Prolonged sedation in critically ill children: is dexmedetomidine a safe option for younger age? An off-label experience

Francesca Sperotto, Maria C Mondardini, Francesca Vitale, Marco Daverio, Emiliana Campagnano, Federica Ferrero, Emanuele Rossetti, Beatrice Vasile, Maria P Dusio, Stefania Ferrario, Fabio Savron, Luca Brugnaro, Angela Amigoni, Pediatric Neurological Protection and Drugs (PeNPAD) Study Group, Fabio Caramelli, Giorgio Conti, Stefano Furlan, Silvana Molinaro, Andrea Pettenazzo, Sergio Picardo, Fabrizio Racca, Ida Salvo, Francesca Sperotto, Maria C Mondardini, Francesca Vitale, Marco Daverio, Emiliana Campagnano, Federica Ferrero, Emanuele Rossetti, Beatrice Vasile, Maria P Dusio, Stefania Ferrario, Fabio Savron, Luca Brugnaro, Angela Amigoni, Pediatric Neurological Protection and Drugs (PeNPAD) Study Group, Fabio Caramelli, Giorgio Conti, Stefano Furlan, Silvana Molinaro, Andrea Pettenazzo, Sergio Picardo, Fabrizio Racca, Ida Salvo

Abstract

Background: Dexmedetomidine (DEX) is an alpha-2-adrenergic agonist, recently approved by Italian-Medicines-Agency for difficult sedation in pediatrics, but few data exist regarding prolonged infusions in critically-ill children, especially in younger ages. Aim of our study was to evaluate DEX use and safety for prolonged sedation in Pediatric Intensive Care Units (PICUs).

Methods: Patients receiving DEX for ≥24 hours were retrospectively evaluated to analyze DEX indications, dosages, use of analgesics or sedatives, adverse events (AEs), withdrawal syndrome or delirium.

Results: Forty-seven patients (median 0.7years) from nine PICUs were enrolled. Main indications were adjuvant for drugs sparing (59.6%) and for analgosedation weaning (36.2%). Median infusion duration was 82.0 hours (IQR 62.2-126.0), with dosages between 0.4 (IQR 0.2-0.5) and 0.8 mcg/kg/h (IQR 0.6-1.2). Fifty-nine-percent of patients received other sedatives, 83% other analgesics. Twenty-one-percent presented withdrawal syndrome, 4.2% delirium, none of them DEX-related. Forty-six-percent experienced a potentially-DEX-related AE. AEs were all hemodynamic, 14.9% requiring intervention but none DEX interruption. The median minimum and maximum dosages were significantly higher in patients with AEs (0.5 vs. 0.3,P=0.001; 1.0 vs. 0.7,P<0.001), without correlations with the infusion duration. AEs rate was higher in patients receiving benzodiazepines (P=0.020) or more than one analgesic (P=0.003) and in those presenting withdrawal syndrome (P<0.001).

Conclusions: DEX was confirmed as useful and relatively safe drug for prolonged sedation in critically-ill children, particularly in younger ages. Main AEs were cardiovascular, reversible, related with higher doses, with the concomitant use of benzodiazepines or multiple sedation drugs and with the presence of withdrawal syndrome.

Source: PubMed

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