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 μ kg-1 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).
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