NCT03743649.

Trial name or title	Haloperidol and lorazepam in controlling symptoms of persistent agitated delirium in patients with advanced cancer undergoing palliative care
Methods	Randomised controlled trial
Participants	206 participants with advanced cancer admitted to an acute palliative care unit With hyperactive or mixed delirium with RASS ≥ 1 in the past 24 hours despite efforts to treat potential underlying cause
Interventions	Group 1: participants receive haloperidol IV over 3 to 15 minutes every 4 hours and as needed and placebo IV every 4 hours and as needed until discharge from palliative care unit. Group 2: participants receive lorazepam IV over 3 to 15 minutes every 4 hours and as needed and placebo IV every 4 hours and as needed until discharge from palliative care unit. Group 3: participants receive haloperidol IV over 3 to 15 minutes every 4 hours and as needed and lorazepam IV over 3 to 15 minutes every 4 hours and as needed until discharge from palliative care unit Group 4: patients receive placebo IV every 4 hours and lorazepam IV over 3 to 15 minutes as needed until discharge from palliative care unit.
Outcomes	Primary outcome: Change in Richmond Agitation Sedation Scale (RASS) score in patients admitted to an acute palliative care unit (time frame: baseline to 24 hours) Secondary outcomes: Rescue medication use at 24 hours Proportion of patients in the target RASS range (defined as RASS between −2 and 0) as well as the proportion of patients achieving treatment response (defined as RASS reduction of ≥ 1.5 points) at 24 hours Perceived comfort as assessed by caregivers and bedside nurses at 24 hours Proxy comfort goal up to 24 hours Symptom expression assessed using Edmonton Symptom Assessment Scale at 24 hours Delirium severity assessed using Memorial Delirium Assessment Scale at 24 hours Incidence of adverse events up to 24 hours Quality of end‐of‐life care at 24 hours Novel predictive markers of response up to 24 hours
Starting date	31 May 2019
Contact information	Responsible Party: M.D. Anderson Cancer Center Chief Investigator: Dr David Hui. Email: dhui@mdanderson.org ClinicalTrials.gov identifier: NCT03743649
Notes

DSM‐IV‐TR: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
 DSM‐V: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
 IV: intravenously
 mg: milligram
 N: sample size