| Methods | Randomized controlled trial | |
| Participants | 1‐6 years, ASA I, minor surgery below umbilicus (inguinal hernia repair, undescended testis, hypospadias, circumcision) Exclusion criteria: neurological or psychiatric disease, attention deficit disorder, emergency procedure, medical contraindication to performance of caudal block or a previous anaesthesia experience, caudal block judged inadequate (heart rate and/or blood pressure increase > 10% baseline on skin incision, mCHEOPS pain score > 4 in recovery room) Recruitment: 70 children randomly assigned, 67 analysed (34 ondansetron, 33 control) Location: Turkey | |
| Interventions | Ondansetron 0.1 mg/kg IV up to maximum of 4 mg Control group: placebo All participants: premedication with rectal midazolam 0.5 mg/kg 30 minutes previously, sevoflurane 8% induction with 50% nitrous oxide in oxygen, LMA insertion, randomization to ondansetron or placebo, caudal block 0.8 mL/kg 0.25% levobupivacaine with skin incision 15 minutes after block completed, maintenance with sevoflurane 1%‐2% (corrected for stable intraoperative haemodynamics) in 60:40 nitrous oxide/oxygen mixture, awake LMA removal | |
| Outcomes | EA defined as score > 5 on 10‐point scale (TPS) ranging from 1 (calm or asleep) to 10 (worst possible and inconsolable agitation). TPS assessed every 10 minutes for first 30 minutes in recovery room Other outcomes: mYPAS preoperative anxiety scores, mCHEOPS pain scores in recovery, time to eye opening, time to discharge readiness, vomiting | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomisation was performed immediately before anaesthetic induction by drawing prepared numbers from closed envelopes" |
| Allocation concealment (selection bias) | Low risk | "closed envelopes" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | child blinded, not stated whether anaesthetist blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "independent observer blinded to group assignment" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 exclusions: 1 from each group for inadequate caudal block intraoperatively (received fentanyl following skin incision), and 1 exclusion from placebo group for mCHEOPS pain score > 4 in PACU |
| Selective reporting (reporting bias) | Low risk | reported incidence of EA |