Oral Olanzapine Versus Haloperidol or Diazepam

Phase 4

Terminated

• Conditions: Acute Agitation; Behavioural Emergency
• Interventions: Drug: Olanzapine oro-dispersible 5Mg Tab; Drug: Haloperidol 2Mg encapsulated Tab; Drug: Diazepam 2Mg encapsulated Tab

• Registration Number: NCT03246620
• Lead Sponsor: The University of Hong Kong

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-09-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	Olanzapine oro-dispersible 5Mg Tab	oro-dispersible tablet (wafer)(Zyprexa), 5 mg, single dose
Haloperidol	Haloperidol 2Mg encapsulated Tab	Haloperidol encapsulated tablet, 2 mg tablet, single dose
Diazepam	Diazepam 2Mg encapsulated Tab	Diazepam encapsulated tablet, 2mg tablet, single dose

Primary Outcome Measures

Name	Time	Method
Time to achieve adequate sedation	Within 60 minutes from drug administration	Adequate sedation is determined by a 6-point validated scale

Secondary Outcome Measures

Name	Time	Method
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	including airway management (jaw thrust, oral, nasal airway), need for assisted ventilation (bag/mask, intubation), oxygen desaturation \<90%, systolic BP\<90 mmHg, dystonic reactions, seizures, vomiting or aspiration

Trial Locations

Locations (1)

Queen Elizabeth Hospital; 🇭🇰 Hong Kong, Hong Kong