MedTrace Logo

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

NCT00290082 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-03-11

No results posted yet for this study

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.

Conditions

  • Acute Agitated Patients

Interventions

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

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Fabienne FM Moritz, MD · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290082 on ClinicalTrials.gov