IM Olanzapine Versus Haloperidol or Midazolam

The University of Hong Kong (HKU)

Status and phase: Terminated; Phase 4

Conditions: Acute Agitation, Behavioural Emergency

Treatments: Drug: Haloperidol; Drug: Midazolam; Drug: Olanzapine

Study type: Interventional

Funder types: Other

Identifiers

NCT02380118

HKU 789813M (Other Grant/Funding Number)

PR/CT 0309/2014 (SC)

Details and patient eligibility

About

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

Full description

To address significant knowledge gaps by several means:

1. Investigate intramuscular use of sedative drugs within a predominantly Chinese population, to address this void in international literature impacting the management of acute agitation.

   The multi-centre RCT will determine the safety and efficacy of intramuscular olanzapine, in comparison with conventional medicines (haloperidol or midazolam) in a three-arm comparison for the sedation of acutely agitated patients in emergency department. Specifically, we aim to determine if administration of intramuscular olanzapine (a)is more effective than sedation with intramuscular haloperidol or intramuscular midazolam 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 midazolam arms with respect to safety, efficacy and adverse events.

2. Investigate potential variables leading to emergency attendance and/or admission requiring parenteral sedation. These may include patient demographics and regular medications and adherence.

Enrollment: 167 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Emergency Department patients, requiring parenteral drug sedation (as determined by an emergency clinician) will be enrolled.

Exclusion criteria

• Patients will be excluded if there are

  1. known hypersensitivity or contraindication to the study drugs
  2. reversible aetiology for agitation (e.g. hypotension, hypoxia, hypoglycaemia)
  3. known pregnancy
  4. acute alcohol withdrawal
  5. patients aged>75 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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167 participants in 3 patient groups

Olanzapine

Experimental group

Description:

intramuscular olanzapine injection (zyprexa), 5 mg/dose, first dose and an optional second dose.

Treatment:

Drug: Olanzapine

Haloperidol

Active Comparator group

Description:

intramuscular haloperidol injection, 5 mg/dose, first dose and an optional second dose.

Treatment:

Drug: Haloperidol

Midazolam

Active Comparator group

Description:

intramuscular midazolam injection, 5 mg/dose, first dose and an optional second dose.

Treatment:

Drug: Midazolam