Methods | Randomized controlled trial | |
Participants | 2‐11 years, ASA I‐II, otorhinolaryngological procedures Exclusion criteria: known allergy to study drugs, sleep apnoea, developmental delay, psychological disorders Recruitment: 186 children randomly assigned, 176 analysed (89 sevoflurane, 87 propofol) Location: Japan | |
Interventions | Control group: sevoflurane induction and maintenance Intervention group: propofol induction and maintenance | |
Outcomes | EA defined as a score of 3 or 4 on following 4‐point scale: 1 = calm, 2 = not calm but could easily be consoled 3 = not easily calmed, moderately agitated or restless 4 = combative, excited or disoriented Other outcomes: emergence time, time in PACU, haemodynamics, PONV, laryngospasm, preschool versus school‐aged incidence of EA | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned," method of random sequence generation not stated |
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, anaesthetist not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "during the recovery period, an independent anesthesiologist, who was blinded to the anaesthetic used, recorded all the observations and measurements" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 children excluded because of insufficient analgesia (6 propofol, 4 sevoflurane) |
Selective reporting (reporting bias) | Low risk | reported incidence of EA |