title: Defining sedation-related adverse events in the pediatric intensive care unit.
abstract: BACKGROUND
  Clinical trials exploring optimal sedation management in critically ill pediatric patients are urgently needed to improve both short- and long-term outcomes. Concise operational definitions that define and provide best-available estimates of sedation-related adverse events (AE) in the pediatric population are fundamental to this line of inquiry.
  
  
  OBJECTIVE
  To perform a multiphase systematic review of the literature to identify, define, and provide estimates of sedation-related AEs in the pediatric ICU setting for use in a multicenter clinical trial.
  
  
  METHODS
  In Phase One, we identified and operationally defined the AE. OVID-MEDLINE and CINAHL databases were searched from January 1998 to January 2012. Key terms included sedation, intensive and critical care. We limited our search to data-based clinical trials from neonatal to adult age. In Phase Two, we replicated the search strategy for all AEs and identified pediatric-specific AE rates.
  
  
  RESULTS
  We reviewed 20 articles identifying sedation-related adverse events and 64 articles on the pediatric-specific sedation-related AE. A total of eleven sedation-related AEs were identified, operationally defined and estimated pediatric event rates were derived. AEs included: inadequate sedation management, inadequate pain management, clinically significant iatrogenic withdrawal, unplanned endotracheal tube extubation, post-extubation stridor with chest-wall retractions at rest, extubation failure, unplanned removal of invasive tubes, ventilator-associated pneumonia, catheter-associated bloodstream infection, Stage II+ pressure ulcers and new tracheostomy.
  
  
  CONCLUSIONS
  Concise operational definitions that defined and provided best-available event rates of sedation-related AEs in the pediatric population are presented. Uniform reporting of adverse events will improve subject and patient safety.
authors: Pediatric Critical Care, Primary Children's Medical Center, 100 North Mario Capecchi Drive, Salt Lake City, UT 84113, USA. maryjo.grant@imail.org
authors: Mary Jo C
authors: MJ
authors: Grant
authors: Michele C
authors: MC
authors: Balas
authors: Martha A Q
authors: MA
authors: Curley
mesh_terms: D002648:Child; D016292:Procedural Sedation / Q000009:adverse effects*; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness / Q000628:therapy*; D014943:Global Health; D006801:Humans; D015994:Incidence; D015278:Intensive Care Units, Pediatric; D012131:Respiratory Insufficiency / Q000453:epidemiology / Q000209:etiology*; D012307:Risk Factors
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