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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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 : 80 patients with a prognosis of 3 days or less will be recruited for an open-label randomized control trial. The two arms compare oral-transmucosal haloperidol 2.5mg vs olanzapine 5mg over 72 hours. The severity of agitation, delirium and toxicities of treatments will be compared at the 24 th , 48 th and 72 nd 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 : ClinicalTrials.gov, NCT04750395. Registered 11 February 2021, https://clinicaltrials.gov/ct2/show/NCT04750395