title: Safety and Effectiveness of Dexmedetomidine in the Pediatric Intensive Care Unit (SAD-PICU).
abstract: BACKGROUND
  Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. Dexmedetomidine is a newer sedative with little safety data in pediatrics, particularly for therapy lasting longer than 48 h.
  
  
  OBJECTIVE
  To quantify the frequency of adverse events and withdrawal syndromes associated with dexmedetomidine and to describe the use of this drug for continuous sedation in critically ill children.
  
  
  METHODS
  In this retrospective study of patients who received dexmedetomidine for sedation in the pediatric intensive care unit, adverse events were assessed with the Naranjo scale to determine the likelihood of association with dexmedetomidine. Interventions in response to adverse events were also recorded.
  
  
  RESULTS
  One hundred and forty-four patients (median age 34 months, range 0 - 17.7 years) who underwent a total of 153 treatment courses were included. The mean infusion rate of dexmedetomidine was 0.42 μg/kg per hour (standard deviation 0.17 μg/kg per hour, range 0.05-2 μg/kg per hour). The median duration of therapy was 20.50 h (range 0.75-854.75 h), and 70 infusions (46%) lasted more than 24 h. At least one adverse event was observed in 115 (75%) of the treatment courses. Hypotension (81 [53%]) and bradycardia (38 [25%]) were the most common adverse events and were deemed "probably" attributable to dexmedetomidine in 17 (11%) and 9 (6%) of the treatment courses, respectively. In 55 of the 66 treatment courses with infusions lasting longer than 24 h for which post-infusion data were available, at least one withdrawal symptom was observed; agitation (41 [62%]) and hypertension (22 [33%]) were the most common withdrawal symptoms.
  
  
  CONCLUSIONS
  Dexmedetomidine was commonly administered for longer than 24 h in the authors' institution. Dexmedetomidine was generally well tolerated; however, the majority of patients experienced withdrawal symptoms. Patients receiving dexmedetomidine for more than 24 h should be monitored for withdrawal following discontinuation, and interventions should be provided if needed. Prospective, controlled studies are needed to characterize the safety of long-term dexmedetomidine therapy in critically ill children.
authors: , BSc(Pharm), ACPR, is with the Department of Pharmacy, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia.
authors: Laura
authors: L
authors: Carney
authors: Jennifer
authors: J
authors: Kendrick
authors: Roxane
authors: R
authors: Carr
keywords: children; critical care; dexmedetomidine; dexmédétomidine; enfants; sedation; soins intensifs; sédation