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. 2015 Jul 29;2015(7):CD007399. doi: 10.1002/14651858.CD007399.pub2

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
Outcomes
  • Level of sedation (modified RSS)

  • Participant reactions to cardioversion (recorded using subjective scale)

  • Participant satisfaction (questionnaire including Likert‐type questions)

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