Long-term Outcomes After Protocolized Sedation vs Usual Care in Ventilated Pediatric Patients.

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Abstract

RATIONALE

Whether a nurse-implemented goal-directed sedation protocol resulting in more awake yet calm intubated children affects post-discharge functional status, health-related quality of life, or risk for post-traumatic stress disorder is unknown.

OBJECTIVES

To compare post-discharge outcomes in children with acute respiratory failure cluster randomized to a sedation protocol or usual care.

METHODS

A stratified random sample of 1360 patients from 31 centers in the Randomized Evaluation of Sedation Titration for Respiratory Failure trial was assessed by mail, electronically, and/or telephone six months after intensive care unit discharge. In treatment group comparisons, we controlled for age, baseline functional status, and severity of illness.

MEASUREMENTS AND MAIN RESULTS

We used the Pediatric Overall and Cerebral Performance categories to characterize functional status, the Infant and Toddler Quality of Life Questionnaire-97 (<2 years old) or Pediatric Quality of Life Inventory (≥2 years old), and the Child Post-traumatic Stress Disorder Symptom Scale (≥8 years old and developmentally able). Functional status worsened from baseline to follow-up in 20%. Decline in functional status did not differ by treatment arm and was more common among those with baseline impairment than those with baseline normal function (27% vs. 18%; P<0.001). There were no significant differences in health-related quality of life total scores by treatment arm. Scores indicating risk of post-traumatic stress disorder occurred in 30%, with no difference between treatment arms.

CONCLUSIONS

A sedation strategy that allows patients to be more awake and exposes them to fewer sedative and analgesic medications produces no long-term harm. However, post-discharge morbidity after acute respiratory failure is common. Clinical trial registration available at www.clinicaltrials.gov, ID NCT00814099.

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