April 1, 2017
The American College of Surgeons (ACS) Advisory Council for Pediatric Surgery developed the following statement, which the ACS Board of Regents approved at its February 2017 meeting in Chicago, IL.
In December 2016, the U.S. Food and Drug Administration (FDA) released a Drug Safety Communication warning that stated repeated or lengthy (greater than three hours) use of general anesthetic or sedation drugs during operations or procedures in children younger than three years of age or in pregnant women during the final trimester may affect neurologic development.*
The potential adverse effects of anesthesia have been studied for years, and to date, no human data support this conclusion. The FDA’s communication is based solely upon animal data, which may or may not pertain to humans.* Some epidemiologic studies have suggested an association between childhood anesthesia exposure, particularly longer duration or repeated exposure, and adverse neurodevelopmental outcomes; however, it remains unclear whether these associations represent an effect of the anesthetic drugs as opposed to the operation itself, underlying patient medical conditions, or other factors.
The ACS would like to remind the public that when a pediatric surgical subspecialist recommends an operation for a child, the preservation of a child’s short- and long-term health and well-being are foundational to this recommendation. Pediatric surgeons understand that when parents are engaged in an informed consent discussion for urgent and emergent procedures, the focus of the discussion will include the known risks of surgery and anesthesia but will necessarily emphasize the need for surgery (and therefore general anesthesia) in the absence of a safe alternative therapy.
However, this FDA communication provides a different perspective for elective procedures. It is the recommendation of the advisory council that the FDA communication be discussed with patients and their families. Health care professionals also need to remind patients and their families that the timing of surgery is critical to an outcome in many instances. Examples of when timing plays a critical role in surgical outcomes include cleft palate surgery, cranial vault surgery, and orchiopexy for undescended testes.
Historically, pediatric surgeons have been at the forefront of practice changes leading to the safe delay or avoidance of surgery and general anesthesia, and the management of solid organ injury and repair of umbilical hernia are two prime examples of this practice. It is assumed that our professional awareness of the theoretical risks associated with general anesthesia will invoke a thoughtful professional debate on other elective surgical procedures that might reasonably be delayed.
The ACS recommends that although an informed discussion based on existing and emerging evidence of the potential adverse effects of repeated general anesthesia in children younger than three years old on neurologic development should take place—and may, in some instances, lead to a decision to delay surgery—it is our responsibility to encourage shared decision making that equally considers the consequences of delaying a time-sensitive operation.
*U.S. Food & Drug Administration (FDA). FDA Drug Safety Communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. December 14, 2016. Available at: www.fda.gov/Drugs/DrugSafety/ucm532356.htm. Accessed February 22, 2017.