Procedural mild-to-moderate sedation and analgesia in the Pediatric Emergency Department: single- vs multi-drug management. A comparative analysis.

Introduction: Children undergoing diagnostic or therapeutic procedures in the Pediatric Emergency Department (PED) frequently experience pain, fear, and anxiety. Mild-to-moderate procedural sedation and analgesia (PSA) is an effective strategy to facilitate painful or anxiety-provoking procedures. Systematic recording of PSA practices and outcomes through dedicated registries is essential to monitor safety, evaluate quality of care, and support continuous improvement. Objective: To describe mild-to-moderate pediatric PSA current practice at the PED and associated acute patient ward of the University Hospital of Padua and to compare single-drug and multi-drug PSA procedure strategies regarding pharmacological management, sedation effectiveness and safety profile monitoring adverse events and administration of supplemental drug doses. Materials and Methods: We conducted a single-center observational cross-sectional study using prospectively collected data from children (0–15 years) who underwent mild-to-moderate PSA in the above settings. Since July 2025, all PSA involving parenteral medication administration have been recorded in an institutional REDCap® platform, mirroring the previously used paper form. Variables included demographic data, medical history, physical examination, fasting times, type of procedure, sedative and analgesic agents with routes of administration, clinical setting, monitoring, sedation state assessment (PSSS scale), adverse events and rescue interventions. Date from July 2024 and July 2025 on Ketamine sedations were transferred from the paper forms to the digital registry. Results: Of 200 procedures, 176 (88.0%) were performed in the PED and 132 (66.0%) used a multi-drug regimen. Wound suturing (47.0%) and diagnostic imaging requiring immobility (31.0%) were the most common indications. Ketamine was the most frequently used agent (86.0%, n = 172), with ketamine–midazolam being the predominant combination (49.5%, n = 99). Two or more supplemental doses were required more frequently with multi-drug than with single-drug regimens (35.6%, n = 47 vs 10.3%, n = 7; p = 0.001). Pediatric sedation state scale (PSSS) scores, available for 30.5% of procedures, indicated adequate sedation in most cases. Adverse events occurred in 13 procedures (6.5%), were mainly minor and transient, and did not differ significantly between groups. No patients required the intervention of intensive care or anesthesiology to manage the adverse events. Conclusions: Mild-to-moderate pediatric PSA carried out by pediatricians trained in pediatric emergency demonstrated a favorable safety profile, with a low rate of mostly minor adverse events in both single-drug and multi-drug sedation strategies. Data recording about PSSS needs to be improved in order to evaluate sedation effectiveness. Registry-based data collection provided a valuable overview of real-world practice and highlighted the need for more complete and standardized documentation to optimize sedation quality and monitoring.