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Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

An open-label clinical trial of oral transmucosal haloperidol and oral transmucosal olanzapine in the treatment of terminal delirium at home

Authors: Xiao-Juan Lyu, Adrian David Kan, Poh-Heng Chong, Keegan Lin, Yung-Hua Koh, Zhi-Zheng Yeo

Published in: Trials | Issue 1/2022

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Abstract

Background

The phenomenon of restlessness, agitation, or cognitive disturbances experienced by dying patients is well-known in palliative care; more than half of these patients will experience delirium symptoms at end-of-life. When not identified early and effectively managed, delirium symptoms could lead to caregiver and patient distress and harm.

Methods

Eighty patients with a prognosis of 7 days or less will be recruited for an open-label randomised control trial. The two arms compare oral-transmucosal haloperidol 2.5 mg vs olanzapine 5 mg over 72 h. The severity of agitation, delirium and toxicities of treatments will be compared at the 24th, 48th and 72nd hour after drug administration.

Discussion

This trial is the first to compare anti-psychotics in the management of delirium at the dying stage in the home hospice setting using the oral transmucosal route. Ethical considerations, as well as recruitment procedures, are discussed.

Trial registration

This study was registered in ClinicalTrials.​gov – identifier NCT04750395
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Metadata
Title
An open-label clinical trial of oral transmucosal haloperidol and oral transmucosal olanzapine in the treatment of terminal delirium at home
Authors
Xiao-Juan Lyu
Adrian David Kan
Poh-Heng Chong
Keegan Lin
Yung-Hua Koh
Zhi-Zheng Yeo
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06238-4

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