Ab‐Rahman 2010.
Methods | Randomized single‐blind control trial | |
Participants | "Adult patients who presented to the ED for either brief or intensely painful procedures, having marked anxiety or requiring some degree of immobilization" | |
Interventions | Group A: IV fentanyl 1 μg/kg as a titration dose and propofol 1 mg/kg followed by propofol 0.5 mg/kg if needed Group B: IV fentanyl 1 μg/kg as a bolus dose and a titration dose of midazolam 0.1 mg/kg followed by midazolam 0.1 mg/kg if needed |
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Outcomes | Level of sedation, vital signs, cardiorespiratory adverse effects | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "all 40 patients were selected by convenience sampling, and further randomization into two groups was carried out by using the computer‐generated random permuted blocks of four patients" |
Allocation concealment (selection bias) | Unclear risk | No information to permit judgement of 'low risk' or 'high risk' |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were 70 study participants in a published abstract of the study, but only 40 study participants in the final published study |
Other bias | Low risk | Comment: no obvious "other bias" identified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the drugs were single blinded. They were supplied by the pharmacy department, wrapped individually and placed in an envelope. Each envelope was sealed and labelled accordingly as drug A or B. The operators, emergency physicians and residents in Emergency Medicine, including the main researcher, were unaware of the exact drug to be given until the envelope was opened" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information to permit judgement of 'low risk' or 'high risk' |