Parlak 2006.
Methods | RCT, parallel design | |
Participants |
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Interventions |
All groups given fentanyl citrate for preprocedural analgesia Aim: participant sedated to Ramsey Sedation Scale level 5 |
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Outcomes |
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Results |
< 65 years Midazolam vs < 65 years Propofol vs ≥65 years Midazolam vs ≥65 years Propofol
Unsure if satisfied: 0/12 vs 0/11 vs 2/25 vs 2/22 |
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Notes | Four groups for 2 drug comparisons divided by age group (< 65 years, ≥ 65 years) Anaesthetic administered by 2 final year medical residents from Emergency department and Anesthetic department |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratification by age and then computer software to generate random numbers |
Allocation concealment (selection bias) | Unclear risk | No details of how allocation was concealed |
Blinding of participants and personnel (performance bias) Major adverse events | High risk | Medical resident who administered anaesthetic aware of group allocation |
Blinding of participants and personnel (performance bias) Patient reported outcomes (recall/satisfaction) | High risk | Medical resident who administered anaesthetic aware of group allocation |
Blinding of participants and personnel (performance bias) Success of cardioversion | High risk | Medical resident who administered anaesthetic aware of group allocation |
Blinding of participants and personnel (performance bias) Minor adverse events | High risk | Medical resident who administered anaesthetic aware of group allocation |
Blinding of participants and personnel (performance bias) Time to induction etc/need for resedation. | High risk | Medical resident who administered anaesthetic aware of group allocation |
Blinding of outcome assessment (detection bias) Major adverse event | Low risk | Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm |
Blinding of outcome assessment (detection bias) Patient reported outcomes (recall/satisfaction) | Low risk | Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm |
Blinding of outcome assessment (detection bias) Success of cardioversion | Low risk | Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm |
Blinding of outcome assessment (detection bias) Minor adverse events | Low risk | Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm |
Blinding of outcome assessment (detection bias) Time to induction etc./need for resedation | Low risk | Researcher who collected data was blinded to participant treatment allocation. Blinding achieved by obscuring participant's arm |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Four participants excluded “because of difficulties in data collection”. Only 5% |
Selective reporting (reporting bias) | Unclear risk | All outcomes from methods section reported Prepublished protocol not sought |
Other bias | Low risk | Baseline characteristics largely comparable – given stratification by age |