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

Bakri 2015.

Methods RCT comparing the efficacy of dexmedetomidine, ondansetron, and haloperidol for treatment of postoperative delirium
Study took place in a single 24‐bed ICU (mixed medical and surgical) in Saudi Arabia
Participants Participants included 96 (N = 32 dexmedetomidine, mean age 31 ± 4 years, 29/32 (91% male); N = 32 ondansetron, mean age 32 ± 5 years, 30/32 (94%) male, N = 32 haloperidol, mean age 30 ± 7 years, 28/32 (88%) male) critically ill trauma patients diagnosed with postoperative delirium (ICDSC score ≥ 4)
Study enrolment between 2011 and 2013
Interventions Participants received 1 μg/kg dexmedetomidine, 4 mg ondansetron, or 5 mg haloperidol, administered as a continuous intravenous infusion over 20 minutes. Study drug was started after delirium was diagnosed and was given twice daily for 3 consecutive days
Treating physicians were allowed to prescribe rescue haloperidol for all groups
Assessment: ICDSC was administered twice daily
Non‐drug strategies: not reported
Outcomes Primary outcome (measured day 3)
  1. Number of patients with delirium


Secondary outcomes (measured day 3)
  1. Number of patients requiring rescue haloperidol

  2. Mean dose of rescue haloperidol

Notes Funding
  1. The study was carried out without external funding


Registration
  1. No trial registration number was included in the manuscript

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomly allocated to 3 equal groups according to a computer‐generated random numbers sequence
Allocation concealment (selection bias) Unclear risk Method of concealment was not reported and was not available from study authors
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Study medications were prepared by physicians who were not part of the research team. All study drug was administered as a continuous infusion over a 20‐minute period to maintain blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Data were collected by researchers blinded to study allocation. Participants were managed by ICU staff not included in the study. ICU nurses conducted delirium assessments as part of the standard of care
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No flow chart was included to report 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 All participants were permitted rescue haloperidol. Use of rescue haloperidol was an outcome
Sample size calculation was not reported