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

A randomised clinical trial to compare the efficacy of intravenous droperidol and olanzepine as adjuncts to midazolam for sedation of the severely agitated patient

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000591459

Enrollment

336

Registered

2007-11-16

Start date

2009-08-12

Completion date

2011-03-27

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

We believe that the addition of either 5mh of droperidol or 5mg olanzapine immediately prior to sedation with midazolam will result in safe and more effective sedation

Interventions

Single intravenous bolus dose of 5mg droperidol (0.5mg/ml) or 5mg olanzapine (0.5mg/ml) immediately prior to sedation with intravenous midazolam

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results