PEDIATRICS Vol. 108 No. 4 October 2001, pp. 1006-1008

COMMENTARY:
Sedation, Risk, and Safety: Do We Really Have Data at Last?

The July 2001 issue of Pediatrics contained a commentary by Freeman entitled "The Risk of Sedation for Electroencephalograms: Data at Last."¹ This commentary, written to accompany a paper by Olson et al,² made several statements based on erroneous statistical inference. We are grateful to the editors of Pediatrics for granting us this forum in which to respond to that commentary. The great importance of safety for children who need sedation is clearly reflected in past publications of this journal, most notably the American Academy of Pediatrics (AAP) "Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures."³

We, as did Dr Freeman, commend Olson and colleagues for demonstrating that sedation for electroencephalograms (EEGs) in children is usually not necessary when effective behavioral techniques are employed. Nevertheless, there are occasions when behavioral techniques are inadequate, as demonstrated by the 513 patients (18% of the total in this series) who received sedation with chloral hydrate and other drugs. Three of these patients developed oxygen desaturation to between 82% and 88%. This corresponds to a PaO₂ of about 45 to 55, a significant degree of hypoxemia. Although transient hypoxemia is unlikely to lead to long-term consequences, unrecognized or inadequately treated hypoxemia, especially when related to airway obstruction, may progress to more severe complications. It is to the investigators' credit that their compliance with the AAP guidelines for monitoring during sedation resulted in prompt recognition and treatment of the airway problems without sequelae. This ability to rescue from complications is strongly emphasized in the 2001 standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).⁴

Dr Freeman asserts that because these hypoxic episodes occurred in children with risks for airway problems, one cannot ascribe the desaturation episodes to the chloral hydrate. There is no evidence whatsoever to support this contention, nor to support the implication that because these children might have desaturation episodes during natural sleep that chloral hydrate poses no additional risk. Pharmacologically induced loss of consciousness is not the same as natural sleep. We contend that these events further emphasize the need for adherence to the monitoring guidelines, because not all children at risk are readily identified prospectively. Furthermore, a major requirement of the AAP guidelines is to obtain a careful history and physical examination with particular attention to the airway and issues of ventilatory control. Without requirements to follow such guidelines for presedation screening, the recognition of children at increased risk for sedation complications may not occur until airway obstruction ensues after the administration of sedation.

A classic article published in the Journal of the American Medical Association nearly 20 years ago was entitled "If Nothing Goes Wrong, is Everything All Right?"⁵ Its authors discuss the inability to infer safety from investigations in which there were no complications. In Olson's study, in which 513 patients received sedation, it is not surprising that serious adverse outcomes were not detectedthe incidence of these events is likely to be in the magnitude of <1 per 10 000. The Olson study clearly lacks the statistical power to draw any conclusions regarding safety. It seems that the authors, and Dr Freeman, fell into the trap of a type II statistical error. Dr Freeman dramatically compounds the erroneous conclusion that sedation is "safe" when he further questions whether "a qualified and credentialed individual is needed at whatever level of sedation or anesthesia is achieved, either intentionally or unintentionally." This statement, which belies all credulity, was not even a hypothesis advanced in the study in question. One wonders what the outcome might have been in the patients who developed airway obstruction, had properly trained and skilled nursing and medical personnel not been present to detect and intervene in those events. The study by Coté et al, which Freeman dismisses because there is no denominator, did not intend to describe the incidence of sedation complications, but rather analyzed the characteristics of certain practices common to those events.⁶ In that study, practices similar to those that Dr Freeman seems to advocate were identified as having a high risk of complications. The suggestion that an EEG technician, with no medical training or certification, can be relied on to effectively recognize and treat airway obstruction, hypoventilation, and hypoxemia, or that a pulse oximeter is an effective substitute for a qualified and vigilant clinician is, we believe, a recipe for disaster.

It is important to comment on the authorship, intent, and implications of the "Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation" promulgated by the Committee on Drugs of the AAP.³ These guidelines were developed by a multidisciplinary group of pediatric specialists, and included only 1 anesthesiologist out of the 18 authors listed on the document. These guidelines, and the 2001 JCAHO standards,⁴ were not designed to increase cost or create roadblocks for clinical care. They were written to address the problem of iatrogenic injury and medical error by using a systems approach, in which high-risk techniques are identified and avoided, and replaced with alternative strategies designed to minimize risk while maximizing efficacy. In other industries, such as aviation and nuclear power, such an approach has effectively decreased error by orders of magnitude. A recent Institute of Medicine report has clearly made these goals a priority for the medical profession.⁷ Last year's report, "To Err Is Human: Building a Safer Health Care System," indicated that medical errors are symptoms of a dysfunctional systemthe majority of medical errors do not result from individual recklessness, but from basic flaws in the way a health system is organized.⁸ Dr Freeman would have us continue to use dysfunctional systems that will eventually fail, resulting inevitably in death or other catastrophic outcomes. To begin this process, we must examine the acceptable rate of error in any system and "design in" safety mechanisms in our routine practices. Certainly, the issues of cost, reimbursement, and resource allocation are factors in establishing these systems, but patient safety must always remain the foremost objective.

The proposition advanced by Dr Freeman that anesthesiologists have a conflict of interest in developing or disseminating guidelines for the safe conduct of sedation is both insulting and unfounded. The Institute of Medicine report specifically acknowledged the specialty of anesthesiology as being a pioneer in the field of patient safety. The authors note that "anesthesia is an area in which very impressive improvements in safety have been made ... anesthesiology has successfully reduced anesthesia mortality rates from 2 deaths per 10 000 anesthetics administered to 1 death per 200 000."⁸ Pediatric anesthesiologists are pediatric specialists (indeed, many of us are also pediatricians) whose concern is the safety and welfare of pediatric patients. As anesthesiologists, we are recognized experts in the provision of sedation and the monitoring and care of infants and children who have received drugs that alter consciousness. We have no interest in providing anesthesia services to patients receiving EEGs, nor are we aware of any anesthesia service that does so routinely. Our objective is not any professional, financial, or personal gain from the use of safe techniques for caring for sedated infants and children; it is the desire to see that the inherent risks in those procedures have been minimized as much as possible. The adversarial role into which Dr Freeman appears to thrust us is one we vehemently rejectwe are your colleagues, working toward the same goals of child health and advocacy.

We recognize that a commentary is by its nature a statement of opinion, but nevertheless believe that the commentary by Freeman reflects an outdated approach to sedation in children that is no longer "state of the art" or even acceptable. Continuing to do things in the way they have been done in the past does not necessarily serve the interests of children, who deserve better. Great progress has been made in the past 15 years in increasing the safety of sedation care for children, much of it spearheaded by the AAP, and often with the assistance of anesthesiologists who specialize in the care of children. This is not the time to reverse that trend.

David M. Polaner, MD, FAAP
Children's Hospital and University of Colorado Health Sciences Center
Denver, CO 80218

Constance S. Houck, MD, FAAP
Mark A. Rockoff, MD, FAAP
Thomas J. Mancuso, MD, FAAP
Children's Hospital
Boston, MA 02115

G. Allen Finley, MD, FRCPC
Dalhousie University
Halifax, Nova Scotia, Canada

Lynne G. Maxwell, MD, FAAP
Johns Hopkins University School of Medicine
Baltimore, MD 21287

Joseph Cravero, MD, FAAP
Children's Hospital at Dartmouth
Lebanon, NH 03756

Zeev N. Kain, MD, FAAP
Charlotte Bell, MD, FAAP
Yale University School of Medicine
New Haven, CT 06820

Adrian Bosenberg, MB ChB, FFA(SA)
University Natal
Durban, South Africa

Maurice Zwass, MD, FAAP
University of California, San Francisco
San Francisco, CA 94143

Robert Valley, MD, FAAP
University of North Carolina, Chapel Hill
Chapel Hill, NC 27514

Rita Agarwal, MD, FAAP
Children's Hospital
Denver, CO 80218

Anne Savarese, MD, FAAP
University of Maryland
Baltimore, MD 21201

Linda Jo Rice, MD, FAAP
All Children's Hospital
St Petersburg, FL 33701

Charles J. Coté, MD, FAAP
Children's Memorial Hospital
Chicago, IL 60614-3318

Patricia J. Davidson, MD, FAAP
AAP Section on Anesthesiology and Pain Medicine

Lynne R. Ferrari, MD, FAAP
AAP Section on Anesthesiology and Pain Medicine

Peter J. Davis, MD, FAAP
Society for Pediatric Anesthesia

FOOTNOTES

Received for publication Jul 23, 2001; accepted Jul 25, 2001.

Address correspondence to David M. Polaner, MD, FAAP, University of Colorado School of Medicine, Children's Hospital, Department of Anesthesia, 1056 E 19th Ave, B090, Denver, CO 80218. E-mail: polaner.david{at}tchden.org

ABBREVIATIONS

AAP, American Academy of Pediatrics; EEG, electroencephalogram; JCAHO, Joint Commission on Accreditation of Healthcare Organizations.

REFERENCES

1. Freeman JM The risks of sedation for electroencephalograms: data at last. Pediatrics 2001; 108:178 [Free Full Text]
2. Olson DM, Sheehan MG, Thompson W, Hall PT, Hahn J Sedation of children for electroencephalograms. Pediatrics 2001; 108:163-165 [Abstract/Free Full Text]
3. American Academy of Pediatrics, Committee on Drugs Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 1992; 89:1110-1115 [Abstract/Free Full Text]
4. Revisions to Anesthesia Care Standards Comprehensive Accreditation Manual for Hospitals Effective January 1, 2001. Standards and Intents for Sedation and Anesthesia Care. Available at: http://www.jcaho.org/standards/stds2001_mpfrm.html
5. Hanley JA, Lippman-Hand A If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA 1983; 249:1743-1745 [Abstract/Free Full Text]
6. Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics 2000; 105:805-814 [Abstract/Free Full Text]
7. Richardson WC, Berwick DM, Bisgard JC, et al. The Institute of Medicine Report on Medical Errors: misunderstanding can do harm. Quality of Health Care in America Committee. Med Gen Med. 2000(September 19):e42
8. Kohn LT and the Committee on Quality of Health Care in America. Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999