Calver 2015.
Methods | Allocation: randomised. Blindness: double. Duration: 2 hours. |
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Participants | Diagnosis: mental illness (N = 114), drug‐induced psychosis (N = 70), intoxication (N = 17), threatened self‐harm (N = 6), other/unknown (N = 19) (p.225)*. N = 228. Age: major than 18 years. Sex: 144 males, 84 females. History: admitted involuntarily to the psychiatric intensive care unit from the psychiatric emergency care centre (p.223). Excluded: patients willing to take oral medication for sedation without physical restraint or seclusion. Setting: psychiatry intensive care unit. |
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Interventions | 1. Haloperidol: fixed dose 10 mg/IM. N = 110. 2. Droperidol: fixed dose 10 mg/IM. N = 118. |
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Outcomes | Tranquillisation or asleep, time to sedation. Need for additional benzodiazepines. Adverse events: respiratory rate less than 12 breaths/min, systolic blood pressure less than 90 mmHg, heart rate less than 60 bpm, oxygen saturation less than 90% or the presence of extrapyramidal side effects. |
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Notes | *when available, outcomes are reported for the mental illness sub‐group; gently provided by the authors (contacted 5th July 2016). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Block randomisation was used. Microsoft Excel was used to randomly create blocks of four (ABAB, AABB, etc.) or six (ABABAB, AAABBB, etc.)" (p.224). |
Allocation concealment (selection bias) | Low risk | "Pre‐packed treatment kits [...] contained either droperidol (10mg in 2ml) or haloperidol (10mg in 2ml) [...] transferred into vials identical" (p.224). |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind study. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "labels A or B and not the drug names were known to the investigator. This investigator analysed the data independently and presented this to the other investigators" (p.224). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No evidence of incomplete outcome data. |
Selective reporting (reporting bias) | Unclear risk | "In breach of the study protocol midazolam was given nine times simultaneously with the study drug" (p.226); no further evidence of selective reporting. |
Other bias | High risk | Short study. |