Discussion
delirium, Delirium
SECONDARY, RECRUITMENT
Here we report the first multicentre, randomised trial of melatonin The magnitude of difference in adjusted mYPAS-SF observed in the midazolam group compared with melatonin was a consistent finding throughout all three time points (transfer, entry into anaesthetic room, and anaesthetic induction). Consequently, both ITT and PP analyses delivered 95% CI heavily skewed in favour of midazolam (The MAGIC trial gathered a number of secondary outcomes to assist with triangulation of those properties of a favourable premedication that may not be directly linked to anxiolytic efficacy. Regarding all secondary outcome measures, our findings are underpowered and so care should be taken with their interpretation. Midazolam’s clinical profile led to a pre-trial assumption that postoperative recovery would be more impaired in comparison to the melatonin group, although trial measures of sedation recovery (VSRS) and emergence delirium (PAED index) demonstrated no such difference between groups (Mean post-surgery PAED and VSRS scores (with 95% CI) by treatment group. CI, confidence interval; PAED, Paediatric Anaesthesia Emergence Delirium scale; VSRS, Vancouver Sedation Recovery Scale.A number of barriers to recruitment were noted during a formal qualitative analysis, undertaken as part of the internal pilot of the trial