Intranasal dexmedetomidine versus intravenous propofol for the prevention of pediatric emergence delirium following general anesthesia: A randomized controlled trial

Emergence agitation (EA) and emergence delirium (ED) are significant postoperative complications in pediatric anesthesia, requiring effective strategies for prevention and management. This study aimed to evaluate the efficacy of intranasal dexmedetomidine, intravenous propofol, and their combination in reducing the incidence and severity of EA/ED in pediatric patients undergoing dental procedures under general anesthesia. In this randomized, controlled trial, 166 pediatric patients were randomized into three groups: intranasal dexmedetomidine (Group Dex), IV propofol (Group Propofol), or a combination of both (Group Dexofol; 0.5 μg.kg -1 dexmedetomidine and 0.5 mg.kg -1 propofol). The primary outcome was EA/ED severity, assessed using PAED scores at 5, 10, and 15 minutes after extubation. EA/ED incidence was analyzed as a secondary outcome and was defined as a PAED score ≥10 at any assessment during the first 15 minutes after extubation. The incidence of EA/ED was lower in the Dex group (21.8%; relative risk [RR] versus the Propofol group, 0.36; 95% confidence interval [CI], 0.21–0.61) and the Dexofol group (29.8%; RR, 0.49; 95% CI, 0.31–0.77) than in the Propofol group (61.1%). PAED scores at 5 minutes post-extubation were significantly lower in the Dex group, and at 10 minutes were significantly lower in both the Dex and Dexofol groups compared to the Propofol group ( p <0.05). Time to PACU discharge readiness was shorter in the Dex group (13.1 ± 2.7 minutes) and the Dexofol group (14.0 ± 3.4 minutes) than in the Propofol group (17.5 ± 4.4 minutes; both p <0.001). Intranasal dexmedetomidine was associated with a lower incidence and severity of EA/ED and earlier achievement of PACU discharge readiness than intravenous propofol. The findings related to the reduced-dose dexmedetomidine–propofol regimen should be regarded as hypothesis-generating, as the study design did not allow differentiation between additive, dose-sparing, and agent-specific effects. ClinicalTrials.gov, NCT06466915. Prospectively registered on 14 June 2024.