Effect of oral premedication of midazolam, ketamine, and dexmedetomidine on pediatric sedation and ease of parental separation in anesthesia induction for elective surgery: A randomized clinical trial

Abstract

Objective: To compare effect of midazolam, dexmedetomidine, and ketamine as oral premedication on pediatric sedation and ease of parental separation anxiety in anesthesia induction. Methods: This multicenter, prospective, randomized, double-blind, clinical trial focused on a pediatric population aged 2-7 years (n=153) with the American Society of Anesthesiologists I-II who required elective surgery. The patients were stratified into three intervention groups: midazolam, ketamine, and dexmedetomidine. Hemodynamic parameters (blood pressure, heart rate, and oxygen saturation) every 5 min until induction of anesthesia along with non-hemodynamic factors, comprised of sedation score before the administration and at the time of being separated from the parents, as well as parental separation anxiety scale, acceptance of anesthesia induction, and side effects were recorded and compared. Results: No statistically significant difference in oxygen saturation, heart rate, blood pressure, duration of surgery, time to achieve an Aldrete score of 9-10, or sedation score was noted in the study groups. More patients in the dexmedetomidine and midazolam groups could better ease parental separation anxiety than the ketamine group (P=0.001). Moreover, fewer patients accept anesthesia induction (P=0.001) and more had side effects in the ketamine group (P=0.047). Conclusions: Our findings indicate that compared to the ketamine group, dexmedetomidine and midazolam are better in easing parental separation anxiety and accepting induction of anesthesia with fewer side effects. Dexmedetomidine and midazolam may be considered better choices. However, the final choice hinges on the patient′s specific physical condition and the anesthesiologist′s preference. Clinical registarion: This study is registered in the Iranian Registry Clinical Trial center with the clinical trial code of IRCT20211007052693N1.