Intravenous melatonin for prevention of emergence delirium in children
Project Status:
Recruiting
Background
Emergence delirium is a common challenge when children have been under general anaesthesia. Symptoms range from averted eye gaze to non-purposeful movements and inconsolable crying. In addition to the discomfort caused for the child, the condition can be cause for parental concern and prolong the postoperative recovery.
The aim of the MELA-PAED trial is to investigate whether intravenous melatonin administered during anesthesia can prevent emergence delirium in preschool-aged children.
Intervention
400 children aged 1-6 years will be randomized 1:1 to
A
0.15 mg/kg intravenous melatonin 1 mg/ml
B
A corresponding volume of placebo (sodium chloride 9 mg/ml)
Study Design
The MELA-PAED trial is a randomized, double-blinded, placebo-controlled multi-center trial. Participants will receive the intervention approximately 30 minutes before the end of their procedure. They will be monitored in the post-anesthetic care unit until discharge and a follow-up questionnaire will be performed on days 1, 7, and 14. Hospitalization or other Serious Adverse Events will be monitored up top 30 days after the intervention.
The primary outcome, emergence agitation, will be assessed on the Watcha scale during admission in the post-anesthetic care unit. Secondary outcomes are postoperative opioid use and adverse events.