Letters to the Editor

Pediatric intensivists provide a unique skill set and expertise that is needed at the bedside to provide optimal patient care. It is possible that the benefit for specific patients will be difficult to quantify in large-scale investigations. However, as with any limited resource, individual institutions must consider all factors in designing coverage models to have pediatric intensivists at the bedside when needed. Coverage models must place patient care foremost but must also be sustainable, financially viable, and allow for optimal education of housestaff and career development for faculty. In an era where standardization and consistency are becoming increasingly important, until we can better define the features of in-house coverage that benefit patients, we will need to accept that “one size does not fit all.” Dr. Cheifetz consulted for Philips, Hill-Rom, and Teleflex and provided expert testimony for various entities. His institution received grant support from Philips, CareFusion, Teleflex, Covidien, and Ikaria. The remaining authors have disclosed that they do not have any potential conflicts of interest. Kyle J. Rehder, MD, FCCP, Ira M. Cheifetz, MD, FCCM, David A. Turner, MD, Division of Pediatric Critical Care, Duke Children’s Hospital, Durham, NC

REFERENCES

1. Spentzas T: Should I Stay or Should I Go? Pediatr Crit Care Med 2014; 15:575–576 2. Rehder KJ, Cheifetz IM, Markovitz BP, et al: Survey of in-house coverage by pediatric intensivists: Characterization of 24/7 in-hospital pediatric critical care faculty coverage. Pediatr Crit Care Med 2014; 15:97–104 3. Rehder KJ, Cheifetz IM, Willson DF, et al; Pediatric Acute Lung Injury and Sepsis Investigators Network: Perceptions of 24/7 in-hospital intensivist coverage on pediatric housestaff education. Pediatrics 2014; 133:88–95 4. Burnham EL: 24/7 attendings: “Helicoptering” the housestaff? Pediatrics 2014; 133:131–133 5. Ackerman AD: A chicken in every pot—A pediatric intensivist in every unit/all the time? Pediatr Crit Care Med 2014; 15:170–171 DOI: 10.1097/PCC.0000000000000141

Proving Propofol “Safe” for Continuous Sedation in the PICU Is an Impossible Task To the Editor:

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n a recent issue of Pediatric Critical Care Medicine, Koriyama et al (1) report their experience using propofol infusions in 210 patients in their PICU. They report no instances of propofol infusion syndrome (PRIS) and imply the drug is “safe.” Hauser and Bell (2) add in an editorial that we should have equipoise by now for a large controlled trial. PRIS exists. Given the medicolegal implications of a patient dying from a drug that is specifically contraindicated for this purpose by the manufacturer with a “black box” warning, it is unlikely we will have seen case reports in the literature of recent instances. How reassured should we be by zero cases of PRIS in the report by Koriyama et al? I refer to the classic report by Hanley Pediatric Critical Care Medicine

and Lippman-Hand (3): “If nothing goes wrong, is everything all right?” With the rule of thumb that the upper 95% CI for the number of adverse events being 3/n, we can be reasonably confident that the prevalence of PRIS is not higher than 1.5% from this report. Multiply that 1.5% by the thousands of children who might receive propofol with a newly reassured population of pediatric intensivists, and scores of children might die around the world from this drug’s use. Would a controlled trial help determine the risk better? If we wanted to be 95% confident that the prevalence of PRIS is less than, say, 3 per 1,000, we would need 1,000 children (in the active drug arm!) to draw this conclusion. Even 3 per 1,000 would mean children would needlessly die of an avoidable cause. What is an acceptable risk in giving a drug for which there is no absolute indication? The opportunity to prove propofol “safe” for continuous sedation in the PICU is over and an attempt at a trial would be futile. Perhaps a better way to truly assess the safety of this drug would be the creation of a detailed registry, where dosing, duration, demographics, and other data could be collected and outcomes determined. (Of course, this assumes that every case of propofol use at participating institutions would be entered, including those with complications, such as PRIS.) However, as noted, we would likely need upwards of 10,000 patients to determine a true prevalence of this rare, fatal, and avoidable condition. The author has disclosed that he does not have any potential conflicts of interest. Barry P. Markovitz, MD, MPH, Division of Critical Care Medicine, Children’s Hospital Los Angeles, Los Angeles, CA, and Department of Anesthesiology and Pediatrics, USC Keck School of Medicine, Los Angeles, CA

REFERENCES

1. Koriyama H, Duff JP, Guerra GG, et al; Sedation Withdrawal and Analgesia Team: Is Propofol a Friend or a Foe of the Pediatric Intensivist? Description of Propofol Use in a PICU. Pediatr Crit Care Med 2014; 15:e66–e71 2. Hauser GJ, Bell KG: Prolonged propofol infusions in critically ill children: Are we ready for a large controlled study? Pediatr Crit Care Med 2014; 15:176–178 3. Hanley JA, Lippman-Hand A: If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983; 249:1743–1745 DOI: 10.1097/PCC.0000000000000142

The author replies:

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thank Dr. Markovitz (1) for his comments and welcome the continuing discussion of this important topic. Markovitz (1) is worried that a large-scale controlled randomized study of propofol infusion in critically ill children would put children at risk for “a drug for which (there) is no absolute indication.” As stated in our editorial (2), almost all cases of the Propofol Infusion Syndrome (PRIS) have been described after prolonged (> 48–72 hr) high-dose (> 4 mg/kg/hr) infusions. www.pccmjournal.org

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