Preventive effect of ramelteon on emergence agitation after general anaesthesia in paediatric patients undergoing tonsillectomy: a randomised, placebo-controlled clinical trial.

Abstract	Purpose of this prospective, double-blind, parallel-group, placebo-controlled, randomised clinical trial was to confirm our hypothesis that ramelteon has a preventive effect on emergence agitation after general anaesthesia in children. Patients aged 18 to 119 months (ASA physical status 1 or 2), scheduled to undergo tonsillectomy under general anaesthesia, were randomly allocated to the ramelteon or placebo group. Before general anaesthesia induction, patients in the ramelteon group received 0.1 mg kg-1 of ramelteon dissolved in 5 mL of lactose-containing syrup. The patients in the placebo group received the same amount of syrup alone. The Paediatric Anaesthesia Emergence Delirium score was calculated every 5 min after awakening. The primary outcome was the incidence of emergence agitation (Paediatric Anaesthesia Emergence Delirium score ≥ 10). Paediatric Anaesthesia Emergence Delirium scores, post-operative vomiting incidence, pain scores, and adverse events were secondary outcomes. Fifty patients were enrolled. Forty-eight patients were analysed. There was no significant between-group difference in the incidence of emergence agitation (67% in both groups; risk ratio, 1.0; 95% CI 0.67-1.49; P > 0.99) or any of the secondary outcomes. Our results suggest that 0.1 mg kg-1 of ramelteon does not have a preventive effect on emergence agitation after general anaesthesia in children undergoing tonsillectomy.
Authors	Maya Komazaki, Takahiro Mihara, Nobuhito Nakamura, Koui Ka, Takahisa Goto
Journal	Scientific reports (Sci Rep) Vol. 10 Issue 1 Pg. 21996 (12 15 2020) ISSN: 2045-2322 [Electronic] England
PMID	33319866 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Indenes Placebos ramelteon
Topics	Anesthesia, General (adverse effects) Child Child, Preschool Emergence Delirium (drug therapy, etiology, prevention & control) Female Humans Indenes Infant Male Placebos Tonsillectomy Treatment Outcome

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