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 |
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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 |
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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 |
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Outcomes |
Primary (measured at completion of study drug)
Secondary (measured at completion of study drug)
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Notes |
Funding
Registration
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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 |