NCT00290082

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Acute Agitated Patients

Interventions

Type	Name	Description
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
DRUG	Midazolam	Midazolam 1 mL / 10 Kg

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-02-10
• Last updated: 2015-03-11

Locations

21 sites across 1 country: France