Our March 15, 2016 Patient Safety Tip of the Week “” had an extensive section on the adverse outcomes of pediatric patients receiving sedation. Young children are particularly vulnerable because they are often sedated since they may be uncooperative for dental procedures. Moreover, many such incidents have occurred when a child is restrained by a device called a “papoose”. Proper procedures and guidelines for pediatric sedation were discussed in our August 2016 What's New in the Patient Safety World column “”.
Two events have brought the issue back to our attention. One was the death of another child occurring during sedation for a dental procedure. The other was a proposal from a Texas blue ribbon panel for new recommendations following a series of sedation-related deaths in Texas.
The new case was that of a 4 y.o. boy in Vancouver, WA who died during a routine dental procedure, apparently performed under ketamine sedation/anesthesia (Mehlhaf 2017, Balick 2017). The boy apparently was on the autism spectrum and had difficulty keeping his mouth open. But no other details are available.
The Texas blue ribbon panel (Texas SBDE 2017) made its recommendations after analyzing the Texas cases with adverse events and reviewing the scientific literature, the above mentioned guidelines, and regulations in place in other states. The recommendations include the following:
The panel also had a number of administrative recommendations and suggestions:
Other suggestions included encouraging or mandating a preoperative sedation checklist, clarifying what should be included in the preoperative evaluation, and what constitutes an acceptable sedation/anesthesia record.
The panel also encouraged sharing of de-identified data on sedation/anesthesia with other state legislatures.
The panel’s review of incidents that had occurred in Texas included some of the following root causes and contributing factors:
The latter factor (long delays in calling 911 or otherwise activating the EMS) was the most common contributing factor identified, though it was not universal. The panel identified several root causes for such delays, including fear that such might lead to a regulatory investigation, considering the need for EMS as a personal failure, and lack of practice in crisis management.
One other factor suspected, but which was difficult to prove, was that in some cases the sedation provider may have left the dental operatory for a period of time, leaving the patient unobserved. Current rules in Texas require continuous presence of the sedation provider until the patient has reached a defined level of recovery.
The panel found that at least 2 major failures had occurred in all 6 major events and that no sedation related event would likely have occurred if all rules currently in place had been closely followed and failures avoided.
Note that the panel’s recommendations and suggestions are only additions or changes to existing rules and regulations in Texas. For example, there already is a rule that at least one member of the assistant staff be present during nitrous oxide/oxygen inhalation sedation. The dental provider may delegate monitoring of nitrous oxide/oxygen inhalation sedation (once pharmacologic and vital sign stability has been established) to an assistant who is certified by the SBDE to do so. Assisting staff must also be certified in BLS (Basic Life Support).
However, one important item we could not find in either their current regulations or the recommendations made by the panel is a statement about patient restraints or immobilization devices. You’ll recall that several of the events we described in our March 15, 2016 Patient Safety Tip of the Week “” involved use of a pediatric restraint called a “papoose” that may have contributed to the adverse outcomes. Our August 2016 What's New in the Patient Safety World column “” discussed the recently updated American Academy of Pediatrics (AAP)/American Academy of Pediatric Dentistry (AAPD) “Guideline for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures” (Coté 2016). That guideline has a good discussion about the use of immobilization devices, such as the “papoose” boards. Such must be applied in such a way as to avoid airway obstruction or chest restriction and the child’s head position and respiratory excursions should be checked frequently to ensure airway patency. If an immobilization device is used, a hand or foot should be kept exposed, and the child should never be left unattended.
It’s worth reiterating here some of the cases discussed in our March 15, 2016 Patient Safety Tip of the Week “”:
Deaths in patients who received sedation for dental procedures make the news every year (Otto 2014, AP 2015). Columns highlighting 8 (ABC News 2016) and 31 (Bradford 2012) respective deaths related to dental sedation provide some estimate of how frequently such complications of sedation occur. The most recent incident was just reported last week (George 2016). In this case a 4-year old girl suffered brain damage after receiving sedation for a dental procedure while being restrained by a device called a “papoose”. A CBS News report on this case (CBS News 2016) notes she was given multiple sedatives in the office for over seven hours for what was described as a routine dental procedure. Her heart rate was noted to be as high as 195 and her blood pressure to 168/77 and her oxygen saturation dropped as low as 49 percent. The “papoose” is a device confines the child's arms and legs so they can't interfere with the dental procedure. The CBS report notes that use of such devices for dental procedures in children is fairly widespread in the US and families and professionals need to be made aware of the dangers.
Another study, using primarily media reports, found 44 children who died subsequent to receiving anesthesia for a dental procedure in US dental offices, ambulatory surgery centers, and hospitals between 1980 and 2011 (Lee 2013). Most deaths occurred among 2–5 year-olds, in an office setting, and with a general/pediatric dentist as the anesthesia provider. In this latter group, 17 of 25 deaths were linked with a sedation anesthetic. That study likely significantly underestimates the number of serious complications from sedation and also did not include children who suffered neurologic injuries, suffered cardiac arrest, and were successfully resuscitated, or those who experienced respiratory arrest, but not cardiac arrest. The authors called for development of a national database for reporting both serious incidents related to dental sedation and near misses.
In a study of closed malpractice claims in pediatric dental patients 13 of 17 claims related to anesthesia involved sedation (Chicka 2012). The average patient age was 3.6 years and 6 involved the dentist as the anesthesia provider and the location was the dental office in 71% of cases. Only 1 claim related to sedation in which physiologic monitoring was used.
A prospective study of 51 patients needing dental treatment under oral conscious sedation found that postdischarge excessive somnolence, nausea, and emesis were frequent complications (Huang 2015). 60.1% of patients slept in the car on the way home and 21.4% of that group were difficult to awaken upon reaching home. At home, 76.1% of patients slept and 85.7% of patients who napped following the dental visit slept longer than usual.
Our August 2016 What's New in the Patient Safety World column “” also noted an article in Anesthesiology News (Kronemyer 2016) that referred to a KVUE TV “Defenders” investigation (Pierrotti 2016) which said at least 85 patients in Texas who died shortly following dental procedures from 2010 to 2015. We are not sure of the accuracy of that number since the current Texas blue ribbon panel only found 78 cases of mortality or patient harm related to dental sedation/anesthesia between 2012 and 2016. Only 19 of those 78 cases were deemed to be related to mishandling of sedation/anesthesia and only 6 were deemed to be serious events. The reason for the disparity between the KVUE TV investigation and the blue ribbon panel report is unclear. But I think we’d all agree that even one death or instance of patient harm from dental sedation/anesthesia is one too many. The KVUE TV investigation, however, clearly led to the intensive review and recommendations made by the blue ribbon panel.
In that August 2016 What's New in the Patient Safety World column “” we discussed the newly revised American Academy of Pediatrics (AAP)/American Academy of Pediatric Dentistry (AAPD) “Guideline for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures” (Coté 2016). The updated guideline, which applies to not just dental procedures but to sedation for all procedures, notes that children under the age of 6 years (and especially those under the age of 6 months) are particularly likely to suffer adverse events during sedation. It emphasizes that there is a very narrow margin in children between the intended level of sedation and much deeper sedation or anesthesia. Therefore, the practitioner must be trained not only in moderate sedation but must have the skills to rescue patients from such deeper levels. That would include the need for maintenance of the skills needed to rescue a child with apnea, laryngospasm, and/or airway obstruction, include the ability to open the airway, suction secretions, provide continuous positive airway pressure (CPAP), perform successful bag-valve-mask ventilation, insert an oral airway, a nasopharyngeal airway, or a laryngeal mask airway (LMA), and, rarely, perform tracheal intubation. The guidelines note these skills are likely best maintained with frequent simulation and team training for the management of rare events. The guideline has specific recommendations for when the intended level of sedation is minimal, moderate, deep or general sedation.
The updated guideline emphasizes the role of capnography in appropriate physiologic monitoring and continuous observation by personnel not directly involved with the procedure to facilitate accurate and rapid diagnosis of complications and initiation of appropriate rescue interventions. We are glad to see the Texas blue ribbon panel recommendation for use of capnography.
Patient safety considerations for procedural sedation begin in advance of the procedure. There should be a careful preprocedure review of the patient’s underlying medical conditions and consideration of how the sedation process might affect or be affected by such conditions. The guideline specifically mentions that children with developmental
disabilities have been shown to have a threefold increased incidence of desaturation compared with children without developmental disabilities.
The guideline also describes the “SOAPME” mnemonic to help teams remember all the equipment and supplies needed for conduct of safe sedation:
O Oxygen; an adequate reserve supply
A Airway; size-appropriate equipment to manage a nonbreathing child
P Pharmacy; drugs needed to support life and appropriate reversal agents
M Monitors; size-appropriate oximeter probes/monitors appropriate for procedure
E Equipment; a defibrillator with appropriately sized pads
Without going into details about specific drugs, the guideline notes the importance of selecting the lowest dose of drug with the highest therapeutic index for the procedure. That choice should also depend on whether the procedure is expected to be a painful or non-painful procedure. Knowledge about the duration of action of the drugs is important in informing how long a patient needs to be monitored after the procedure. That is especially important when combinations of drugs are being used (eg. a sedating agent and an analgesic or anxiolytic agent).
The guideline has specific recommendations for when the intended level of sedation is minimal, moderate, deep or general sedation. One critical point that should be of particular concern for dental practices, is that use of moderate or deeper sedation shall include the provision of a person, in addition to the practitioner, whose responsibility is to monitor appropriate physiologic parameters and to assist in any supportive or resuscitation measures. While that individual might also be responsible for assisting with interruptible patient-related tasks of short duration, such as holding an instrument or troubleshooting equipment, the primary role of that individual is monitoring the patient. For deep sedation the sole role of the support individual is to monitor the patient. In either case that individual should be trained in and capable of providing advanced airway skills (eg, PALS) and shall have specific assignments in the event of an emergency and current knowledge of the emergency cart/kit inventory.
Monitoring is critical and should include the level of patient’s ability to communicate (where assessable), heart rate, respiratory rate, blood pressure, oxygen saturation, and expired carbon dioxide values (via capnography) should be recorded, at minimum, every 10 minutes in a time-based record. The guideline stresses use of capnography but acknowledges that it may not be able to be used in some procedures around the face, including many dental procedures.
The guideline discusses the needs for the emergency cart/kit and backup emergency services access and availability.
The guideline has a good discussion about the use of immobilization devices, such as the “papoose” boards, as we discussed earlier in today’s column.
The guideline discusses what should be documented before, during, and after a procedure in which sedation is used and notes the importance of careful attention to calculating doses of drugs or infusions based on patient weight.
The guideline has a good discussion about discharge of the pediatric patient following a procedure in which sedation is used. It specifically highlights the dangers when a child is transported in a car seat where there is a need to carefully observe the child’s head position to avoid airway obstruction. Transportation in a car safety seat poses a particular risk for infants who have received medications known to have a long half-life. When there is only one adult to both drive and observe the child, there should be a longer period of observation in the facility where the procedure occurred. Discharge instructions should include details about what to look for, activity levels, dietary restrictions, and include a 24-hour phone number to call if necessary.
And while we have been emphasizing the application of the guideline to dental procedures, remember it applies to all diagnostic and therapeutic procedures. It has an excellent section on sedation in the MRI suite, which is a very restricted environment and has needs for special equipment and monitoring techniques as we have discussed in our numerous columns on patient safety issues in the radiology and MRI suites.
Proper patient selection, adherence to proper sedation technique, appropriate monitoring, and prompt intervention are obviously important when using sedation in any setting. But we are glad to see that the Texas blue ribbon panel has also emphasized the emergency planning aspect, including the need to perform drills which involve all members of a dental practice.
Sedation/anesthesia probably allows dental and oral surgery procedures needed by many young children. But it is not something that dental practices or parents of young children approach cavalierly. Guidelines like those outlined today need to be adhered to closely and a high level of vigilance incorporated into such dental practices.
Mehlhaf N. Vancouver boy, 4, dies after anesthesia used in dental procedure. KGW TV (Portland) March 14, 2017
Balick L and KOIN 6 News Staff. What parents should know about pediatric dentistry. The American Academy of Pediatric Dentistry is looking into what happened. WKBN News 2017; March 15, 2017
Coté CJ, Wilson S, American Academy of Pediatrics, American Academy of Pediatric Dentistry. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics 2016; 138(1): e2016121
State Board of Dental Examiners (Texas). Report to the Texas Sunset Advisory Commission by the Blue Ribbon Panel on Dental Anesthesia/Sedation Safety. January 4, 2017
Otto M. Dentist under investigation after sedated child dies. Association of Health Care Journalists. January 13, 2014
AP (Associated Press). Dentist charged in death of patient getting 20 teeth pulled. FoxNews.com Published February 18, 2015
ABC News. Children in Danger at the Dentist. ABC News. Accessed March 7, 2016
Bradford H. Dental Sedation Responsible For At Least 31 Child Deaths Over 15 Years. Huffington Post 2012; July 13, 2012
George C. Mom says dental restraint device led to child's brain damage. Preschooler remains hospitalized, conscious, but unable to talk, get up. Houston Chronicle 2016; March 10, 2016 Updated: March 11, 2016
CBS News. 4-year-old girl suffers brain damage after dentist visit, family says.
CBS News March 14, 2016
Lee HH, Milgrom P, Starks H, Burke W. Trends in death associated with pediatric dental sedation and general anesthesia. Pediatric Anesthesia 2013; 23(8): 741-746
Chicka MC, Dembo JB, Mathu-Muju KR, et al. Adverse events during pediatric dental anesthesia and sedation: a review of closed malpractice insurance claims. Pediatr Dent 2012; 34(3): 231-238
Huang A, Tanbonliong T. Oral Sedation Postdischarge Adverse Events in Pediatric Dental Patients. Anesth Prog 2015; 62(3): 91-99
Kronemyer B. Deaths of Children During Dental Procedures Raise Safety Concerns. Anesthesiology News 2016; June 30, 2016
Pierrotti A. Defenders: Investigating Dental Deaths. KVUE 2016; April 28, 2016