Patient Safety Tip of the Week
March 28, 2017
More Issues with Dental Sedation/Anesthesia
Our March 15, 2016
Patient Safety Tip of the Week “Dental
Patient Safety” 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 “Guideline
Update for Pediatric Sedation”.
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:
- Dentists should have in
place written emergency protocols and be required to document that these
protocols are practiced with office staff using drills or similar
exercises.
- At least one support staff
member assisting with a sedation procedure must receive training in
recognition and management of sedation/anesthesia related emergencies.
- Age-specific sedation
training (for moderate/deep/general anesthesia) must be documented for
those dentists providing services to children under the age of 8 and also
for other “high risk” patients (eg. BMI ≥ 30,
ASA class 3 or 4, age 75 or older).
- Basic ventilation
equipment must be onsite at all sites, including offices where portable
providers practice.
- Capnography and a
precordial stethoscope are mandated for procedures using moderate/deep/general
anesthesia.
The panel also had a number of administrative
recommendations and suggestions:
- The State Board of Dental
Examiners (SBDE) should have full authority to inspect dental offices with
emphasis on assessing the competency of the sedation provider.
- SDBE should have a
standing independent sedation advisory panel to review and advise regarding
sedation/anesthesia issues.
- SDBE should collect data
regarding sedations performed and make public de-identified sedation
related major events and mishaps.
- The sedation record
should be a required part of the dental record even if the sedation
provider is a non-dentist.
- SDBE should create a
system for review and approval of continuing education for
sedation/anesthesia.
- SDBE should also consider
creation of a written examination for sedation/anesthesia (and consider
putting it online).
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:
- Emergency drugs were
available but given in the wrong dose
- Emergency ventilation
equipment was available but used ineffectively
- Emergency ventilation
equipment was not available
- Supplemental oxygen was
available but not administered when indicated
- The provider was slow to activate
the emergency medical system (EMS)
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 “Dental
Patient Safety” 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
“Guideline
Update for Pediatric Sedation”
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 “Dental
Patient Safety”:
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 “Guideline
Update for Pediatric Sedation”
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 “Guideline
Update for Pediatric Sedation”
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:
S Suction
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.
References:
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
http://wkbn.com/2017/03/15/what-parents-should-know-about-pediatric-dentistry/
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
http://pediatrics.aappublications.org/content/138/1/e20161212
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
https://lintvkxan.files.wordpress.com/2017/01/anesthesia-recommendations-final-report.pdf
Otto M. Dentist under investigation after sedated child
dies. Association of Health Care Journalists. January 13, 2014
http://healthjournalism.org/blog/2014/01/dentist-under-investigation-after-sedated-child-dies/
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
http://abcnews.go.com/Blotter/photos/children-danger-dentist-16763974/image-16764081
Bradford H. Dental Sedation Responsible For At Least 31
Child Deaths Over 15 Years. Huffington Post 2012; July 13, 2012
http://www.huffingtonpost.com/2012/07/13/dental-sedation-child-deaths_n_1671604.html
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
http://www.cbsnews.com/news/4-year-old-girl-suffers-brain-damage-after-dentist-visit/
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
http://www.kvue.com/news/investigations/defenders/defenders-investigating-dental-deaths/158354392
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