The effects of droperidol and olanzepine in addition to midazolam for sedating very agitated patients: a multi-centre, randomised, controlled clinical trial

Phase 4

Completed

• Conditions: severe agitation; Mental Health - Other mental health disorders; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12607000591459
• Lead Sponsor: Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Emergecncy department patients who require chemical sedation as determined by an Emergency Physician or a senior registrar.

Exclusion Criteria

known hypersensitivity to midazolam, droperidol or olanzepine, reversible aetiology for agitation (hypotension, hypoxia, hypoglycaemia), known pregnancy, acute alcohol withdrawal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to sedation as defined by a sedation score of less than or equal to 2 on a 6 point scale (6=highly agitated & violent, 0=asleep)[Adequate sedation will be expected within 60 minutes of commencement of initial drug administration]

Secondary Outcome Measures

Name	Time	Method
eed for re-sedation less than 60 minutes after sedation initially achieved[within 60 minutes of achieving adequate sedation initially]