Early childhood caries (ECC) is the single most common chronic childhood disease. In the treatment of ECC, children are often given moderate sedation or general anesthesia. An estimated 100 000 to 250 000 pediatric dental sedations are performed annually in the United States. The most common medications are benzodiazepines, opioids, local anesthetics, and nitrous oxide. All are associated with serious adverse events, including hypoxemia, respiratory depression, airway obstruction, and death. There is no mandated reporting of adverse events or deaths, so we don’t know how often these occur. In this article, we present a case of a death after dental anesthesia and ask experts to speculate on how to improve the quality and safety of both the prevention and treatment of ECC.
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December 2017
Ethics Rounds|
December 01 2017
Ethics Rounds: Death After Pediatric Dental Anesthesia: An Avoidable Tragedy?
Helen Lee, MD;
Helen Lee, MD
aDepartment of Anesthesiology, College of Medicine, University of Illinois at Chicago, Chicago, Illinois;
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Peter Milgrom, DDS;
Peter Milgrom, DDS
bDepartments of Oral Health Sciences,
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Colleen E. Huebner, PhD;
Colleen E. Huebner, PhD
cHealth Services, and
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Philip Weinstein, PhD;
Philip Weinstein, PhD
bDepartments of Oral Health Sciences,
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Wylie Burke, MD;
Wylie Burke, MD
dBioethics and Humanities, University of Washington, Seattle, Washington; and
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Erika Blacksher, PhD;
Erika Blacksher, PhD
dBioethics and Humanities, University of Washington, Seattle, Washington; and
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John D. Lantos, MD
ePediatric Bioethics Center, Children’s Mercy Kansas City, Kansas City, Missouri
Address correspondence to John D. Lantos, MD, Pediatric Bioethics Center, Children’s Mercy Kansas City, 2401 Gillham Rd, Kansas City, MO 64108. E-mail: [email protected]
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Address correspondence to John D. Lantos, MD, Pediatric Bioethics Center, Children’s Mercy Kansas City, 2401 Gillham Rd, Kansas City, MO 64108. E-mail: [email protected]
POTENTIAL CONFLICT OF INTEREST: Dr Milgrom is a director of Advantage Silver Dental Arrest, LLC; the other authors have indicated they have no potential conflicts of interest to disclose.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
Pediatrics (2017) 140 (6): e20172370.
Article history
Accepted:
July 17 2017
Citation
Helen Lee, Peter Milgrom, Colleen E. Huebner, Philip Weinstein, Wylie Burke, Erika Blacksher, John D. Lantos; Ethics Rounds: Death After Pediatric Dental Anesthesia: An Avoidable Tragedy?. Pediatrics December 2017; 140 (6): e20172370. 10.1542/peds.2017-2370
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Comments
RE: Ethics Rounds: Death After Pediatric Dental Anesthesia: An Avoidable Tragedy?
Milgrom et al. misstate that association between dental caries lesions in the primary dentition and permanent dentition is the common rationale for surgical treatment of early childhood caries and that the association has been “vastly overstated.” [1] Morbidity and Mortality pyramid associated with early childhood caries provides a better description for the need to treat children with early childhood caries. [2] Contrary to Milgrom et al.’s assertion that exfoliation of carious primary teeth results in resolution of the condition, longitudinal data shows that caries lesions in the primary dentition at five years of age impact upon caries lesions in the permanent dentition at 26 years of age. [3] Dental caries is an infectious disease with longitudinal progression from the primary to the permanent dentitions. Transmission of dental caries susceptibility between the primary and permanent dentitions is highlighted in a site-specific manner by caries association between distal surfaces of primary second molars and mesial surfaces of permanent first molars. [4]
Milgrom et al. misstate that local anesthesia is not required for tooth preparation in primary teeth as these teeth are insensitive disregarding anatomic evidence demonstrating innervation of primary teeth. [5]
References:
1. Lee H, Milgrom P, Huebner CE et al. Ethics rounds: Death after pediatric dental anesthesia: an avoidable tragedy? Pediatrics 2017; 140(6):e20172370.
2. Casamassimo PA, Thikkurissy S, Edelstein BL, Maiorini E. Beyond the dmft – the human and economic cost of early childhood caries. J Am Dent Assoc 2009; 140(6):650-657.
3. Thomson WM, Poulton R, Milne BJ, Caspi A, Broughton JR, Ayers KMS. Socioeconomic inequalities in oral health in childhood and adulthood in a birth cohort. Community Dent Oral Epidemiol 2004; 32(5):345-353.
4. Vanderas AP, Kavvadia K, Papagiannoulis L. Development of caries in permanent first molars adjacent to primary second molars with interproximal caries: Four-year prospective radiographic study. Pediatr Dent 2004; 26(4):362-368.
5. Egan CA, Bishop MA, Hector MP. An immunohistochemical study of the pulpal nerve supply in primary human teeth: evidence for the innervation of deciduous dentine. J Anat 1996; 188(Pt 3):623-631.
Sedation Safety Has Many Perspectives and The Discussion is Ongoing
Dear Dr. Nickman,
We agree that the hypothetical case is not representative of the care provided on a daily basis. Rather, it is meant to represent what happens when many gaps in safety result in an adverse event. Adverse events, while rare, are opportunities to learn and change.
Our intention was to facilitate a discussion about how these adverse events could be framed from the perspectives of dentistry, anesthesiology, and bioethics. However, the perspectives are truly from the individual authors and should not be interpreted to be representative of entire specialties.
Clearly this topic is multi-factorial, spans several disciplines, and encompasses many perspectives. We appreciate the perspective from pediatric dentistry provided in your comments, and the controversial nature of claims about silver diamine fluoride (SDF), which are addressed in a separate response from Dr. Milgrom and colleagues.
As we noted in our commentary, preventive dentistry to reduce the number of children with severe caries is an important part of the solution. However, preventive dentistry and SDF have their limits. Caries etiology is highly influenced by oral health behaviors, which clinical dentistry may have limited ability to affect, particularly when some parents of patients simply do not seek care until their disease is severe. Just as the disease is multifactorial in nature, we believe that improving safety will entail multiple approaches. Prevention is essential, but it involves not just access to pediatric dentistry but also the social commitment to help families with few resources and little experience with dentistry or oral health requirements. Innovative approaches to outreach and education will be needed, together with more general efforts to improve access to healthy foods.
Such approaches should be considered as part of a larger effort to understand how systems of care allow adverse events to occur. These include access to timely and affordable dental care and, when early childhood caries occurs, safe dental procedures. At what point, how many adverse events, must occur before change occurs?
We do not believe that sedation is performed routinely in a cavalier manner. We believe that many people are invested in the safety of children, care about affected families, and sincerely seek meaningful change. We are glad that your comment has expanded and enriched this discussion and hope that this is the beginning of a dialogue that addresses all facets of this important health problem.
Respectfully,
Helen H. Lee
Erika A. Blacksher
Wylie Burke
The Whole Story on Sedation
The recent Ethics Rounds: Death After Pediatric Dental Anesthesia: an Avoidable Tragedy?[1], featuring a hypothetical case scenario of a child death attributed to sedation, is not a true representation of the sedations performed many times daily in this country safely and according to guidelines jointly supported by the American Academies of Pediatrics (AAP) and Pediatric Dentistry (AAPD)[2]. The discussion focuses on caries management rather than anesthesia as stated in the title, and also inaccurately poses an unrealistic set of choices for care of the young child with established dental pain from early childhood caries. We are concerned that the readership of Pediatrics leaves this forum with the belief that sedation for management of caries is an inherently dangerous procedure haphazardly applied by the dental community, or that silver diamine fluoride (SDF) is a panacea for dental pain attributable to severe early childhood caries.
As accurately stated by the authors, early childhood caries is epidemic and with it comes a host of potential short- and long-term consequences. Depending upon the extent and severity of caries, the age and developmental status of the child, his or her cooperation, health status, and parental and dentist choices, a host of treatment options exist to manage this disease. Rarely is the choice simply a dichotomy between sedation and SDF. When a history of pain has been established associated with the condition, SDF is usually not considered, because the infection has spread and it will be ineffective. The consequences of pain on the child, who often endures weeks of it in addition to significant doses of over-the-counter pain medication, and on the often poor parents whose caretaking routine is disrupted, are reasons to go beyond SDF.
The decision to sedate a child is seldom made lightly. The American Dental Association’s Choosing Wisely recommendations, supported by the AAPD, encourage parents to exhaust other options before choosing more advanced behavior guidance, as do the behavior guidance guidelines of the AAPD.
Perhaps the series of errors in sedation protocol described in the case scenario are meant to stimulate discussion, but a serious forum on the ethics of treatment of this epidemic with known consequences beyond the stated effect on permanent teeth would have better described the reality of the rare sedation death, which is its unpredictability. The reality of complication in even the best of circumstances is troublesome and should be the focus of resolve by those invested in child safety. Further, the rounds discussion fails to acknowledge the hundreds and perhaps thousands of sedations safely performed by health professionals following the AAP/AAPD guidelines, which allow treatment of conditions that would otherwise not occur, or be beyond the financial reach of families.
The rounds discussion would have been better to focus on the dilemma of treatment choices that are very real in circumstances such as a child with painful dental caries, developmental behavior challenges for the clinician, limited family resources, and dependency upon a payer industry that has not engaged in a contemporary and epidemic-aware discussion with health professionals and child advocates. As stated by the discussants, medical and dental organizations are actively discussing the issue of sedation deaths of children and what can be done to prevent them.
The goal is no death from sedation for any child and it is achievable. If readers leave this forum believing that SDF is an alternative for other treatment of caries as described in the case scenario, or that sedation is commonly done cavalierly or ineptly, it has done a disservice to children and their families, and to health professionals who take safety seriously.
REFERENCES
[1] Lee H, Milgrom P, Huebner CE, et al. Ethics Rounds: Death After Pediatric Dental Anesthesia: An Avoidable Tragedy? Pediatrics. 2017;140(6): e20172370
[2] Coté CJ, Wilson S. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. American Academy of Pediatric Dentistry, American Academy of Pediatrics. Pediatr Dent 2016;38(4):E13-E39.
RE: A Highly Questionable Article
I was surprised but interested to read this article in Pediatrics this week. There is no doubt that the death of any child during dental treatment under sedation is unacceptable. However,I take issue with both the discussion and the conclusions reached by Drs. Milgrom, Huebner and Weinstein. I invite any or all of the authors to spend ONE day in my office and witness the parade of children who attend for urgent care; children who are in pain and are suffering. To suggest that 'treating tooth decay as illustrated in this case presentation....is unethical and wasteful." is laughable in the extreme and ridiculous posturing on their part. Despite their advanced education, credentials and research records, their conclusion suggests they know little and understand nothing about the real world of pediatric dentistry. Surgical dentistry is very much a necessity and will likely remain so for generations to come. It is neither unethical nor wasteful to provide such care as but ONE COMPONENT of a carefully constructed and executed, multi-faceted treatment plan which has offered alternatives to parents who have provided their informed consent to proceed.
There is no doubt that SDF and ITR have a place in the management of ECC. We offer that alternative to many parents. But it is only one option. For many children, application of SDF to advanced carious lesions, lesions which are causing pain, would be considered supervised professional neglect.
Furthermore, placing glass ionomer in carious lesions without local anesthesia, as they suggest, especially in an uncooperative child takes us back generations in terms of offering compassionate care. This is a recipe for creating dental phobics. Given the excellent publications produced by Drs. Milgrom and Weinstein several decades ago in the area of behaviour management, I am surprised that they would recommend this antiquated approach, an approach most parents today would reject.
It is useful to examine standards of care in other areas of pediatric medicine to observe how painful and invasive treatments are managed. Do ENT surgeons place grommets without general anesthesia when we know that this procedure could be completed under local anesthesia? Of course not. And is this procedure more or less technically demanding than placing an intracoronal or extracoronal restoration on a primary tooth? Anyone who knows both fields knows the answer and it is not placing grommets.
Drs. Weinstein , Milgrom and Huebner would do well to examine the curriculum of both undergraduate and postgraduate dental programs to identify deficiencies in patient management strategies such as sedation and anesthesia. The vast majority of pediatric dental residencies are failing the residents they train in the area of pharmacologic patient management. Few pediatric dental residencies teach anything more than nitrous oxide/oxygen sedation with or without an oral sedative. Yet the evidence is clear that oral sedation has a high failure rate and is the LEAST predictable of all routes of drug administration. And offering nitrous oxide and oxygen sedation for the preschool child with advanced ECC is a recipe for failure. Nitrous oxide and oxygen is a wonderful adjunct FOR THE MODERATELY COOPERATIVE child, but is rarely effective in the preschool child. Moreover, few pediatric dental residencies train residents to work with and use the skills of other advance practice health care providers such as critical care nurses. We, as a specialty, remain ensconced in our silo.
Pediatric medicine, on the other hand, has largely abandoned oral sedation and has embraced parenteral routes of sedative drug administration, intravenous and intranasal being the prime examples. And this is where I take issue with the comments by Dr. Lee. It is the Departments of Anesthesia is virtually every pediatric health care institution in North America that have resisted the call to educate non-anesthesiologists in safe pediatric sedation practices; not just dentists but other medical providers - emergency room physicians, pediatric hospitalists, pediatricians as examples. In fact, many Departments of Anesthesia in pediatric facilities have been uncooperative and obstructionist when approached by groups like pediatric dentists requesting assistance in developing the necessary skills to provide safe pediatric sedation. Yet, pediatric sedation is offered more frequently now than ever before in pediatric health care settings other dentistry. One of the reasons this has occurred is because of the work of a few anesthesiologists who recognized the problem and aimed to improve both education and safety of those sedation providers. Sadly, those anesthesiologists are few and far between. So, point the finger if you must Dr. Lee but recognize that in refusing to engage with your dental colleagues, Anesthesia is also complicit in this issue.
In summary, I agree with the authors that we, in pediatric dentistry, have a problem. We will solve the problem by working together, recognizing that sedation for pediatric dentistry is no different than sedation in the emergency room or in the imaging department and educating and training our residents to meet the same standards of care to uphold patient safety at ALL TIMES.
RE:
Dr. Baghdadi,
Thank you for your comments. There is no question about the need and role for sedation/GA to compassionately treat severe caries in young children; those with behavioral issues; or those with medically complex conditions. I also agree that one of the biggest challenges to improving safety is rooted in the lack of complete data. I tried to make the point that, based upon the sparse information available, there are several possible issues at hand. For some providers, there may be an education or clinical skills issue. For others, creating and maintaining a system of practice that is able to respond to rare events efficiently is a challenge. Safety in the clinical realm is a dynamic process that is linked to the patients, providers, and systems of care. Therefore, when an adverse event occurs, it can be disingenuous to state that adverse events occur from one aspect of care.
However, I still maintain that just because solutions are difficult to identify and implement, it doesn't absolve us from trying. I also believe that identification of the issues and possible interventions require all stakeholders (pediatricians, anesthesia providers, dentists, support staff, and patients) to work together. Everyone I have talked to about this topic--in dentistry, anesthesia, pediatrics, public health-- believes this is important. We each have a common goal, which is patient safety. Let's move forward to understand and implement solutions.
Best,
Helen Lee
RE:
I see some flaws in this commentary paper. While it is true that the AAPD puts more emphasis on prevention and arrestment of the disease processes, the AAPD also acknowledges the need for sedation/GA to treat ECC. In one of its policies/guidelines you read:
The AAPD strongly encourages third-party payors to:
1. Recognize that sedation or general anesthesia is necessary to deliver compassionate, quality oral health care to some infants, children, adolescents, and persons with special health care needs.
Also, there is no enough information to decide on the reasons of death, particularly that sedation was done using oral midazolam, which has relative wide safety margins when the provider uses the correct dosage per kg. Is this due to over-dose? as you can read in page 2 that, "He[the patient] requires as extra dose of midazolam because of his inability to tolerate the procedures".
There were suggestions that this case and similar cases of caries could be managed by SDF (silver diamine fluoride) which the AAPD just very recently has issued its 'conditional' recommendations to use it. You can read in the introduction of the case that the child's mother reports that "the child complains of pain while eating and occasionally wakes up in the night because of tooth pain." Can these signs and symptoms be treated using SDF or Hall technique as suggested by this article's authors?