Calver 2015.
Methods | Allocation: randomised. Blinding: 'masked study'. Duration: 120 minutes. Settings: psychiatric intensive care unit of a large tertiary specialist mental health facility, Australia. |
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Participants | Diagnosis: people with agitation or aggression admitted involuntarily to psychiatric intensive care unit from the psychiatric emergency care centre. N = 228. Age: ≥ 18 years. Sex: men and women. History: adults (> 18 years of age) with acute behavioural disturbance requiring parenteral medication for sedation and in whom verbal de‐escalation or oral medication (or both) had failed. Excluded: people < 18 years old and willing to take oral medication for sedation without physical restraint or seclusion. |
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Interventions | 1. Droperidol 10 mg IM. N = 118. 2. Haloperidol 10 mg IM. N = 110. |
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Outcomes | Global state: time to sedation, failed sedation, use of additional sedation, successful sedation. Adverse drug effects. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Block randomisation was used". Response: randomisation probably done. |
Allocation concealment (selection bias) | Low risk | Quote: "Microsoft Excel was used to randomly create blocks of four (ABAB, AABB, etc.) or six (ABABAB, AAABBB, etc.). The use of different block sizes meant that it was impossible to predict the next treatment". Response: allocation concealment done. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The list of study codes with allocations was generated by a research assistant and supplied to the Calvary Mater Newcastle pharmacy, so that the investigators and treating staff remained unaware of the allocations". Response: both participants and personnel were blind to the allocations. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The pharmacy re labelled the vials of haloperidol or droperidol with study numbers based on the list of allocations". Response: blinding of outcome assessment done. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "There were 584 sedation episodes during the 23‐month study period and of these 356 were not included in the analysis because the treating clinician elected to give labelled parenteral sedation... an initial SAT score was recorded which was similar to those of the study participants". Response: participants initially recruited were included in the final analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Low risk |