Comment on Growth in an Anesthesiologist and Nurse Anesthetist-Supervised Sedation Nurse Program Using Propofol and Dexmedetomidine

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In the interests of patient safety, the Society for Pediatric Anesthesia believes it is important to comment on the report from Thomas et al1 on the “Growth in an Anesthesiologist- and Nurse Anesthetist-Supervised Sedation Nurse Program Using Propofol and Dexmedetomidine.”1 Although the report is interesting, we have significant concerns related to the model of care and the authors’ conclusions.
The authors describe the use of a registered nurse sedation service supervised by certified registered nurse anethetists (CRNAs) or anesthesiologists. The supervising staff is present for “selected” cases (criteria undisclosed) and registered nurses independently monitor other cases. The sedation protocols include relatively large doses of potent sedatives, including propofol and dexmedetomidine infusion as well as supplemental doses of each, a strategy associated with severe bradycardia in other studies. Additionally, ketamine and midazolam may be added if sedation is deemed inadequate. Given the protocols described, and the sedation level goals, many children in this report were likely deeply sedated or under general anesthesia. Consequently, the practice should be referred to as deep sedation/anesthesia rather than merely sedation.
Of greatest concern to the Society is the conclusion that the nurse sedation model is safe based on their observations. This conclusion is clearly not warranted given the very low expected incidence of major complications associated with anesthesia or sedation, especially within a low-risk population as described in this report. In 2009 and 2015, the Pediatric Sedation Research Consortium (PSRC) published outcomes of 50,0002 and 90,0003 children, respectively, sedated with propofol in which no deaths occurred in children who were on average significantly more complex than those described in this report. With these data in mind, the fact that Thomas et al1 did not report a fatality does not reassure us that this practice is “safe.” This observational report is clearly underpowered to evaluate an outcome with a frequency that would only be expected in a study of 5 to 10 times the size of this one. In fact, comparison of PSRC data with those in this report raises some concerns about the nurse model of care. The frequency of unexpected admission related to sedation/anesthesia care was 0.05% in the PSRC population and nearly 3 times that in the Thomas report. We are sure that, at the very least, the authors would agree that a much larger study is required to make formal conclusions about the safety and efficacy of this model of care.
Much more work is needed to determine the safety of the changes to the care team as suggested in this report.
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