Atomised intranasal dexmedetomidine versus oral melatonin in prevention of emergence delirium in children undergoing ophthalmic surgery with sevoflurane: A randomised double-blind study.

Abstract

BACKGROUND: Melatonin and dexmedetomidine have both been used as a premedication to decrease emergence delirium in children. The effectiveness of oral melatonin, compared with atomised intranasal dexmedetomidine, in this role is not well studied. OBJECTIVE: To study the efficacy of pre-operative atomised intranasal dexmedetomidine versus oral melatonin in children scheduled for ophthalmic surgery under sevoflurane. DESIGN: A prospective, randomised, double-blind trial. SETTING: Ophthalmic surgery in a university teaching hospital, April 2021 to October 2021. PATIENTS: A total of 120 children undergoing ophthalmic surgery with sevoflurane anaesthesia. INTERVENTION: Children were randomised to receive pre-operative intranasal dexmedetomidine 2 μg/kg via an atomiser device (dexmedetomidine group) or oral melatonin 0.5 mg kg -1 (melatonin group), 45 min before surgery. OUTCOMES MEASURED: The primary outcome was the incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale. Secondary outcomes included pre-operative sedation, quality of inhalational induction, postoperative sedation and pain. RESULTS: The incidence of emergence delirium was lower in the dexmedetomidine group than in the melatonin group (17 versus 37%, relative risk 0.45, 95% CI: 0.24 to 0.88; P  = 0.01). Children in the dexmedetomidine group were more sedated following premedication and in the postanaesthesia care unit ( P  < 0.05). Postoperative pain scores were lower in the dexmedetomidine group than in the melatonin group: 0 [0 to 3] versus 2.5 [0-4], ( P  = 0.01). The requirement for and dose of rescue fentanyl analgesia postoperatively was comparable between the two groups. CONCLUSION: Atomised intranasal dexmedetomidine significantly reduced emergence delirium in paediatric opthalmic procedures under sevoflurane anaesthesia compared to oral melatonin. TRIAL REGISTRATION: Clinical Trials Registry of India CTRI/2021/03/032388 ( www.ctri.nic.in ).