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A single-centre, randomized comparsion of the Efficacy and Safety of Intramuscular Olanzapine and Haloperidol in Treating Acutely Agitated patients in Emergency Department

A single-centre, randomized comparsion of the Efficacy and Safety of Intramuscular Olanzapine and Haloperidol in Treating Acutely Agitated patients in Emergency Department

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000280404
Enrollment
280
Registered
2007-05-28
Start date
2007-08-01
Completion date
Unknown
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

To determine IM olanzapine is more effectivd than haloperidol in treating acutely agitated patients in the emergency department setting

Interventions

Patients are randomized to either olanzapine or haloperidol groups. The study aim is to compare the time for sedation of acutely agitated patients in the olanzapine group (new treatment) with haloperidol group (traditional treatment). The duration of intervention is about 30 minutes after single dose of study drug. The dose of olanzapine and haloperidol are both intramuscularly 10mg. The estimated study period will be approximately one year and the sample size is approx 140 in each study group

Patients are randomized to either olanzapine or haloperidol groups. The study aim is to compare the time for sedation of acutely agitated patients in the olanzapine group (new treatment) with haloperidol group (traditional treatment). The duration of intervention is about 30 minutes after single dose of study drug. The dose of olanzapine and haloperidol are both intramuscularly 10mg. The estimated study period will be approximately one year and the sample size is approx 140 in each study group i.e. 280 subjects in total.

Sponsors

Peninsula Health (Emergency Department)
Lead SponsorHospital

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
No

Inclusion criteria

Acute agitation that required chemical restraint.

Exclusion criteria

Readily reversible aetiology for the agitationhypotensionknown allergy to either drugvisible or suspected head traumaunable to maintain their own airwayin respiratory distressknown pregnancyknown Parkinson's disease or Lewy Body Dementiaaged

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026