Strict warnings to restrict repeated or lengthy use of general anesthesia in children

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Strict warnings to restrict repeated or lengthy use of general anesthesia in children

After the warning issued by the Food and Drug Administration (FDA) recently that the uses of general anesthesia or sedation drugs in young children may harm brain development, some pediatricians are worried that parents may delay important surgeries and thus risktheir childrens life. The warning highlighted the repeated use of general anesthesia in children under 3 years old, or a one-time use during surgery that lasts three hours or more. For the pregnant women, these warnings are applicable to women in their third trimester. As per the recent studies, a single use of anesthesia for a short period is unlikely to have negative effects.

According to the FDA, more than one million children a year in the U.S. under the age of 4 have surgeries that require anesthesia. David Warner, a pediatric anesthesiologist and professor of anesthesiology at the Mayo Clinic, in Rochester, Minn says that only 20% of those end up needing it again while they are still young, and even fewer children undergo surgeries that are three hours or longer. He also added that a majority of parents can be reassured about general anesthesia, who expects many more parents of young children will have questions about its use.

General anesthesia is often used in children for tonsillectomies (surgeries that generally last less than two hours), placing of ear tubes and some gastrointestinal procedures. For longer surgeries, such as fixing a congenital heart problem, or repairing a cleft lip, which usually requires multiple operations, Dr. Warner says he already discusses with parents the potential negative effect of general anesthesia.

As per Randall Flick, president of the Society for Pediatric Anesthesia and a director of the Mayo Clinic Children’s Center, the society worries that the FDA warning “may cause undue concern,” given that there are no clear options to general anesthesia for certain surgeries. Dr. Flick said, “Parents and clinicians should be cautioned that delays in needed procedures may have unintended negative consequences”. For decades, the safety of general anesthesia in young children has been a vexing question. The results of the animal studies depicts that general-anesthetic use kills nerve cells in the brain, which can cause learning, memory and behavioral problems later.

Many recent studies entailing children have found that a single, brief exposure to general anesthesia is unlikely to have a negative impact on learning or behavior. If possible, some families request doing local anesthesia due to the concerns they’ve heard about general anesthesia, said Santhanam Suresh, chairman of pediatric anesthesiology at Ann & Robert H. Lurie Children’s Hospital,Chicago. For instance, spinal anesthetics are sometimes used for hernia repairs in young children, said Dr. Suresh, who is also co-chairman of SmartTots, a nonprofit group formed by the FDA and International Anesthesia Society to encourage research on the effect of general anesthesia on young children.

The FDA requires warnings to be added to the labels of 11 general anesthetic and sedation drugs. As per the agency,  further research is required to determine how early anesthetic exposure affects children’s brain development.

The main challenge for the investigators is that it is not feasible to conduct a randomized, controlled trial on general anesthesia and to prove that anesthesia is the cause of something that may not be evident until years later. Another complication is that most human studies have relied on existing outcomes assembled for other purposes, example school test scores.

Dr. Warner, of the Mayo Clinic, said he is almost towards the completion of a four-year study he expects will help resolve some questions. The study is using a number of neuropsychological tests, like videogames, to see if exposure to anesthesia is related with a particular pattern of injury to brain cells. In this study, about 1,000 children, 7 to 20 years old, about half of whom were exposed to general anesthesia one or more times at a young age. The results are anticipated to be published next year.

Source:

FDA

Link to the source:

http://www.wsj.com/articles/new-concerns-about-anesthesia-for-young-children-1482164447

Original title of article:

FDA warns on repeated or lengthy use of general anesthesia in children

FDA
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