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• W1566506212 abstract "To the Editor. Coté et al1 have performed a valuable service in their critical analysis of reported adverse sedation events. Some of the pitfalls inherent in this study are pointed out in the accompanying editorial. However, the editorial did not emphasize that once again the authors are combining analysis of patients given either analgesia and sedation—they are studying apples and oranges, and evaluating fruit salad.The Coté study evaluated a selected sample, from a biased cohort, which lacked a denominator. In a larger, differently structured study,2 97.7% of children receiving proper management of sedation and analgesia in an emergency room setting had no adverse events. All of the events that did occur in the remaining 2.3% were transient, minor, and easily managed. Even in that study, sedation and analgesia are combined, and yet every physician, anesthesiologist—and grandmother—knows that sedation and analgesia are different. They are different in the goals sought, they may be different in the medications used, and different in the depth of neurologic alteration desired. They are also probably different in their complications.For years, indeed for generations, chloral hydrate has been used for sedation—to provide sleep and thereby lessen anxiety. Chloral hydrate is not an analgesic. In situations where mild sedation, not analgesia, is desirable, chloral hydrate has been used widely and safely. For example, young children are often anxious about electroencephalograms (EEGs), and sleep is an important state of the brain in which to evaluate epileptic activity. Analgesic medications might even invalidate the EEG study. And yet we are no longer permitted to use chloral hydrate for sedation for EEGs without having a nurse (or physician) in attendance for monitoring. Why?Where are the data on the incidence of adverse events after appropriate doses of chloral hydrate for such sedation? Where are the “critical events analyses” where only chloral hydrate or other medications for conscious sedation are used? In Table 1 of his article, Cotécites 3 examples of such adverse events. He cites 1 child who received 6000 mg of chloral hydrate. Why was the child given such a large dose, and what was the adverse event? A second child was “flown up from Mexico for a cardiology procedure and received 60 mg/kg of chloral hydrate. Depression, bradycardia, and arrest followed …” The implication is that the chloral hydrate caused the event. It is unlikely that the child did not receive other medications for the procedure, whatever it was. What was the role of the digoxin? A third child had an adverse event of unstated type, and “the mother had given 2 prescriptions of chloral hydrate at home.” What was dose? What was the event? What were its consequences?As a result of Coté's work and that of others, children who require EEGs often get inadequate studies, without sleep. They are, for example, often sent away from Johns Hopkins for studies because it is fiscally unsound for us to subsidize a nurse to monitor each child because the additional costs will not be reimbursed by insurance.Have the recommendations of the Academy resulted in safer studies? Where are the data that chloral hydrate properly prescribed for sleep is an unsafe drug? What is the magnitude of the risk to children? How does it compare with the risks of the procedures being performed at other sites? Does the quality of the studies performed elsewhere and their interpretation factor into the cost-effectiveness of the recommended monitoring?Analgesia clearly may require more careful monitoring and more vigorous resuscitation than was done in the past. However, to lump sedation and analgesia together and develop a numerator of adverse events without any denominator is to lump together apples and oranges.We need far better data in both the numerators and in the denominators of the risks of sedation, and separately of analgesia. We need to understand the risk/benefit equation of each before we accept the proscriptions that have been forced on us and the families we serve." @default.
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• W1566506212 title "Adverse Effects of Lotrisone Cream Used in Infants" @default.
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• W1566506212 doi "https://doi.org/10.1542/peds.106.6.1519a" @default.
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