Parlak 2006.
Methods | Stratified, randomized, blinded trial | |
Participants | 2 adult groups: 18‐65 years and ≥ 65 years old, requiring sedation for cardioversion | |
Interventions | Group 1: < 65 years: fentanyl 1 μg/kg IV, followed by midazolam 2 mg, then midazolam 1 mg every 2 minutes Group 2: < 65 years: fentanyl 1 μg/kg IV, followed by propofol 20 mg IV, then 20 mg every 2 minutes Group 3: ≥ 65 years: fentanyl 0.5 μg/kg IV, followed by midazolam 2 mg, then 1 mg every 2 minutes Group 4: ≥ 65 years: fentanyl 0.5 μg/kg, followed by propofol 20 mg IV, then 20 mg every 2 minutes |
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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: "randomization was achieved by first doing a stratification on age and then using computer software to generate random numbers" |
Allocation concealment (selection bias) | Low risk | Quote: "a study nurse obtained the randomization scheme from a computer and prepared the medications" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: data for 4 participants in propofol groups not collected (4/33) |
Other bias | Low risk | Comment: no obvious "other bias" identified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the researcher who collected the data was blinded to patient treatment allocation. Blinding was achieved by obscuring the patient's arm from the person collecting information" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: it is unclear whether the researcher who recorded the data was blinded to the outcome measures |