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. 2016 Dec 15;2016(12):CD002830. doi: 10.1002/14651858.CD002830.pub3

Knott 2006.

Methods Allocation: randomised.
Blinding: double‐blind.
Duration: 2 hours.
Settings: conducted in the ED of a large Australian metropolitan university hospital.
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.
Interventions 1. Droperidol5 mg IV. N = 86.
2. Midazolam5 mg IV. N = 84.
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.
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.