Akil 2005.
Methods | Parallel‐group single‐centre randomized controlled trial conducted in Turkey | |
Participants | 53 children requiring micturating cystourethrogram with sedation (39 girls, 14 boys; mean age of 5.8 ± 3.5 years) | |
Interventions | Oral midazolam 0.6 mg/kg (max 15 mg) versus chloral hydrate 25 mg/kg (max 0.5 g) and placebo (saline) 15 ‐ 30 minutes before procedure | |
Outcomes |
Measured during procedures: Incomplete procedures Anxiety (measured during the procedure using Spielberger's Trait Anxiety Inventory) Participant co‐operation (measured during the procedure using Houpt behavioural scale; range 1 ‐ 6 with higher scores indicating better co‐operation) Tolerance of procedure (measured during the procedure using Frankl behaviour rating score; range 1 ‐ 4 with higher scores indicating better tolerance) Duration of sedation Onset of sedation Oversedation |
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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 | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes included in this review were not blinded ‐ only assessment of image quality was performed by a blinded outcome assessor |
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 |