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

Official Title: “Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department”

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.

Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: loxapine
  • agitated patients were randomly assigned either to loxapine, either to midazolam group
• Active Comparator: midazolam
  • midazolam is compared to loxapine in terms of efficacy and tolerance

Primary Measures

• Success of treatment at 20 min
  • Time Frame: 20 min
    Safety Issue?: No

Secondary Measures

• Success of treatment at 40 and 60 min
  • Time Frame: 40 and 60 mn
    Safety Issue?: No
• Agitation level at 20,40 and 60 min
  • Time Frame: 20, 40 and 60mn
    Safety Issue?: No
• Need for rescue medication
  • Time Frame: any time
    Safety Issue?: No
• Sedation duration
  • Time Frame: not available
    Safety Issue?: No
• treatment failure
  • Time Frame: one hour after treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University Hospital, Rouen Other

Overall Clinical Trial Officials and Contacts

Fabienne FM Moritz, MD Principal Investigator University Hospital, Rouen  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00290082

Study ID Number: 2004/055/HP

ClinicalTrials.gov Identifier: NCT00290082

Health Authority: France: Afssaps - French Health Products Safety Agency