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PEDIATRICS Vol. 112 No. 4 October 2003, pp. 1002-1003

The FDA Warning Against Prolonged Sedation With Propofol in Children Remains Warranted

Kate Felmet, MD
Trung Nguyen, MD
Robert S. Clark, MD
Dick Orr, MD
Joseph Carcillo, MD
Children’s Hospital of Pittsburgh, Department of Critical Care Medicine, Pittsburgh, PA 15213

The first 20% of the full text of this article appears below.

To the Editor.—

We read with concern the article published by Cornfield et al1 describing the use of propofol for long-term sedation in critically ill children. The authors conclude that their study "provides justification for continued use of propofol in the pediatric intensive care unit (PICU) setting." The design of the study, without controls or investigation of markers defining propofol infusion syndrome, precludes any statement that the drug is safe for prolonged use in children.

An unpublished randomized, controlled trial of propofol in 327 pediatric patients reviewed by the Food and Drug Administration (FDA) described a concentration-dependent increase in 28-day mortality in propofol-treated patients with a trend toward significance. The group receiving standard sedatives had a 4% mortality, those treated with 1% propofol had an 8% mortality, and those treated with 2% propofol had an 11% mortality.2 Pediatric Risk of Mortality (PRISM) scores for the 3 groups were 7.5, 7.2, and 7.5, respectively. Although the concentration of propofol used is not given in the present study, the authors report a 7% mortality rate similar to the 1% treatment group in the FDA-reviewed study. In our own PICU, . . . [Full Text of this Article]


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