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Children admitted to pediatric intensive care units (PICUs) often receive sedatives to facilitate mechanical ventilation. However, despite their widespread use, data supporting appropriate dosing, safety, and optimal regimens for sedation during mechanical ventilation are lacking. Therefore, we conducted a systematic review of published data regarding efficacy of sedation to facilitate mechanical ventilation in PICU patients. Our primary objective was to identify and evaluate the quality of evidence supporting sedatives used in PICUs for this purpose.We searched MEDLINE, EMBASE, and The Cochrane Registry of Clinical Trials from 1966 to June 2008 to identify published articles evaluating sedation regimens to facilitate mechanical ventilation in PICU patients.We included only those studies of intubated PICU or pediatric cardiac intensive care unit patients receiving pharmacologic agents to facilitate mechanical ventilation that reported quality of sedation as an outcome.We analyzed studies separately for study type and by agents being studied. Studies were appraised using criteria of particular importance for reviews evaluating sedatives.Our search strategy yielded 39 studies, including 3 randomized trials, 15 cohort studies, and 21 cases series or reports. The 39 studies evaluated a total of 39 different sedation regimens, with 21 different scoring systems, in a total of 901 PICU/cardiac intensive care unit patients ranging in age from 3 days to 19 years old. Most of the studies were small (<30 patients), and only four studies compared one or more agents to another. Few studies thoroughly evaluated drug safety, and only one study met all quality criteria.Despite the widespread use of sedatives to facilitate mechanical ventilation in the PICU, we found that high-quality evidence to guide clinical practice is still limited. Pediatric randomized, controlled trials with reproducible methods and assessment of drug safety are needed.