Intranasal Dexmedetomidine vs. Oral Midazolam in Pediatric Emergence Agitation Management Following Anesthesia; A Double Blind Randomized Clinical Trial.

Emergence agitation (EA) occurs shortly after emergence from anesthesia in pediatric patients causing disorientation, restlessness, and non-purposeful movement. This study aimed to compare intranasal dexmedetomidine (DEX) and oral midazolam in managing EA in pediatric patients scheduled for neurosurgical procedures. This double-blinded randomized clinical trial was conducted on 50 pediatric patients who underwent neurosurgical procedure in an educational hospital between March and June 2024. One group received intranasal DEX (2 mcg/kg) and other group received oral midazolam (1 mg/kg of midazolam) before induction of anesthesia. The rate of EA as well as vital signs changes were compared between the two groups using statistical analysis. 50 participants were enrolled in the study and randomly divided to DEX and midazolam groups (25 participants in each group). The two groups were similar regarding age (p = 0.538); sex (p = 0.417); pre-operation heart rate (p = 0.675); systolic (p = 0.226) and diastolic (p = 0.753) blood pressure; and pre-operative mean arterial blood pressure (p = 0.634). Among all participants, 13 (26.00%) patients showed signs of EA after extubation (2 patients (8.00%) in DEX group and 11 (44.00%) patients in midazolam group; p = 0.004). Regrading vital signs, only the decrease in heart rate after extubation in the DEX group was significantly greater than that observed in the midazolam group (-9.28±12.88 vs. -2.48±8.23, respectively; p = 0.0310). The number needed to treat (NNT), relative risk reduction (RRR), and absolute risk reduction (ARR) of using intranasal DEX in management of EA were 2.77 (95%confidence interval (CI): 1.72-7.19), 81.8% (95%CI: 26.0%-95.5%), and 36.0% (95%CI: 13.9%-58.1%) respectively. Intranasal DEX compare to oral midazolam demonstrated superior efficacy in managing postoperative EA in pediatric patients.