| Methods | Randomized controlled trial | |
| Participants | 18 months‐10 years, ASA I‐II, MRI scans Exclusion criteria: midazolam premedication, neurological condition limiting communication, defined psychological/emotional disorder, cognitive delay Recruitment: 32 participants (16 intervention, 16 control) Location: USA | |
| Interventions | Intervention group: fentanyl 1 mcg/kg IV 10 minutes before end of anaesthesia Control group: saline IV 10 minutes before end of anaesthesia All participants: sevoflurane induction with nitrous oxide, sevoflurane maintenance in 100% oxygen | |
| Outcomes | EA defined as a score ≥ 4 for ≥ 5 minutes despite all calming efforts by the child's parents/guardians and nursing personnel using 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 = crying 5 = thrashing behaviour that requires restraint Other outcomes: duration of anaesthesia, duration of agitation, itching or vomiting, time to hospital discharge | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer‐generated random number assignment" |
| Allocation concealment (selection bias) | Unclear risk | method of allocation concealment not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | child blinded, not stated whether treating anaesthetist was blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "one trained observer, blinded to patient group assignment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | no withdrawals |
| Selective reporting (reporting bias) | Low risk | reported incidence of EA |