| Methods | Randomized placebo‐controlled trial | |
| Participants | 6 months‐8 years, MRI scans Exclusion criteria: haemodynamic/respiratory unstable participants, severe mental retardation/physical disabilities, sedative/anticonvulsant treatment, emergency MRI scans, extremely distressed/uncooperative children, parental refusal Recruitment: 90 participants (28 control, 33 group K, 29 group N) Location: Canada | |
| Interventions | Group K: ketamine 0.25 mg/kg IV at end of procedure Group N: nalbuphine 0.1 mg/kg IV at end of procedure Control group: saline at end of procedure All participants: sevoflurane induction in 100% oxygen, sevoflurane maintenance in air/oxygen, 10 mL/kg Ringer's solution followed by maintenance, LMA | |
| 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 | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "random list was established by the department of Epidemiology and Human Statistics of our institution" |
| Allocation concealment (selection bias) | Low risk | "The vials used for the study were prepared by the pharmacy of our institution. All vials were identical and contained the same volume of transparent and unidentifiable fluid. The patient's anesthesiologist and the nursing staff were unaware of the drug administered" |
| 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 |