| Methods | Randomized controlled trial | |
| Participants | 1‐3 years, ASA I, minor plastic surgery Exclusion criteria: history of chronic illness, prematurity, developmental delay, previous surgery, parental insistence on a particular study group Recruitment: 60 children randomly assigned, 58 analysed (19 midazolam group, 20 PPIA group, 20 midazolam + PPIA group) Location: Japan | |
| Interventions | Midazolam group: midazolam 0.5 mg/kg PO premedication 40 minutes before induction PPIA group: parental presence (mother) at induction of anaesthesia Midazolam + PPIA group: both of the above All participants: sevoflurane induction in 100% oxygen, fentanyl 1 mcg/kg and vecuronium 0.1 mg/kg to facilitate tracheal intubation, sevoflurane maintenance 1.5%‐2.5% in 60% oxygen and fentanyl 4 mcg/kg | |
| Outcomes | Emergence behaviour assessed on the following 5‐point scale: 1 = obtunded with no response to stimulation 2 = asleep but responsive to movement or stimulation 3 = awake and responsive 4 = inconsolable crying 5 = thrashing behaviour requiring restraint Reported median (range) scores for emergence behaviour, not incidence of agitation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | computer‐generated random numbers |
| Allocation concealment (selection bias) | Unclear risk | method of allocation concealment not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | not viable to blind child and anaesthetist or to parental presence |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | outcome assessor blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 children excluded as a result of refusal to take oral midazolam (1 from midazolam group and 1 from midazolam + PPIA group) |
| Selective reporting (reporting bias) | Low risk | reported emergence behaviour scores |