Pediatric Oral Conscious Sedation: Changes to Come

Recent media attention has focused the public's attention on issues surrounding pediatric oral conscious sedation. Under a law passed in 1998 and taking affect on Jan. 1, 2000, California dentists will be subject to certification and procedural provisions designed to ensure the educational qualification of the provider and the standards under which the procedure is performed. This article discusses the history of concern and regulation regarding sedation of children in the dental office.

On Jan. 20, 1999, the television news show 60 Minutes II broadcast "Going to the Dentist," a segment reporting on the 1997 death of a 3-year-old in a dental office while undergoing general anesthesia.¹ Statements made on this program indicated that since 1991, in the state of California alone, five children had died receiving dental treatment under "anesthesia." Quoting Dr. Peter Hartmann, a member of the Board of Dental Examiners, "We have received testimony ... that possibly for each death, there’s 40 bad scenarios. Something goes wrong, the child maybe becomes paralyzed ... so that’s quite a few children ... getting injured." These statistics would indicate that at least 200 children in California have been injured from dental sedation since 1991. As a result, the Board of Dental Examiners passed tougher laws regulating the use of conscious sedation in children.

History

Jan. 1, 2000, will open a new chapter of office safety requirements for children undergoing dental procedures involving the oral administration of conscious sedation. Under a law passed in 1998, California dentists will soon be subject to certification and procedural provisions designed to ensure the educational qualification of the provider and the standards under which the procedure is performed.

The chronology of state regulation of the dentist’s ability to administer pharmacologic agents for the purpose of patient sedation began in 1979, when the legislature granted statutory authority to the state Board of Dental Examiners to govern dental office general anesthesia. A permitting process was established requiring onsite facility inspection and demonstration of competency. In 1989, the board assumed regulatory control over parenteral conscious sedation with passage of a law creating a similar permitting process. An important exemption was made, however, for drugs administered orally, under the assumption that such agents were somehow inherently safer and not likely to produce the misadventures and catastrophic accidents responsible for patient deaths. In fact, from 1976 to 1984, of the seven dental office deaths of minors associated with general anesthesia and sedation, only one had been associated with oral drug administration.

The fallacy of this argument became evident as the dentist’s use of oral agents, especially for infants and children, increased following passage of the parenteral conscious sedation permitting law. Between 1991 and 1997 the board recorded the dental office deaths of five children. Four of the five were associated with oral conscious sedation.

Acting to prevent such tragedies in the future and prompted by the circumstances surrounding the death of a 4-year-old in Santa Ana, the board in September of 1997 voted to seek authority from the state legislature to regulate oral conscious sedation. Accordingly, an ad hoc committee of the board was established to draft proposed legislation. Sitting on that committee, in addition to members of the Board of Dental Examiners, were representatives from specialty organizations (including pediatric dentistry, oral and maxillofacial surgery, periodontics, and dental anesthesiology), representatives from the California Dental Association, and several dental educators.

It was immediately apparent from committee discussions that while it would be essential to do everything necessary to assure patient safety, it would also be important to consider the effect of legislation on the pediatric patient’s access to care.

Recommendations From Pediatric Dentistry

The California Society of Pediatric Dentists defined some of the issues involved in the proposed regulatory process as follows:

Safety: The safety of infants and children receiving dental treatment is the paramount consideration in proposed regulation of oral sedation. Infants and children may be placed at unnecessary risk of morbidity or mortality under the existing sedation law, which ignores orally administered drugs. The safe and effective use of an oral sedative agent by a dentist to a pediatric patient undergoing dental treatment requires a level of training, expertise, and proficiency that is not currently addressed by regulation and is not adequately provided by predoctoral dental education.

The administration of oral sedative agents to teenagers and adults is quite safe within recommended dosage levels and does not demand new regulation. There exists, in fact, no history of mortality or morbidity associated with oral administration of sedative agents to patients older than 12. However, the administration of oral sedative agents to infants and children requires unique techniques, dosages, and monitoring standards that differ from those employed in older patients.

Access: Once safety is ensured, the issue of access to dental care becomes critical. Legislative remedy should be designed so as to minimally impede the delivery of needed oral health care to infants and children. Unlike health conditions that will not worsen, or, like the flu, will even resolve, dental conditions will deteriorate without intervention. Infants and children, especially, are at risk for spread of this disease. This is a serious health problem that often demands urgent and definitive treatment that cannot be delayed, deferred, or ignored until the child is older. For some children with special needs, increasing age will make no difference in their ability to withstand or tolerate treatment without pharmacological assistance.

Infants, some children, and those individuals with special health and developmental needs may be unable to receive required dental treatment under normal office conditions. These patients must have the widest possible access to general anesthesia, parenteral conscious sedation, and oral conscious sedation techniques. Regulation should not be so unduly restrictive that it results in a lack of access to care for those most in need.

Whatever regulatory control is recommended and adopted should be the least intrusive and intimidating to the practitioner, while still accomplishing the objective of increasing patient safety. Legislation that unnecessarily discourages practitioners from providing care for which they are trained and capable will impede the delivery of health services necessary for comfort and the oral well-being of children.

Role of education, training and expertise: Examination of those few incidents associated with pediatric oral conscious sedation indicates that almost all are the result of errors of procedure or judgment largely avoidable with proper education and training and strict adherence to recognized guidelines for the safe administration of sedative agents. As long ago as 1983, The Dentists Insurance Company, in a retrospective study of deaths and morbidity in dental practices during a three-year period, concluded that in most of those incidents related to the administration of drugs, there were three common factors:

* Improper preoperative evaluation of the patient;

* Lack of knowledge of drug pharmacology by the doctor; and

* Lack of adequate monitoring during the procedure. ²

Pediatric dentists, like their counterparts in oral surgery and periodontics, are carefully and thoroughly trained in the safe administration of conscious sedation as part of their advanced education programs, lasting two to three years beyond the dental degree. In addition, some general practice residency programs provide advanced education in conscious sedation techniques. Additional education and training, combined with appropriate and documented experience, should be taken into consideration when formulating regulatory legislation.

Operating under the American Academy of Pediatric Dentistry’s Guidelines for the Elective Use of Pharmacologic Conscious Sedation and Deep Sedation in Pediatric Dental Patients, dentists have an excellent safety record utilizing sedation procedures.³ Whatever regulations are adopted should be consistent with these guidelines and those of the American Dental Association.⁴

The committee’s deliberations were not easy, with the debate at times rancorous. Consideration was given to merely removing the existing exemption for oral sedation and placing all conscious sedation into the parenteral conscious sedation permit. Others argued for a separate oral conscious sedation permit, with requirements similar to those of general anesthesia and parenteral conscious sedation. Ultimately, an innovative solution emerged recognizing educational qualification and compliance with recognized standards of care as the keystones to patient safety.

Assembly Bill 2006

Following approval by the Board of Dental Examiners in January of 1998, the proposed pediatric oral conscious sedation statute was introduced in the state legislature by Assemblyman Fred Keeley (D-Boulder Creek) as Assembly Bill 2006. Co-sponsored by the board and California Dental Association, the bill was signed into law by then-Gov. Pete Wilson in September 1998. The measure, which took effect Jan. 1, 1999, grants the Board of Dental Examiners the legal authority, for the first time in California history, to govern a dentist’s conduct in the administration of oral sedative agents to minors younger than 13. Unlike the existing general anesthesia and parenteral conscious sedation permits, the new law specifies a certification process governed initially by educational qualification and later by continuing education. Dentists holding the certificate will have to comply with new sections of the Dental Practice Act concerning the presence of the dentist, the physical evaluation of the patient, record keeping, and equipment and monitoring standards.

AB 2006 requires that after Dec. 31,1999, no dentist in California shall administer or order the administration of oral sedative agents to a dental patient younger than 13 unless the dentist holds either a general anesthesia permit, a parenteral conscious sedation permit, or has been issued a pediatric oral conscious sedation certificate. The law is very specific in its definition of oral conscious sedation, written in statute as a "minimally depressed level of consciousness produced by oral medication that retains the patient’s ability to maintain independently and continuously an airway, and respond appropriately to physical stimulation and verbal command."⁵ Dentists who administer sedative agents that take a minor patient beyond this level (e.g., level 3 or 4 in the American Academy of Pediatric Dentistry’s Guidelines³), intentionally or inadvertently, are required to possess the parenteral conscious sedation or general anesthesia permit regardless of route of administration.

AB 2006 provides two routes by which the dentist may qualify for the issuance of the oral conscious sedation certificate. The first is by educational qualification and the second is by demonstration of prior experience and competence.

The educational qualification may be met by one of the following:

* Satisfactory completion of an accredited program in oral and maxillofacial surgery, pediatric dentistry, or periodontics;

* Satisfactory completion of a general practice residency or other advanced education program meeting Board of Dental Examiners’ standards for sedation training;

* Satisfactory completion of a board-approved program in oral medications and sedation of minor dental patients. (Regulations governing board-approved courses were expected to be adopted in August and should be in place by the publication date of this paper).

Demonstration of prior experience and competence may be met by submission of 10 cases of oral conscious sedation of a minor dental patient completed by the applicant prior to Aug. 31, 1998, documenting satisfactory performance as defined by set criteria.

(At the time of this writing, those criteria were under development by an expert advisory panel to the Board of Dental Examiners). Required documentation for pediatric oral conscious sedation patients is listed in Table 1.

Once the pediatric oral conscious sedation certificate is obtained, the certificate holder will be required to complete a minimum of seven hours of study in each biannual license renewal period as a condition for certification renewal. These seven hours of continuing education in board-approved courses will be applicable to the board’s continuing education requirements for general licensure.

Epilogue

In the July 1999 issue of Redbook magazine, a report titled "The deadly risk your dentist may take" queried "Could a relatively simple dental procedure leave your child brain damaged – or worse?"⁶ The article concluded with five questions that should be asked by parents of any doctor (physician or dentist) contemplating the use of sedation on a child. They are:

* Are you planning to sedate my child?

* Who will monitor my child while the dentist works on his teeth?

* What kind of monitoring equipment do you use?

* Are you and your assistants trained in resuscitation? and

* Will you continue to monitor my child after the procedure, until the drug has completely worn off?

Increased public awareness of a potential problem, in addition to increased regulation of the profession in this very important area can only serve to increase the safety of pediatric oral conscious sedation.

Emphasizing the importance of this proposed regulation, on Sept. 15, 1999, a 3-year-old child died in a California dental office. Although at the time of this writing much information needs to be reviewed before a definitive cause of death can be attributed, the child received an oral sedative for premedication.⁷

Authors/

Stanley F. Malamed, DDS, is a professor and chair of the Anesthesia and Medicine Section of the University of Southern California School of Dentistry.