Knott 2006.
Methods | Allocation: randomised. Blinding: double‐blind. Duration: 2 hours. Settings: conducted in the ED of a large Australian metropolitan university hospital. |
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Participants | Diagnosis: marked agitation, required chemical restraint (about 66% 'mental illness'). N = 170. Age: range 18 to 65 years. Sex: unspecified. History: aged judged to be 18 to 65 years (inclusive), exhibited marked agitation that required chemical restraint (decision of consultant (attending) emergency physician or a senior accredited resident of the Australasian College for Emergency Medicine). Excluded: people with known hypersensitivity to either drug, known pregnancy or readily reversible causes for the agitation (systolic blood pressure < 90 mmHg, hypoxia, hypoglycaemia). If treating physician believed agitation was due to acute alcohol withdrawal, participant excluded because this condition is particularly amenable to treatment with benzodiazepines. |
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Interventions | 1. Droperidol5 mg IV. N = 86. 2. Midazolam5 mg IV. N = 84. |
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Outcomes | Global state: time to sedation, need for subsequent sedation within 60 minutes of initial (adequate) sedation. Adverse effects: ECG, corrected QT (QTc) interval on a 12‐lead ECG. Physiological: pulse rate, blood pressure, oxygen saturation. Loss to follow‐up. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was determined from random‐number tables". Response: randomisation probably done. |
Allocation concealment (selection bias) | Low risk | Quote: "These solutions were packaged in identical vials and randomly assigned to serially numbered study packs". Response: low risk of selection bias. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "patients and staff remained blinded to which drug was used throughout each patient’s stay". Response: blinding probably practiced. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "and the codes remained with pharmacy until the study was complete". Response: blinding of the outcome assessment probably done. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "One hundred seventy patients were enrolled by study‐pack allocation. Of these, 17 packs were lost so that data on 153 patients were available for analysis". Response: 17 study packs were lost. It is unknown whether these were selected and discarded unused or used for sedation, with all documentation subsequently lost. |