(899) Procedure Sedation in Spontaneously Breathing Children: A Randomized Clinical Trial

Introduction: Sedation and analgesia for procedures outside the operating room are increasing, especially in emergency rooms and pediatric intensive care units (PICUs). Painful procedures like central venous catheter (CVC) insertion require sedation, analgesia, and immobility to ensure patient well-being and safety, reducing inherent risks. It is believed that analgesia and sedation for pediatric procedures are often suboptimal. This study aims to compare the success rates of CVC and peripherally inserted central catheter (PICC) insertions in spontaneously breathing pediatric patients using a combination of ketamine and dexmedetomidine versus standard sedation (usual care) in the PICU.

Methods: This open-label, non-inferiority, randomized controlled trial was conducted in a university hospital PICU. Children aged over 28 days and under 14 years, spontaneously breathing and requiring CVC or PICC insertion, were eligible. After informed consent, subjects were randomized to either the intervention group (ketamine 1 mg/kg bolus and dexmedetomidine 1 mcg/kg over 3 minutes, followed by continuous dexmedetomidine infusion at 0.5 mcg/kg/h) or the control group (standard sedation and analgesia). Additional doses of ketamine and adjustments to dexmedetomidine were given as needed. Clinical and hemodynamic variables were assessed to compare outcomes.

Results: From March 2020 to January 2024, 70 children were analyzed (34 intervention, 36 control). Success rates for procedures were similar (88.2% vs. 80.6%, p = 0.378). Satisfaction was higher in the intervention group (76.2% vs. 50%, p = 0.022). Adverse events and additional medication doses were similar. No significant differences in clinical parameters, procedure duration, or recovery times were observed. FLACC and COMFORT-B scores were lower in the intervention group (p < 0.001).

Conclusions: Ketamine and dexmedetomidine are as effective as usual care for pediatric sedation, offering higher satisfaction without compromising safety or efficacy. This combination may improve patient comfort during procedures.