Dexmedetomidine versus Fentanyl in Children Undergoing Central Venous Catheter Placement at the Pediatric Intensive Care Unit: A Randomized Double-Blind Clinical Trial

Background: The amount of sedation required for children in the pediatric intensive care unit (PICU) is a usually challenging issue. Fentanyl is a commonly used sedative in PICU, but respiratory depression limits its use. Dexmedetomidine (DEX) is an effective sedative and anesthetic agent with negligible respiratory depression and hemodynamic stabili :This study was aimed to assess the effects of using DEX as a sedative in comparison to fentanyl. Methods: We conducted a randomized double-blind clinical trial on children aging 1 month to 18 years who were required central venous catheter at PICU. The patients were randomized into the DEX and fentanyl (loading dose 1 mcg/kg and 1 mcg/kg/h for continuous infusion) groups. The primary outcome was defined as the time to achieve Ramsay Sedation Scale (RSS) >= 3, along with the safety outcome. Results: A total of 55 patients were recruited for the analysis between July 7 and December 30, 2020. The two groups were comparable at baseline. There was no statistical difference in the number of patients (63% in DEX and 50% in fentanyl group p=0.39) and the time of reaching RSS >= 3 (10 min for DEX and 15 min for fentanyl group p=0.098). Furthermore, the catheterization time between the two groups was not different when the agents were administered individually or with propofol (15 min for DEX and 17.5 min for fentanyl, p=0.225, and 22.5 for DEX and 30 min for fentanyl group, p=0.075 respectively); neither was the safety profile significantly different in the two groups. Conclusions: This study found that DEX as a primary sedative is non-inferior to fentanyl, and it could facilitate sedation alone or in combination with propofol.