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

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

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.

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 min

Agitation 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)

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

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

Starting date: December 2005
Last updated: March 10, 2015