What are the risks of pediatric anesthesia? What should you do if your 2-year-old son or daughter requires surgery and anesthesia? Is the anesthetic risky? Should you consent to proceed? Should you wait until he or she is 3 years old?
The answer to all these questions is: “It depends.”
Let’s look at recommendations as they exist in 2018.
On December 14, 2016, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication Drug Safety Communication Warning that general anesthesia and sedation drugs used in children less than 3 years of age who were undergoing anesthesia for more than 3 hours, or repeated use of anesthetics, “may affect the development of children’s brains.”
The text of this December 2016 FDA statement reads:
“The U.S. Food and Drug Administration (FDA) is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. . . . Consistent with animal studies, recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. However, further research is needed to fully characterize how early life anesthetic exposure affects children’s brain development. . . . Health care professionals should balance the benefits of appropriate anesthesia in young children and pregnant women against the potential risks, especially for procedures that may last longer than 3 hours or if multiple procedures are required in children under 3 years. Discuss with parents, caregivers, and pregnant women the benefits, risks, and appropriate timing of surgery or procedures requiring anesthetic and sedation drugs.”
This FDA warning resulted in a labeling change for these 11 common general anesthetics drugs and sedative agents:
Of these, sevoflurane and propofol are mainstay drugs used in pediatric anesthetics. Anesthesia for infants and children is most frequently initiated with an inhalation induction of sevoflurane vapor, because most infants and children do not have an IV line prior to induction. The primary intravenous hypnotic drug for children is propofol.
Because of this FDA statement, the propofol package insert warning label now reads:
“Pediatric Use; ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY). Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.”
For sevoflurane, the package insert warning label now reads:
“Repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in neonates, infants, and children younger than 3 years, including in utero exposure during the third trimester, may have negative effects on brain development. Consider the benefits of appropriate anesthesia in young children against the potential risks, especially for procedures that may last more than 3 hours or if multiple procedures are required during the first 3 years of life. It may be appropriate to delay certain procedures if doing so will not jeopardize the health of the child. No specific anesthetic or sedation drug has been shown to be safer than another. Human studies suggest that a single short exposure to a general anesthetic in young pediatric patients is unlikely to have negative effects on behavior and learning; however, further research is needed to fully characterize how anesthetic exposure affects brain development.”
There are no real alternatives to these 11 general anesthetic drugs regarding pediatric anesthesia. Dexmedetomidine and narcotics are not on the FDA list, but dexmedetomidine and narcotics are not sufficient to provide general anesthesia by themselves.
What does this mean to physicians and parents regarding anesthetics on children under the age of 3 years?
The most common indications for infants and toddlers to be placed under general anesthesia are for short procedures such as ear tubes for chronic ear infections, hernia repair, or removal of the adenoids. At times infants or toddlers require general anesthesia or sedation so they will stay still during a procedure, such as when they need an MRI or a CT scan.
There are an estimated 1.5 -2 million children under 3 years of age who undergo anesthesia annually in the United States. Prior to the FDA statement, Texas Children’s Hospital performed more than 43,000 cases each year. Approximately 13,000 of these cases involved patients under 3 years of age, and more than 11,000 of these anesthetics lasted more than 3 hours. Nearly all of the prolonged anesthetics were for serious congenital conditions for which treatment could not be delayed until the patient reached 3 years of age. Because of the FDA warning, the hospital adopted the warning’s recommendation that a discussion occur among parents, surgeons and other physicians, and anesthesiologists regarding the duration of anesthesia, any plan for multiple general anesthetics for multiple procedures, and the possibility that the procedure could be delayed until after 3 years of age.1
Dr. Constance Houck, chair of the American Academy of Pediatrics’ Surgical Advisory Panel and an Associate Professor of Anesthesia at Harvard Medical School said, “two recently published studies examining short-term anesthesia exposure for hernia repair did not show neurobehavioral differences between those who had received a general anesthetic and those who had not. . . . Most surgeries are less than one hour, but some infants and children with significant congenital defects require more prolonged surgery. . . Examples would include such defects as cleft lip and palate and malformations of the urinary or gastrointestinal tract.” Postponing major reconstructive surgery until children are older is generally not an option. “There is no evidence to suggest that short procedures should be postponed, but parents should always discuss with their child’s pediatrician and surgeon the risks and benefits of timing of procedures.”2
The American Society of Anesthesiologists response to the FDA statement read: “the accumulated human data suggest that one brief anesthetic is not associated with cognitive or behavioral abnormalities in children. Most but not all studies in children do however suggest an association between repeated and or prolonged exposure and subsequent difficulties with learning or behavior.”3
In addition to the FDA drug recommendations, there are well documented surgical concerns with operating on children under age 3. For example, the recommendations for pediatric tonsillectomy are to delay until age 3, based on a high degree of evidence for increased respiratory complications at ages younger than 3.4
An overriding important consideration regarding pediatric anesthetics is: Who will be doing the anesthesia? It’s important to inquire regarding the experience and training of the physician anesthesiologist who is about to anesthetize your child. (See my related column Pediatric Anesthesia: Who is Anesthetizing Your Child?)
Some anesthesiologists do specialty fellowship education for one or two years in pediatric anesthesia, usually at an academic pediatric hospital, and are therefore well-trained to attend to your child. In community hospitals, experienced physician anesthesiologists who have attended to children since their residency training commonly do pediatric anesthetics. My practice fits this model: I am not a fellowship-trained pediatric anesthesiologist, but I have anesthetized thousands of children safely over 33+ years since my Stanford residency.
Let’s return to the question of whether your 2-year-old should have anesthesia and surgery.
My family had a personal experience with this question. My oldest son fell and cracked his upper right incisor when he was 1½ years old. He had three general anesthetics in the following nine months for dental surgeries: the first surgery to place a cap on the fractured tooth, the second surgery to extract the tooth because it died, and a third surgery to place a prosthetic incisor to replace the lost tooth. These three surgeries were performed in 1998 and 1999 when my son was between 1½ and 3 years of age. He suffered no apparent developmental delays secondary to anesthesia, but in the present day, following the FDA statement, both the physicians and the parents would be unlikely to proceed with three repeated anesthetics on such a young child.
The answer for you depends on whether your child’s surgery is elective and can wait until he or she is 3 years old, whether it is a one-time surgery, whether the surgery is brief, whether it is an emergency or whether it is to remedy a congenital deformity and can not be delayed. You’ll need to have an informed consent discussion with the surgeon, the physician anesthesiologist, and perhaps your pediatrician. If your child’s surgery is a one-time anesthetic for a common short procedure such as ear ventilation tubes or an inguinal hernia repair, it’s likely that proceeding with anesthesia and surgery will be the correct answer. If the surgery is urgent or if delaying surgery will cause an adverse outcome, then proceeding with anesthesia and surgery will be the correct answer. Trust your surgeon and physician anesthesiologist as consultants, and you’ll make the correct choice.
Be reassured. The Society for Pediatric Anesthesiology states that “complications are extremely rare. In the United States, the chance (risk) of a healthy child dying or sustaining a severe injury as a result of anesthesia is less than the risk of traveling in a car.”5
- Andropoulos DB, Greene MF. Anesthesia and Developing Brains — Implications of the FDA Warning. N Engl J Med 2017; 376:905-907
- Lescanne E, et al. Pediatric tonsillectomy: clinical practice guidelines. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):264-71.
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Nuanced characterization and crafty details help this debut soar.
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