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

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: loxapine, midazolam Biological: blood sample Other: patient monitoring Drug: Loxapine Drug: Midazolam	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

Success of treatment at 20 min [ Time Frame: 20 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Success of treatment at 40 and 60 min [ Time Frame: 40 and 60 mn ] [ Designated as safety issue: No ]
Agitation level at 20,40 and 60 min [ Time Frame: 20, 40 and 60mn ] [ Designated as safety issue: No ]
Need for rescue medication [ Time Frame: any time ] [ Designated as safety issue: No ]
Sedation duration [ Time Frame: not available ] [ Designated as safety issue: No ]
treatment failure [ Time Frame: one hour after treatment ] [ Designated as safety issue: No ]


Estimated Enrollment:	120
Study Start Date:	December 2005
Estimated Study Completion Date:	October 2007
Estimated Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: loxapine agitated patients were randomly assigned either to loxapine, either to midazolam group	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) Other Names: Loxapac Hypnovel Biological: blood sample was evaluated in patients sedated, alcohol level, blood sugar Other Names: Loxapac Hypnovel 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
Active Comparator: midazolam midazolam is compared to loxapine in terms of efficacy and tolerance	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) Other Names: Loxapac Hypnovel Biological: blood sample was evaluated in patients sedated, alcohol level, blood sugar Other Names: Loxapac Hypnovel 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: Midazolam Midazolam 1 mL / 10 Kg

Arms

Assigned Interventions

Active Comparator: loxapine

agitated patients were randomly assigned either to loxapine, either to midazolam group

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)

Other Names:

Loxapac
Hypnovel

Biological: blood sample

was evaluated in patients sedated, alcohol level, blood sugar

Other Names:

Loxapac
Hypnovel

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

Active Comparator: midazolam

midazolam is compared to loxapine in terms of efficacy and tolerance

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)

Other Names:

Loxapac
Hypnovel

Biological: blood sample

was evaluated in patients sedated, alcohol level, blood sugar

Other Names:

Loxapac
Hypnovel

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: Midazolam

Midazolam 1 mL / 10 Kg

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


France
Emergency Department
Creteil, Paris, France
Emergency Department
Ghps, Paris, France
Emergency Department
Agen, France, 47923
Emergecy department
Argenteuil, France, 95100
Emergency Department
Bayeux, France, 74401
Emergency Department
Bondy, France, 93143
Emergency Department
Carcassonne, France, 11890
Emergency Department
Clermont-ferrand, France, 63003
Emergency Department
Dijon, France, 11890
Emergency Department
Elbeuf, France, 76503
Emergency Department
Grenoble, France, 38043
Emergency Department
Kremlin Bicetre, France, 94275
Emergency Department
Le Havre, France
Emergency Department
Le Mans, France, 72037
Emergency Department
Lisieux, France, 97223
Emergency Department
Montauban, France, 82013
Emergency Department
Nantes, France, 44093
Emergency Department
Pontoise, France, 95301
Emergency Department
Raincy-Montfermeil, France, 93370
Emergency Department
Roanne, France, 43328
Emergency Department
St Etienne, France, 42055

Sponsors and Collaborators

University Hospital, Rouen

Investigators


Principal Investigator:	Fabienne FM Moritz, MD	University Hospital, Rouen

More Information

No publications provided


Responsible Party:	CHU-Hopitaux de Rouen, Delegation de la recherche clinique
ClinicalTrials.gov Identifier:	NCT00290082 History of Changes
Other Study ID Numbers:	2004/055/HP, French state grant
Study First Received:	February 9, 2006
Last Updated:	March 22, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:


sedation midazolam loxapine	agitation emergency department toxicological analysis

Additional relevant MeSH terms:


Loxapine Midazolam Adjuvants, Anesthesia Anesthetics Anesthetics, General Anesthetics, Intravenous Anti-Anxiety Agents Antipsychotic Agents Central Nervous System Agents Central Nervous System Depressants Dopamine Agents	Dopamine Antagonists GABA Agents GABA Modulators Hypnotics and Sedatives Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015