Recent deaths of pediatric sedation patients have prompted revised guidelines for patient safety. A joint position paper from the American Academy of Pediatric Dentistry (AAPD) and the American Academy of Pediatrics (AAP) provides updated safety protocols. The full report may be accessed in the June 2019 issue of Pediatrics.
Updated guidance includes having a minimum of two personnel with specific training and credentialing always present with the pediatric patient undergoing deep sedation or general anesthesia in a dental facility or hospital/surgicenter.
In these clinical settings, an independent observer staff person must remain with the patient. These specific personnel must be skilled to assist with any potential medical emergency. Both this independent observer and operating dentist are required to be certified in Pediatric Advanced Life Support (PALS), as obviously the anesthesiologist is.
From the time of initial anesthesia delivery, continuing through the entire phase of anesthesia and clinical treatment, and throughout the patient’s time in recovery, this independent anesthesia practitioner would remain committed to continual patient observation. This person wouldn’t bounce from treatment room to treatment room, assisting other patients, nor would this person assist the front desk office staff with incoming phone calls. The observer would be solely committed to remaining with the assigned anesthesia patient.
Support in the Pediatric Dental Community
“The guideline is evidence-based, and its intent is to guide practitioners, both dental and medical, in safe and effective sedation of children,” said Monica Fairchild, executive secretary of the Texas Academy of Pediatric Dentistry (TAPD). “TAPD encourages the use of the AAP/ AAPD’s joint sedation guideline when sedating children.”
“I have been a pediatric dentist for over 30 years, and the most important aspect I keep in mind when I treat my patients is their safety,” said John L. Gibbons, DMD, public policy advocate for the Washington State Academy of Pediatric Dentistry.
“The recently revised AAPD/AAP sedation guidelines clarify that when a child is undergoing dental treatment while under deep sedation or a general anesthesia that the sedation be administered by a qualified anesthesia provider with a separate provider performing the dental treatment,” said Gibbons.
“The guidelines go on to specify the qualifications that each of those providers should have. Having two qualified individuals involved in deep sedations or general anesthesia is all about increasing the safety of our pediatric patients,” Gibbons said.
Gibbons emphasized how most pediatric dental specialists have been complying well in advance of recent guidelines.
“Most pediatric dentists I know were already following the clarification made in these revised guidelines. In Washington State where I practice, we go one step further. In Washington, it is required that there is a written contract between the dental provider and the anesthesia provider that goes over the roles each will play with our sedated patients,” said Gibbons.
“However, more important than this written contract is the importance of having an open discussion with the anesthesia provider about our roles in keeping our patients safe,” Gibbons said. “Always, our goal should be to treat our patients in the safest environment possible.”
Paul S. Casamassimo, DDS, MS, who has served as director of the AAPD Pediatric Oral Health Research and Policy Center since November 2011, views these guidelines as a continuum of evolving safety protocols in serving the needs of child patients.
“These are a next step forward. Improvement in sedation safety is incremental. I was involved in this initially in the early 2000s as a member of the AAP/AAPD small group and now as the AAPD chief policy officer and member of the AAPD’s Safety Committee. I have had input into this document but am a small fish at best,” said Casamassimo.
“The biggest changes go to improve pre-op diagnoses/assessment, but, more importantly, saving kids when things go south. This is reflected in the training and number of people in the room,” said Casamassimo.
“The discussions get complex as we continue to try to deal with both medical and dental pediatric sedation and the advocacy and interests of several dental and medical groups. As you might guess, these questions came down to single-word debates, based on positions of groups, often,” said Casamassimo.
Casamassimo stressed that patient interests were always placed to the fore.
“I am pleased to say that in all these deliberations, the welfare of children won out. When a question of professional interest versus a clear or intended safety-related change came up, the groups agreed to choose safety. That’s a tribute to the organizations that must sign off on this as well as the people who worked long and hard to make these meaningful advances and to advocate for children,” said Casamassimo.
Casamassimo stressed two themes for this critical progress in childhood sedation safety. First, the groups agreed that the guidelines will need constant re-evaluation as data comes in. Second, they agreed that the guidelines need to be followed by training programs as well as by providers of such training.
“In our pediatric dentistry training program, we use these guidelines as the roadmap, as do our physician colleagues at the hospital,” said Casamassimo.
“Pediatric dentists by and large are trying to follow these guidelines. The AAPD has for three decades placed patient welfare ahead of provider welfare and is deeply invested in these guidelines and their constant renewal with emerging innovations and data. The same can be said for the other groups in medicine and dentistry who have worked on this,” said Casamassimo.
Casamassimo also serves the Ohio State Dental Board with facility inspections for sedation certification.
“What I have encountered is front-end readiness in terms of patient assessment and drug knowledge. What remains a little iffy is the preparedness of offices to deal with emergencies,” said Casamassimo.
“It is not unusual for me to encounter offices where the dentist and staff are ill-prepared to deal with respiratory distress or drug overdose. It has not been unusual to find the rescue oxygen apparatus in pieces, in a trash bag in a closet, and to find that neither the dentist nor the designated assistant can put it together if it is in pieces. I do not think this is unique to Ohio,” Casamassimo said.
“The other concern I have with sedation is the naive reliance on rescue drugs in an emergency kit. Cases of death over the years have implicated the blind use of rescue medication by untrained and inexperienced dentists. The latest deaths have found that the rescue oxygen tanks have been empty in some cases!” Casamassimo said.
“In others, dentists have tried drug after drug to resuscitate patients, probably in a panic. The best drug is oxygen, and the best rescue action is to call 911 ASAP,” Casamassimo said.
State Dental Boards
Many state dental regulatory boards assume their responsibility of sedation facility inspection and certification as well as provider oversight with great diligence. This not only occurs in Ohio, but also in numbers of states inclusive of Virginia, Kentucky, and North Carolina.
Inspections and certifications generally include both sedation providers and, very importantly, sedation operatory facilities. Issues addressed include but are not limited to oxygen delivery systems, recovery room area, airway management supplies and equipment, monitoring and diagnostic equipment, thorough medical history and physical evaluation records, emergency management supplies and equipment, maintaining thorough anesthesia and sedation records, crash cart setup with emergency meds, patient informed consent records and post-op discharge instructions, demonstration of safe administration of sedation meds, required numbers of properly skilled and certified staff onsite, proper patient monitoring of vital signs, appropriate sedation monitoring, and protocols for reporting of adverse events.
Arizona State Board of Dental Examiners
The Arizona State Board of Dental Examiners came to the attention of the national media for its failure to protect the public welfare over dental sedation. Dr. Pankaj Goyal, a licensed Arizona dentist and dental anesthesiologist, was recently convicted on criminal felony counts for forgery of his anesthesiology credentialing. The state dental board had been warned multiple times over many years of his dubious credentialing, yet it repeatedly ignored these warnings.
Another disturbing case involved the death of a pediatric dental patient in Yuma, Arizona. A two-year-old boy died allegedly subsequent to dental sedation in a corporate chain dental clinic. Allegedly, the facility lacked a functional pulse oximeter, properly trained and certified auxiliary personnel, and a functioning oxygen tank. Also, the dental anesthesiologist was occupied with multiple patients simultaneously, and the child was isolated without monitoring in recovery.
The dental anesthesiologist has subsequently entered into a consent agreement with the state dental board. Additional findings include a failure to properly record the course of anesthesia, a failure to record patient blood pressure and pulse oximeter readings, and a failure to properly handle the sedation of another patient simultaneous with the emergency of the two-year-old boy.
The apparently negligent parties omitted from regulatory oversight were the dental service organization (DSO) and beneficial clinic ownership, a private equity company. These entities controlled clinic staffing and credentialing, facility supplies, equipment and maintenance, staff training, setup of the recovery room, and patient scheduling. But the state elected to refrain from proper regulatory oversight of the facility and of those in control of the sedation facility. Subsequently, the Arizona governor forced the executive director of the state’s dental board into early retirement.
Mississippi State Board of Dental Examiners
More recently, allegations have arisen that DSOs in Mississippi are abusing dental Medicaid children and risking their safety to maximize profits. Allegedly, dental sedation is delivered at corporate dental facilities that lack necessary sedation safety protocols, equipment, supplies, and training. A concerned group of medical anesthesiologists, oral maxillofacial surgeons, and pediatric dental specialists have stepped forward to raise an alarm.
A letter from a medical anesthesiologist to the executive director of the dental board outlined many of these safety and patient’s rights concerns. Following the anesthesiologist’s letter to the state dental board, the DSO filed a lawsuit against the physician for allegations of defamation (Mississippi Smiles Dentistry, LLC, Happy Smiles Dentistry, LLC, et al vs. Matthias, Hinds County Circuit Court MS-First Judicial District, Case# 25CI1:19-cv-00304-EPF, filed 5-14-2019).
Concurrently, this DSO is embroiled in a running social media battle with a mother from Gulfport, Mississippi, who claims her autistic child was harmed due to sedation treatment from this pediatric dental clinic chain. Allegedly, clinic staff retained by the DSO also violated federal HIPAA statutes by engaging in open public commentary on a child’s treatment. The DSO’s management denies any breach of patient confidentiality.
The pediatric specialist dental and medical communities are correct. The anesthesiology specialty community is correct. Casamassimo and Gibbons are correct. The patient’s welfare and safety must always come first.
Concerns over sedation economic costs cannot and should not continue to generate additional needless childhood morbidity and mortality. Esteemed, ethical, and learned healthcare specialty professionals have established sedation guidelines to serve the greater good. Their efforts are not static but ongoing as advancements are discovered and implemented.
The most vulnerable population for dental sedation abuses is the dental pediatric Medicaid demographic. Too many DSOs and private equity firms have viewed this group as a financial cash cow. Compounding the problem has been an historic lack of regulatory oversight and enforcement by certain state dental boards.
The rich and powerful can only milk the dental Medicaid cow for so long, at the expense of disadvantaged children and taxpayers. Eventually the cow runs dry, and the Medicaid program collapses, or caring professionals stand up for the public welfare to stop a needless slaughtering of children.