Hollenhorst 2001.
Methods | Single‐centre parallel‐group randomized controlled trial conducted in Germany | |
Participants | 54 participants aged 18 to 65 years old scheduled for magnetic resonance imaging (MRI) for the first time (mean age: 43 ± 14.6 years in the midazolam group and 49 ± 11.7 years in the placebo group; 48% men in midazolam group and 37% men in placebo group) | |
Interventions | 1) Intranasal midazolam 4 mg 2) placebo |
|
Outcomes | 1) Level of sedation measured 15 minutes after medication and after MRI. Participant sedation was evaluated by 1of the authors using a 5‐point sedation scale (1 = agitated, non co‐operative; 2 = alert, restless; 3 = calm, eyes spontaneously open; 4 = drowsy, responds to minor stimulation; 5 = asleep, rousable but does not respond to minor stimulation) 2) Numerical rating of anxiety measured 15 minutes after medication and after MRI. Visual Analogue Scale of Anxiety comprised an undivided 100‐mm line, with 0 meaning “I am not anxious at all,” and 100 meaning “I am extremely anxious.” Participants were instructed to mark 1 point on the line that corresponded to the intensity of their anxiety at that moment 3) Incomplete procedures |
|
Notes | Conflicts of interest or funding sources were not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information about blinding of assessor of sedation level. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | No clear evidence that measured outcomes were not reported (trial protocols were not sought for confirmation) |
Other bias | Low risk | None expected |