Oral Olanzapine Versus Haloperidol or Diazepam

NCT03246620 | Terminated Phase 4 DMC

• 2 other identifiers: ChanEW oral sedation RCT17111615
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Agitation; Behavioural Emergency

Keywords

emergency; emergency medicine; sedation; acute agitation

Outcome Measures

Primary Outcomes (1)

• Time to achieve adequate sedation

  Adequate sedation is determined by a 6-point validated scale

  Within 60 minutes from drug administration

Secondary Outcomes (4)

• Total study drug doses administered; alternative drugs and doses used

  From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour

• Corrected QT interval (QTc)

  From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour

• AED length of stay (LOS)

  From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour

• Adverse events

  From Accident & Emergency Department(AED) admission to transfer or discharge from AED, an expected average of 1 hour

Study Arms (3)

Olanzapine

EXPERIMENTAL

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

Drug: Olanzapine oro-dispersible 5Mg Tab

Haloperidol

ACTIVE COMPARATOR

Haloperidol encapsulated tablet, 2 mg tablet, single dose

Drug: Haloperidol 2Mg encapsulated Tab

Diazepam

ACTIVE COMPARATOR

Diazepam encapsulated tablet, 2mg tablet, single dose

Drug: Diazepam 2Mg encapsulated Tab

Interventions

Olanzapine oro-dispersible 5Mg Tab DRUG

Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet

Also known as: Zyprexa

Olanzapine

Haloperidol 2Mg encapsulated Tab DRUG

Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet

Haloperidol

Diazepam 2Mg encapsulated Tab DRUG

Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet

Diazepam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Elizabeth Hospital, Hong Kong: collaborator

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Related Publications (8)

• Knott JC, Bennett D, Rawet J, Taylor DM. Epidemiology of unarmed threats in the emergency department. Emerg Med Australas. 2005 Aug;17(4):351-8. doi: 10.1111/j.1742-6723.2005.00756.x.

  PMID: 16091097 BACKGROUND

• Chan EW, Taylor DM, Knott JC, Phillips GA, Castle DJ, Kong DC. Intravenous droperidol or olanzapine as an adjunct to midazolam for the acutely agitated patient: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Ann Emerg Med. 2013 Jan;61(1):72-81. doi: 10.1016/j.annemergmed.2012.07.118. Epub 2012 Sep 13.

  PMID: 22981685 BACKGROUND

• Knott JC, Taylor DM, Castle DJ. Randomized clinical trial comparing intravenous midazolam and droperidol for sedation of the acutely agitated patient in the emergency department. Ann Emerg Med. 2006 Jan;47(1):61-7. doi: 10.1016/j.annemergmed.2005.07.003. Epub 2005 Aug 18.

  PMID: 16387219 BACKGROUND

• Chan EW, Taylor DM, Knott JC, Kong DC. Variation in the management of hypothetical cases of acute agitation in Australasian emergency departments. Emerg Med Australas. 2011 Feb;23(1):23-32. doi: 10.1111/j.1742-6723.2010.01348.x. Epub 2010 Nov 22.

  PMID: 21091874 BACKGROUND

• Chan EW, Knott JC, Taylor DM, Phillips GA, Kong DC. Intravenous olanzapine--another option for the acutely agitated patient? Emerg Med Australas. 2009 Jun;21(3):241-2. doi: 10.1111/j.1742-6723.2009.01190.x. No abstract available.

  PMID: 19527287 BACKGROUND

• Chan EW, Taylor DM, Knott JC, Liew D, Kong DC. The pharmacoeconomics of managing acute agitation in the emergency department: what do we know and how do we approach it? Expert Rev Pharmacoecon Outcomes Res. 2012 Oct;12(5):589-95. doi: 10.1586/erp.12.53.

  PMID: 23186399 BACKGROUND

• Chan EW, Tang C, Lao KS, Ling Pong L, Tsui MS, Ho HF, Wong GC, Kong DC, McD Taylor D, Knott JC, Wong IC. Management of acute agitation in Hong Kong and comparisons with Australasia. Emerg Med Australas. 2015 Dec;27(6):542-548. doi: 10.1111/1742-6723.12499. Epub 2015 Dec 3.

  PMID: 26635127 BACKGROUND

• Yap CYL, Taylor DM, Knott JC, Taylor SE, Phillips GA, Karro J, Chan EW, Kong DCM, Castle DJ. Intravenous midazolam-droperidol combination, droperidol or olanzapine monotherapy for methamphetamine-related acute agitation: subgroup analysis of a randomized controlled trial. Addiction. 2017 Jul;112(7):1262-1269. doi: 10.1111/add.13780. Epub 2017 Feb 28.

  PMID: 28160494 BACKGROUND

MeSH Terms

Conditions

Emergencies

Interventions

Olanzapine; Haloperidol; Diazepam

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Butyrophenones; Ketones; Organic Chemicals; Benzodiazepinones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: September 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

HK (1)