Pediatric anesthesia & critical care
Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA‐PAED): A protocol and statistical analysis plan for a randomized clinical trial
Study context
- Population
- Pediatric surgical patients aged 1–6 yearsplanned, randomised 1:1
- Participants
- 400 patients
- Planned comparison
- IV melatonin 0.15 mg/kg ≈30 min before end of surgery vs placebo
- Primary endpoint
- Incidence of emergence agitation (any Watcha score >2) during PACU stay
Methodological detailsdouble-blind, parallel two-arm, multicentre, superiority, Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) on days 1, 7 and 14; Serious Adverse Events (SAEs) assessed up to 30 days, Secondary outcomes: opioid consumption in post-anesthetic care unit (PACU) and adverse events
- Double-blind
- Parallel two-arm
- Multicentre
- Superiority
- PHBQ-AS on days 1, 7 and 14; SAEs assessed up to 30 days
- Secondary outcomes: opioid consumption in PACU and adverse events
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Intravenous MELAtonin for prevention of Postoperative Agitation and Emergence Delirium in children (MELA‐PAED): A protocol and statistical analysis plan for a randomized clinical trial. Acta Anaesthesiol Scand. Published 30 October 2023. doi:10.
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