Oral Olanzapine Versus Haloperidol or Diazepam

The University of Hong Kong (HKU)

Status and phase: Terminated; Phase 4

Conditions: Behavioural Emergency; Acute Agitation

Treatments: Drug: Diazepam 2Mg encapsulated Tab; Drug: Haloperidol 2Mg encapsulated Tab; Drug: Olanzapine oro-dispersible 5Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT03246620

17111615 (Other Grant/Funding Number)

ChanEW oral sedation RCT

Details and patient eligibility

About

The purpose of this study is to determine whether oral olanzapine is safer (fewer adverse events) and more effective (shorter time to sedation) than conventional haloperidol or diazepam when used in the management of acute agitation in the emergency.

Full description

1. Investigate oral use of sedating drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.
2. The multi-centre Randomised Clinical Trial will determine the safety and efficacy of oral olanzapine, in comparison with conventional medicines (haloperidol or diazepam) in a three-arm comparison for the sedation of acutely agitated patients in AEDs. Specifically, we aim to determine if administration of oral olanzapine (a)is more effective than sedation with oral haloperidol or oral diazepam alone; (b)is safer than sedation with comparison arms; (c)decreases the amount of subsequent redosing or alternative drugs required; (d)is more favourable than the haloperidol and diazepam arms with respect to safety, efficacy and adverse events.

Investigate potential variables leading to AED attendance and/or admission requiring oral sedation. These may include patient demographic and regular medications and adherence.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Accident & Emergency Department patients
• Requiring oral drug sedation (as determined by an emergency clinician) will be enrolled.

Exclusion criteria

• known hypersensitivity or contraindication to the study drugs
• reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
• known pregnancy
• acute alcohol withdrawal
• refusal to take oral medication
• patients from correctional facilities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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12 participants in 3 patient groups

Olanzapine

Experimental group

Description:

oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose

Treatment:

Drug: Olanzapine oro-dispersible 5Mg Tab

Haloperidol

Active Comparator group

Description:

Haloperidol encapsulated tablet, 2 mg tablet, single dose

Treatment:

Drug: Haloperidol 2Mg encapsulated Tab

Diazepam

Active Comparator group

Description:

Diazepam encapsulated tablet, 2mg tablet, single dose

Treatment:

Drug: Diazepam 2Mg encapsulated Tab