Background: Simple fractures and joint dislocations recruited for this study are among the painful procedures managed in the Emergency Room setting in children. Successful management requires adequate sedation for the relief of anxiety and analgesia for pain relief.

Aim: To compare the sedative and analgesic effects of fentanyl/midazolam (F/M) and ketamine/midazolam (K/M) combination during paediatric day-case orthopaedic procedures.

Methodology: A prospective randomized double-blind trial that involved 70 paediatric patients aged 5-12 years requiring orthopaedic procedures. The patients were randomized into two groups of 35 each. The F/M group received an intravenous (IV) bolus of fentanyl 0.5 μg/kg while the K/M group received an IV bolus of ketamine 0.5 mg/kg. The outcomes were procedural distress and anxiety from the Observational Scale of Behavioural Distress revised (OSBD-r) score, depth of sedation during and up to 120 minutes after the procedure using the Ramsay Sedation Scale (RSS), and pre-sedation and post-procedure pain scores up to 120 minutes after the procedure according to the Wong-Baker Faces Pain Scale (WBFPS) for children within the age range of 5-7 years and the Numerical Rating Scale (NRS) for children within the age range of 8-12 years.

Results: The proportion of children with severe pain was 75.3% in the F/M group compared with 68.6% in the K/M group, which occurred at baseline. Depth of sedation at baseline, every 5 minutes up to 25 minutes during the procedure and at 60 and 90 minutes post-procedure was similar. However, a significant difference was found at 30 minutes post-procedure: 12 (34.3%) K/M subjects achieved an RSS score of 1 compared to 3 (8.6%) in the F/M group, while 32 (91.4%) in the F/M group achieved an RSS of 2 compared to 21 (60.0%) among K/M subjects. During the procedure, there was a significantly lower level of OSBD-r score among K/M subjects compared with F/M subjects. No statistically significant differences were found in WBFPS and NRS scores.

Conclusion: K/M achieved better sedation and pain relief than F/M.