| Methods | Randomized controlled trial | |
| Participants | 1‐7 years, ASA I‐II, infraumbilical day case surgery Exclusion criteria: allergy to study drugs, psychological or emotional disorders, developmental delay, contraindication to caudal block, caudal block failure (heart rate increase at skin incision) Recruitment: 95 children randomly assigned, 84 analysed (42 in each group) Location: Turkey | |
| Interventions | Group MH: midazolam 0.5 mg/kg and hydroxyzine 1 mg/kg oral premedication 30 minutes before Group M: midazolam 0.5 mg/kg oral premedication 30 minutes before All participants: no parental presence at induction, induction with sevoflurane 7% with nitrous oxide 60% in oxygen, maintenance sevoflurane 2% with 60% nitrous oxide, IV alfentanil 10 mcg/kg, LMA, caudal block 0.25% bupivacaine (0.8 mL/kg up to 16 mL), parental presence in PACU | |
| Outcomes | PAED scale score assessed every 5 minutes for first 30 minutes in PACU EA defined as PAED score ≥ 16 at any time during the 30‐minute follow‐up period Median PAED scores for each group also reported Other outcomes: parental separation score, induction quality, sedation quality (before induction), Ramsay sedation score at 30 minutes in PACU, pain scores in PACU (CHIPPS) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomisation and allocation....was performed using computerised numbers" |
| 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 blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | outcome assessor blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 withdrawals from group M (5 did not take premedication, 2 delayed transfer to operating room) and 4 from group MH (3 did not take premedication, 1 had caudal block failure) |
| Selective reporting (reporting bias) | Low risk | reported incidence of EA |