NCT03021486.

Trial name or title	Haloperidol and/or chlorpromazine for refractory agitated delirium
Methods	Randomised controlled trial
Participants	54 participants with advanced cancer admitted to an acute palliative care unit. Delirium according to DSM‐V criteria for hyperactive or mixed delirium with Richmond Agitation‐Sedation Scale (RASS) ≥ 1 in the past 24 hours
Interventions	All participants receive haloperidol 2 mg intravenously every 6 hours regularly and every hour as needed upon admission to acute palliative care unit (APCU). If RASS scores reach ≥ +2, participant randomised Group1: haloperidol only ‒ haloperidol 2 mg intravenously every 4 hours and every hour as needed Group 2: chlorpromazine only ‒ chlorpromazine 25 mg intravenously every 4 hours and every hour as needed Group 3: haloperidol and chlorpromazine ‒ haloperidol 1 mg intravenously every 4 hours and every hour as needed
Outcomes	Primary outcome: Agitation intensity in participants admitted to an acute palliative care unit who did not experience a response to low‐dose haloperidol (time frame: 24 hours). Agitation intensity is being measured by Richmond Agitation‐Sedation Scale (RASS)
Starting date	5 June 2017 Estimated study completion date: June 2021
Contact information	Responsible Party: M.D. Anderson Cancer Center Principal Investigator: Dr David Hui. Email: dhui@mdanderson.org ClinicalTrials.gov identifier: NCT03021486
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