| Methods | Randomized controlled trial | |
| Participants | 1‐5 years, ASA I‐II, ambulant surgery for bilateral myringotomy Exclusion criteria: none stated Recruitment: 200 participants (50 in each of 4 groups) Location: USA | |
| Interventions | Group 1: halothane + IV ketorolac 1 mg/kg Group 2: halothane + IV saline placebo Group 3: sevoflurane + IV ketorolac 1 mg/kg Group 4: sevoflurane + IV saline placebo All participants: intranasal midazolam 0.2 mg/kg premedication, induction and maintenance with study anaesthetic agent with nitrous oxide | |
| Outcomes | EA defined as a score of 2 or 3 on the following 3‐point scale: 1 = asleep, calm, or mildly agitated but easily consolable 2 = moderately agitated or restless but inconsolable 3 = hysterical, crying inconsolably, or thrashing Other outcomes: vomiting, number of participants requiring rescue analgesia in PACU | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer‐generated random number code" |
| Allocation concealment (selection bias) | Low risk | "injections were prepared by the hospital pharmacist and placed in specially labelled syringes. Patients, physicians, and the research nurse were blinded to the syringes contents" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | as above |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | as above |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | no withdrawals |
| Selective reporting (reporting bias) | Low risk | reported incidence of EA |