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Randomized Controlled Trial Comparative Study
Premedication with melatonin vs midazolam: efficacy on anxiety and compliance in paediatric surgical patients.
- Pietro Impellizzeri, Enrica Vinci, Maria Cristina Gugliandolo, Francesca Cuzzocrea, Rosalba Larcan, Tiziana Russo, Maria Rosaria Gravina, Salvatore Arena, Gabriella D'Angelo, Eloisa Gitto, Angela Simona Montalto, Angela Alibrandi, Lucia Marseglia, and Carmelo Romeo.
- Unit of Pediatric Surgery, University of Messina, Messina, Italy.
- Eur. J. Pediatr. 2017 Jul 1; 176 (7): 947-953.
AbstractPreoperative anxiety is a major problem in paediatric surgical patients. Melatonin has been used as a premedicant agent and data regarding effectiveness are controversial. The primary outcome of this randomized clinical trial was to evaluate the effectiveness of oral melatonin premedication, in comparison to midazolam, in reducing preoperative anxiety in children undergoing elective surgery. As secondary outcome, compliance to intravenous induction anaesthesia was assessed. There were 80 children undergoing surgery randomly assigned, 40 per group, to receive oral midazolam (0.5 mg/kg, max 20 mg) or oral melatonin (0.5 mg/kg, max 20 mg). Trait anxiety of children and their mothers (State-Trait Anxiety Inventory) at admission, preoperative anxiety and during anaesthesia induction (Modified Yale Pre-operative Anxiety Scale), and children's compliance with anaesthesia induction (Induction Compliance Checklist) were all assessed. Children premedicated with melatonin and midazolam did not show significant differences in preoperative anxiety levels, either in the preoperative room or during anaesthesia induction. Moreover, compliance during anaesthesia induction was similar in both groups.
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