Remimazolam for Pediatric Procedural Sedation: Results of an Institutional Pilot Program

Abstract

Remimazolam, an ultra-short-acting benzodiazepine sedative, was first approved in 2020 in Japan as a general anesthetic for adults. However, its utilization in pediatric settings remains unexplored and, to date, is confined to isolated case reports due to a lack of specific pediatric labeling. The primary objective of our study was to evaluate the safety profile of remimazolam when used for procedural sedation in children following dosages established in adult protocols. Additional parameters, including dosage per kg of body weight, duration of the procedure, efficacy (measured as successful completion of the procedure), the necessity for supplemental medications, and changes in physiological parameters, such as the heart rate (HR) and mean arterial blood pressure (MAP), were assessed. Our study encompassed 48 children with an average age of 7.0 years. The objective Tracking and Reporting Outcomes of Procedural Sedation tool indicated no adverse events. In our cohort, propofol and ketamine were used as adjunctive treatments in 8 and 39 patients, respectively, with successful completion of all procedures. Notable hemodynamic variability was observed, with 88.4% of patients experiencing a ≥20% change (increase or decrease) and 62.8% experiencing a ≥30% change in MAP. Additionally, a ≥20% change in HR was observed in 54.3% of patients, and a ≥30% change was observed in 34.8% of patients. Nevertheless, none of the patients required pharmacological intervention to manage these hemodynamic fluctuations. Our findings suggest that remimazolam, when supplemented with propofol or ketamine, could offer a safe and effective pathway for administering procedural sedation in pediatric populations.

Keywords: pediatrics; remimazolam; sedation.

Figure 1

Distribution of the lowest mean arterial pressure (MAP) change from baseline observed in the 40 pediatric patients during the procedure. The x-axis represents the percentage change in MAP, while the y-axis represents the percentage of subjects. MAP change is divided into three distinct groups: 0% to −20% change, −20% to −30% change, and −30% or greater change.

Figure 2

Distribution of the highest mean arterial pressure (MAP) change from baseline observed in the 37 pediatric patients during the procedure. The x-axis represents the percentage change in MAP, while the y-axis represents the percentage of subjects. MAP change is divided into three distinct groups: 0% to 20% change, 20% to 30% change, and 30% or greater change.

Figure 3

Distribution of the lowest heart rate (HR) changes from baseline observed in 32 pediatric patients during the procedure. The x-axis represents the percentage change in HR, while the y-axis represents the percentage of subjects. HR change is divided into three distinct groups: 0% to −20% change, −20% to −30% change, and −30% or greater change.

Figure 4

Distribution of the highest heart rate (HR) change from baseline observed in 46 pediatric patients during the procedure. The x-axis represents the percentage change in HR, while the y-axis represents the percentage of subjects. HR change is divided into three distinct groups: 0% to 20% change, 20% to 30% change, and 30% or greater change.