergency Department	Recruiting
Elbeuf, France, 76503
Emergency Department	Recruiting
Lisieux, France, 97223
Emergency Department	Recruiting
Agen, France, 47923
Emergency Department	Recruiting
Le Havre, France
Emergecy department	Recruiting
Argenteuil, France, 95100
Contact: Legall Catherine, MD ctherine.legall@ch-argenteuil.fr
Principal Investigator: Legall catherine, MD
Emergency Department	Recruiting
clermont-ferrand, France, 63003
Contact: Jehle eric, MD
Principal Investigator: JEHLE Eric, MD
France, Paris
Emergency Department	Recruiting
Creteil, Paris, France
Contact: Herve Gerome, Doctor
Emergency Department	Recruiting
GHPS, Paris, France
Contact: Ray Patrick, Doctor
Sub-Investigator: Ray Patrick, Doctor

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

Fabienne FM Moritz, MD

University Hospital, Rouen

More Information

Study ID Numbers:	2004/055/HP, French state grant
Study First Received:	February 9, 2006
Last Updated:	June 1, 2007
ClinicalTrials.gov Identifier:	NCT00290082
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

sedation
midazolam
loxapine

agitation
emergency department
toxicological analysis

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Loxapine
Neurologic Manifestations
Emergencies

Psychomotor Agitation
Midazolam
Neurobehavioral Manifestations
Dyskinesias

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Psychomotor Disorders
GABA Agents
Dopamine Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009