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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00290082

Enrollment

120

Registered

2006-02-10

Start date

2005-12-31

Completion date

2007-10-31

Last updated

2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Agitated Patients

Keywords

sedation, midazolam, loxapine, agitation, emergency department, toxicological analysis

Brief 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)

Interventions

DRUGloxapine, 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)

BIOLOGICALblood sample

was evaluated in patients sedated, alcohol level, blood sugar

OTHERpatient 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.

DRUGLoxapine

Loxapine 1 mL / 10 kg

DRUGMidazolam

Midazolam 1 mL / 10 Kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Success of treatment at 20 min	20 min

Secondary

Measure	Time frame
Success of treatment at 40 and 60 min	40 and 60 mn
Agitation level at 20,40 and 60 min	20, 40 and 60mn
Need for rescue medication	any time
Sedation duration	—
treatment failure	one hour after treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026