Fukata 2014.

Methods	Design: Randomised open‐label trial of postoperative low dose intravenous haloperidol in older patients undergoing abdominal, orthopaedic or other surgery Date of study: January 2007 ‐ December 2012 Power calculation: Yes Frequency of outcomes assessment: Daily from postoperative day 0 to day 7 Inclusion criteria: 75 years or older; elective abdominal surgery under general anaesthesia or elective orthopaedic surgery under general or spinal anaesthesia and who could consent to participate Exclusion criteria: Emergency surgery; preoperative NEECHAM score < 20; periodic dosing with newly added or switched antipsychotics, antidepressants, hypnotics or anti‐Parkinson agents within 2 weeks prior to surgery; previous treatment with haloperidol for delirium after surgery before the initiation of postoperative preventive haloperidol administration.
Participants	Number in study: 121 Country: Japan Setting: General and orthopaedic surgery units in five co‐operative hospitals Age: Mean age 80.5 years (SD 0.5) in intervention group versus 80.2 (SD 0.5) for controls Sex: Males: Intervention 32/59; Control: 32/62 Co‐morbidity: Abdominal surgery in 52 intervention and 55 controls; orthopaedic surgery in 5 intervention and 4 control; and other surgery in 2 intervention and 3 control patients; No differences in urinary incontinence, past history of excitement/hyperkinesia; or use of oral psychotropics Dementia: Not specifically assessed. MMSE score (mean (SD) in intervention = 23.3 (0.7) and 23.0 (0.7) in control patients
Interventions	Intervention: 2.5 mg/day of intravenous haloperidol dissolved in 100 mL of saline for first 3 days after surgery. Administered by infusion at 6 pm. Control: Usual care
Outcomes	1. Delirium incidence using NEECHAM 2. Delirium incidence stratified by low MMSE score (data not fully reported in paper) 3. Delirium severity using NEECHAM (data not fully reported in paper) 4. Delirium duration (data not fully reported in paper) 5. Adverse events (data not fully reported in paper)
Notes	Funding source: Research Grant for Longevity Sciences (17C‐3, 21‐13) from the Ministry of Health, Labour and Welfare and The Research Funding for Longevity Sciences (23‐28) from the National Center for Geriatrics and Gerontology (NCGG), Japan Declaration of interest: The authors declare 'no conflicts of interest' Delirium not fully excluded at enrolment ‐ excluded if NEECHAM < 20 but this may not exclude all delirium Haloperidol given one day postoperatively rather than preoperatively or immediately postoperatively as in other studies, and prevalent delirium not excluded. Inclusion criteria only mention abdominal and orthopaedic surgery but results presented for 5 patients who underwent ‘other’ including vascular surgery.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	Method not described
Random sequence generation (selection bias)	Low risk	Computer‐generated allocation, adjusted for age, gender and department
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel unblinded to allocation; control group did not receive any IV medication/placebo
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label study; delirium assessment unblinded to allocation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Data reported on 119/121 patients. 2 patients in control group received haloperidol for delirium on day of surgery, therefore withdrawn
Selective reporting (reporting bias)	Unclear risk	Insufficient information to assess
Other bias	Low risk	No evidence of other bias