Miner 2007.
Methods | Randomized, non‐blinded prospective trial | |
Participants | Adults > 18 years old requiring procedural sedation | |
Interventions | Propofol 1 mg/kg bolus, followed by 0.5 mg/kg every 3 minutes as needed Etomidate 0.1 mg/kg, followed by 0.05 mg/kg every 3‐5 minutes as needed |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "using computer generated random numbers by the investigators" |
Allocation concealment (selection bias) | Low risk | Quote: "selecting a sequentially numbered sealed envelope containing the group assignment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants who received study drugs were analysed. 109/110 allocated to propofol received the drug. 105/110 allocated to etomidate received the drug |
Other bias | Low risk | Comment: no obvious "other bias" identified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "we were unable to blind patients, physicians, or data collectors to the agent used in each procedural sedation" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: it is unclear whether assessors were blinded to outcome measurements. Some measurements were recorded by research assistants who may not have been aware of outcome measures but some were documented by the physicians who ‐ quote: "were likely to have preconceived notions about the 2 agents". Some outcome measures came from the participants themselves, who may have been unaware of the outcomes |