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. 2019 Sep 3;2019(9):CD011749. doi: 10.1002/14651858.CD011749.pub2

Atalan 2013.

Methods RCT comparing the efficacy of haloperidol vs morphine for treatment of postoperative delirium
Study took place in a single ICU at a community hospital in Turkey
Participants Participants included 53 (N = 26 haloperidol, mean age 66.00 ± 8.39 years, 21/26 (80.8%) male; N = 27 morphine, mean age 65.74 ± 9.67 years, 18/27 (66.7%) male) patients who underwent cardiac surgery, with or without cardiopulmonary bypass, and were diagnosed with hyperactive delirium using the CAM‐ICU and RASS (to determine subtype)
Study enrolment between January 2010 and July 2012
Interventions Participants received 5 mg haloperidol or 5 mg morphine sulphate intramuscularly every hour until adequate sedation (RASS ‐1 to + 1) was achieved. Participants who were still agitated despite administration of 20 mg/d morphine or 20 mg/d haloperidol received 2.5 mg lorazepam orally, twice daily
Assessment: delirium status (CAM‐ICU) was determined every 12 hours until discharge from hospital or for a maximum of 10 days following surgery. Participants were considered delirium‐free after a period of 24 hours without symptoms
Non‐drug strategies: not reported
Outcomes Primary (measured at completion of study drug)
  1. Duration of delirium


Secondary (measured at completion of study drug)
  1. Duration of delirium

  2. Total daily medication doses

  3. Need for additional sedative drug

  4. RASS scores

  5. Percentage of patients maintaining target RASS score

  6. Incidence of re‐intubation

  7. Repeat surgery and ICU re‐admission

  8. Length of ICU and hospital stay

  9. Hospital mortality rate

Notes Funding
  1. The funding source for this study was not mentioned


Registration
  1. No trial registration number was identified

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The manuscript stated that participants were randomized to 2 groups but provided no specific details on the method used
Allocation concealment (selection bias) Unclear risk No details were provided on the method of randomization or concealment used. Attempts to obtain details from study authors were not successful
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No details were provided on the method of drug preparation and dispensing used. Attemtps to obtain details from study authors were not successful
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Abnormal or delirious behaviour was recorded by the bedside nurse and reviewed by the research team. Clinical evaluation was performed by the intensivist and the consulting psychiatrist, who were blinded to study group assignment
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No flow chart was included to report the numbers of screened vs randomized participants
Selective reporting (reporting bias) Unclear risk All outcomes reported in methods were included in results. Data presented for all participants were included in the analysis. However without a published protocol or trial registration, it is unknown if all outcomes were reported as planned
Other bias Unclear risk The funding source for the study was not mentioned
All participants were permitted rescue lorazepam
Sample size calculation was not provided