Author Of 1 Presentation
IS DEXMEDETOMIDINE EFFECTIVE AND SAFE FOR PROLONGED SEDATION IN CRITICALLY-ILL PEDIATRIC PATIENTS? A PROSPECTIVE MULTICENTER STUDY (PROSDEX)
Abstract
Background
Dexmedetomidine (DEX) is a selective-alpha-2-adrenergic-agonist recently authorized by Italian-Medicines-Agency for difficult sedation in pediatrics. Few data exist regarding prolonged infusions and no prospective study has systematically evaluated its efficacy so far.
Objectives
To evaluate DEX efficacy and safety for prolonged sedation in PICU.
Methods
Patients <18years receiving DEX≥24 hours in 9PICUs were included. Indications, dosages, efficacy and safety were systematically evaluated. Efficacy was defined as reduction of validated clinical-scores (Comfort-Behavior-Scale, CBS; Withdrawal-Assessment-Tool-1, WAT-1; Cornell-Assessment-of-Pediatric-Delirum, CAPD) and sparing of analgesics and sedatives. Every potential adverse-event (AE) was registered.
Results
A calculated sample-size of 163 patients (median-age 13months, IQR 4-71) were enrolled. Main indication was adjuvant for drug-sparing (42.3%). Seven-percent of patients received a loading-dose. Median infusion-duration was 108 hours (IQR 60-168) with dosages between 0.4 (IQR 0.3-0.5) and 0.8mcg/kg/h (IQR 0.6-1.2). Median time of infusion-weaning was 24 hours (IQR 5-48). Twenty-three patients (14.1%) received DEX as solo-sedation, 61% with other sedatives, 81% with other analgesics. After DEX-starting, CBS, WAT-1 and CAPD significantly reduced (p<0.001,p<0.001,p=0.027) as well as the dosages/kg/h of benzodiazepines, opioids, propofol and ketamine (p<0.001,p<0.001,p=0.001,p=0.027). Thirty-seven-percent of patients presented hemodynamic-AEs not-requiring intervention while 8.6% presented hemodynamic-AEs requiring intervention (79% dose-reduction). In multivariate models a loading-dose was associated with hemodynamic AEs (p=0.043) and the use of aminergic-inotropic-drugs was associated with severe hemodynamic-AEs (p=0.011).
Conclusion
DEX prolonged infusion assures comfort, allows sparing of opioids and benzodiazepines and helps to treat withdrawal-syndrome and delirium. AEs are mainly hemodynamic and easily reversible with dose-reduction. The loading-dose and the concomitant use of aminergic-inotropic-drugs are independent risk factors for hemodynamic-AEs.