Informed Consent: Sedation Risks in Children Younger Than 3 Years

A recent review (DS Fishman, DB Andropoulos, JR Lightdale. JPGN 2019; 69: 3-5) discusses the topic of sedation and an FDA warning from 2016 that should be familiar to pediatric GI physicians. Related blog post (2017): FDA Warning Anesthesia and Developing Brains

The medications which induce an ‘anesthetic state’ may cause cell death and may be “causing some degree of irreversible cellular injury –at least in developing brains, which are particularly vulnerable to apoptosis… [which leads to the] sobering thought that …sedatives could be associated with long-term neurological effects.”  At the same time, the authors caution of the potential for the warnings to cause “a delay in the care of the patient.”  The authors advocate the following talking points:

  • “A single short exposure (~60 minutes) does not appear to cause adverse neurodevelopmental outcomes”
  • “There is some evidence that longer (>3 hours) or repeated exposure could have negative effects on behavior or learning.”

Websites for physicians and families:

My take: These FDA warnings need to be taken seriously and low yield/low value endoscopy needs to be avoided.

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Park Guell, Barcelona

FDA Warning: Anesthesia and Developing Brains

A good review on the issue of anesthesia and the developing brain: DB Andropoulos, MF Greene. NEJM 2017; 376: 905-7.

The authors from Texas Children’s Hospital comment on the prior studies and how their approach has changed since the FDA on December 14, 2016 issued a “Drug Safety Communication” (www.fda.gov/Drugs/DrugSafety/ucm532356.htm).  The FDa warning targets anesthesia in children less than 3 yrs of age and pregnant women in the 3rd trimester who undergo anesthesia for >3 hrs.

At Texas Children’s, the authors state that the FDA warning is now discussed with parents of all children younger than 3 yrs receiving an anesthetic. The authors, however, worry that the “FDA warning will cause delays for necessary surgical and diagnostic procedures.”

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Academic Performance After Anesthesia

A new study provides some reassurance that anesthesia at a young age is unlikely to cause harm (little to no effect) in most children.

Full text: P Glatz et al. JAMA Pediatrics, Published online November 7, 2016. doi:10.1001/jamapediatrics.2016.3470: Association of Anesthesia and Surgery During Childhood with Long-Term Academic Performance

Findings  In this cohort study among 33 514 exposed children, exposure to surgery with anesthesia before age 4 years was associated with 0.41% lower school grades and 0.97% lower IQ test scores, with no difference in school grades with regard to age. The overall difference was markedly less than the differences associated with sex, maternal educational level, or month of birth during the same year.

Comment: Despite efforts to control for indications which of themselves could impact the results, it is quite possible that the small changes detected in this study are a result of confounding factors rather than due to the anesthetic itself.

My take (from the authors): “Exposure to anesthesia and surgery before age 4 years is associated with a small difference in academic performance or cognitive performance in adolescence on a population level. The magnitude of this association should be interpreted in light of potential adverse effects of postponing surgery.”

Related blog post: More evidence of anesthetic neurotoxicity

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