Considers Data on Potential Risks of Anesthesia Use in Infants, Children

Pediatric Anesthesia


FDA Considers Data on Potential Risks of Anesthesia Use in Infants, Children


Kuehn BM JAMA 305:1749-1750, 2011§



S. Black, MD



Evidence Ranking


• B



Expert Rating


• 2



Abstract



Background


The Food and Drug Administration (FDA) has voiced concern over whether anesthesia may harm infants or young children, producing later developmental or emotional problems. Much of the evidence comes from animal studies and suggests that developing brains may be damaged by anesthetic agents, causing lasting behavioral and cognitive deficits. Clinical studies suggest that later cognitive deficits may develop after pediatric patients are exposed to anesthetics under some conditions, but not others. However, no conclusive evidence links exposure to anesthesia or sedative drugs to neurotoxicity or neurodevelopmental abnormalities. Without such evidence, the FDA panel meeting has concluded that it is unethical to have a child undergo a fear-producing or painful procedure without sedation.



Animal Studies


When animals are exposed to anesthetics during critical stages of brain development, they experience widespread brain cell death, with resulting long-term effects on behavior, cognition, or both. No specific anesthetic agent or regimen has been proven safer than others. However, it is difficult to translate the window of vulnerability from rats to humans because rat brains develop over a relatively short time compared to human brain patterns. When young primates are tested, however, the results were similar to those found with rats. Studies indicate it is likely there are doses and levels that can be used without risking adverse effects. A study involving the exposure of fetal and neonatal rhesus monkeys to isoflurane, ketamine, or propofol indicated that ketamine was most toxic for fetuses, isoflurane was more toxic for neonates, and propofol had the least toxicity. Neurotoxicity has also varied depending on the effects of other drugs, such as caffeine. Many factors can complicate the outcomes of studies on the effects of anesthesia. The neurologic changes that result from exposure to anesthesia early in life can have lasting effects on cognition and behavior. Studies of rhesus monkeys have shown that ketamine exposure can alter the motivation and capacity to work for food and the ability to perform cognitive tasks. These results were permanent.

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Jan 28, 2017 | Posted by in ANESTHESIA | Comments Off on Considers Data on Potential Risks of Anesthesia Use in Infants, Children

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