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

Holger 2005.

Methods Prospective randomized trial
Participants Convenience sample of adults 18‐65 years, requiring sedation for painful procedures
Interventions Propofol (0.5 mg/kg IV) with boluses (0.25 mg/kg IV) every 30‐45 seconds until minimum sedation score reached. Additional boluses as required to maintain sedation
Midazolam (1 mg IV) followed by 1 mg every 2 minutes until minimum sedation score reached. Additional boluses as required to maintain sedation level
Outcomes Primary outcome measure was nurse monitoring time
Other outcome measures were:

  • adverse events

  • maximum sedation score using RSS

  • satisfaction using VAS satisfaction score

  • 24‐hour recall

  • complications at 24 hours
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no details provided regarding method of randomization
Quote: "patients were randomized to either the propofol or the midazolam group"
Allocation concealment (selection bias) Unclear risk Comment: no details provided regarding allocation of group assignment
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "eight patients failed to reach an RSS of 3 and were excluded. seven of these 8 were assigned to the midazolam group, 1 to the propofol group"
Comment: this represents 20% of the total number of participants excluded from analysis due to inadequate sedation (7/8 from 1 group), thus biasing outcome data. While it is acknowledged in the results section ‐ quote: "the majority of physicians stated frustration with waiting for an RSS of 3 to occur as reason to drop the patient from the study", it represents a significant loss of data and source of bias
Other bias Low risk Comment: no obvious "other bias" identified
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: only participants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "neither the RN nor the physician was blinded to the randomized drug"
Comment: this is significant as subjective assessment scales were used as measure of outcome ‐ RSS and VAS