44
Participants
Start Date
June 1, 2021
Primary Completion Date
June 1, 2023
Study Completion Date
September 1, 2024
oral melatonin
Melatonin treated children receive a single dose of oral melatonin 0.5 mg/kg (for a max 10 mg) in a fixed volume of 5 mL of water , 1 hour before induction of anesthesia for surgery
Placebo
Children in the Control group receive 5 ml of 5% dextrose solution once 1 hour before induction of anesthesia
Neonatology Unit, Department of Medicine and Surgery, University of Parma, Pietro Barilla Children's Hospital, Parma
University Hospital of Messina, Italy, Messina
University of Messina
OTHER
University of Florida
OTHER
University of Siena
OTHER
"University of Urbino Carlo Bo"
OTHER
University of Parma
OTHER