Document Type : original article


1 Department of Clinical Pharmacy, Faculty of pharmacy, Mazandaran University of Medical Sciences, Sari, Iran

2 Pediatric Infectious Diseases Research Center, Mazandaran University of Medical Sciences, Sari, Iran.

3 Pharmaceutical Sciences Research Center, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran


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 stability.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.


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