Anxiety and Pain Control in 2008:
An Update on Local Anesthesia and
Minimal Sedation via the Oral and
Inhalational Route
Iowa Dental Assoc.
May 4, 2008
J. Bruce Bavitz, DMD
ADA CELL Seminar Series
Today's ADA CELL Seminar Series is produced by
the AMERICAN DENTAL ASSOCIATION. This
valuable member service is partially underwritten
by generous grants from:
For further information about scheduling an ADA CELL Seminar Series
program, please call (312) 440-2908 or email seminarseries@ada.org.
ADA Membership
Call 1.800.232.1382 and
join 152,000 member dentists.
Learn about member benefits at
www. ADA.org.
Collect Data, Formulate Tx Plan
 History
 Follow-up
questions
 Exam
 Lab tests
Why bother with the medical
history and physical exam?






Will they get numb and sit still?*
Will they have a medical emergency?*
Will they stop bleeding?*
Will they resist infection?**
Will they heal?**
Will the operation ―work‖?**
*An intra-operative problem
**A post-operative problem
Common Changes/Modifications
from Normal Surgical Routine
Antibiotic Pre-medication
D/c anticoagulants
Prior Radiation Therapy ? Consider HBO
Oral, Nitrous oxide, or IV sedation
M.D. consult for tune up or ―clearance‖
Allergy (penicillin, latex, sulfite etc)
Abs + BCP…… Consider warning patient
Delay Elective TX (Pregnancy, MI, CVA)
Long acting or quickly metabolized local
anesthetics
 Limit epi to .04 mg for ―cardiac‖ patients
 Insulin dose modification for major oral surgery
 Bisphosphonate subplots









Rationale: Local Anesthesia
Adequately Controls Procedural
Pain for Most Patients,
However:
 Local anesthesia does not control all pain
on all patients (the perception of pain is
highly subjective).
 Local anesthesia does not treat fear or
anxiety. Although pain is subjective, we
do know it is proportional to anxiety.
Most patients who claim they are
“unable to get numb” have not
had their anxiety diagnosed and
treated….the local anesthesia is
working just fine.
Rationale ….continued
 Most patients dislike receiving local
anesthesia (The Needle)
 About 10 -30% of the U.S. Population avoid
dental care because of fear*
 Treating the ―stressed‖ patient is among the
least pleasant tasks for you and your staff
*Even 10% of the population in your
area = many untreated patients
Rationale ….continued
 Nervous patients are more likely to have
medical emergencies and nervous dentists
are more likely to make mistakes
 Some patients are unwilling or unable to
cooperate enough to receive local anesthesia
(extremes of age, mentally compromised,
cerebral palsy)
 Rarely, a patient may have a true local
anesthesia allergy
Rationale ….continued
 Some patients like, and are willing to
pay for, sedation.
 It is difficult to obtain profound local
anesthesia for some procedures (I+D,
endodontic access on acutely inflamed
pulps, reducing facial fractures,
extracting deeply impacted 3rds).
So, dentists should be able treat
pain/fear/anxiety with techniques
other than local anesthesia alone.
How To Diagnose Anxiety or Which
Patients Should I Offer To Sedate?
 From positive answers to fear/anxiety
questions on written medical history form
 From physical exam (elevated B.P., pulse,
―nervous‖ behavior)
 Information from your staff
 Past visits
 Patient tells you, or you ask
Pain/Anxiety Control Techniques
Pharmacologic
 Oral
 Inhalation
 I.M.
 I.V.
 Submucosal
 Others
Non-Drug
 Hypnosis
 Iatrosedation
 Electronic/TENS
 Acupuncture
Odontology. 2004 Sep;92(1):54-60. Effects of sounds
generated by a dental turbine and a stream on regional
cerebral blood flow and cardiovascular responses.
Mishima R, Kudo T, Tsunetsugu Y.
Effects of sound generated by a dental turbine and a small stream
(murmur) and the effects of no sound (null, control) on heart rate,
systolic and diastolic blood pressure, and hemodynamic changes
evaluated. Blood pressures changed in response to the murmur,
null, and turbine sound stimuli were as expected: lower than the
control level, unchanged, and higher than the control level,
respectively. Mean blood pressure values tended to increase
gradually over the recording time even during the null sound
stimulation, possibly because of the recording environment.
Surprisingly, heart rate measurements remained fairly stable in
response to the stimulatory noises. In conclusion, we demonstrate
here that sound generated by a dental turbine may affect cerebral
blood flow and metabolism as well as autonomic responses.
Anesthesia and Pain Control
Current Guidelines and Policy Statement
(Updated October 2007)
ADA Policy Statement: The Use of Sedation and
General Anesthesia by Dentists
Guidelines for the Use of Sedation and General
Anesthesia by Dentists |
PDF file/111k
Guidelines for Teaching Pain Control and
Sedation to Dentists and Dental Students |
PDF file/105k
“Sedation Depth is a Continuum”
Anxious
Minimal,.…Moderate,….Deep,.......GA
Iatrosedation
 Also known as good chair-side manner, is a non-drug
technique where the doctor and his/her staff lessen
a patient’s fear/anxiety. If a patient perceives
empathy, competence, and caring in the dental
team, then anxiety is lessened leading to a more
positive experience. There are no contraindications
to iatrosedation, and it therefore should be applied
to all patients.
Anxiolysis (Minimal Sedation)
 The diminution or elimination of anxiety
 Respond normally to verbal commands
Conscious (Moderate) Sedation
 A medically controlled state of
depressed consciousness that :
1. Allows protective reflexes to be maintained
2. Retains the patient’s ability to maintain a
patent airway independently and continuously
3. Permits appropriate response by the patient
to physical stimuli or verbal command
Deep Sedation
 A medically controlled state of depressed
consciousness or unconsciousness from
which the patient is not easily aroused.
 It may be accompanied by a partial or
complete loss of protective reflexes,
including the inability to maintain a patent
airway and/or respond to verbal command.
General Anesthesia
 A medically controlled state of
unconsciousness accompanied by a loss
of protective reflexes, including the
inability to maintain and airway and
respond purposefully to physical
stimulation or verbal command.
 The elimination of all sensation, with
total amnesia for the surgical procedure.
General Anesthesia
 The trip from awake and alert to general
anesthesia has been divided into 4 stages
by Guedel.
– Stage 1 corresponds to conscious sedation,
with stage 3 equating to general anesthesia.
– Stage 2 is heralded by excitement and
delirium (insert video of relative at wedding
reception), with stage 4 being near
cardiovascular collapse.
You have consciously (moderate, stage 1)
sedated a patient with IM Demerol and Versed
for extraction of six teeth. What is true about
the local anesthesia with epinephrine?
A. Optional; may use if hemostasis is desired
B. Contraindicated; epinephrine and narcotics can
produce arrhythmias
C. Necessary for adequate pain control
D. Unnecessary; pain control achieved through
your narcotic premed
Sedation Golden Rules
 Most patients do well with iatrosedation,
and one drug, the local anesthetic.
 When administering sedative drugs, one
should still use good chair side
techniques.
 If you are sedating a patient, then you
need to know their medical history even
better than if using L.A. alone.
Sedation Golden Rules
 All sedatives/anxiolytics, regardless of the
route of drug administration, can place
the patient into deep sedation or general
anesthesia.
 Most morbidity/mortality from dental office
sedations are from respiratory arrest.
 You should be able to manage (rescue)
patient one level beyond your intended depth
(~manage pulp exposure if doing operative)
Sedation Golden Rules
 Patients under 6 or over 65 require special
precautions.
 A consciously sedated patient is less likely to
have a medical emergency than a person
with local anesthesia alone, but general
anesthesia is risky on the medically
compromised person.
 Each state has its own rules and regulations
regarding sedation in the dental office.
 Analgesia: The diminution of pain in the
conscious patient.
 Local Anesthesia: The elimination of
sensations, especially pain, in one part
of the body by the topical application or
regional injection of a drug.
Iatrosedation
Deep Sedation
Anxious
Dead
Cs Sedation
G.A.
Fasting not necessary…light meal
Fasting recommended…clear liquids OK
Fasting mandatory
SBP < 120 and
DBP < 80
B.P.
All new patients and prior to
giving local anesthesia
No modification necessary
SBP > 120 or
DBP > 80
Iatrosedation
Consider nitrous oxide or oral sedation
Repeat BP in 5-10 minutes
SBP
DBP
120-159
and
80-99
SBP > 160
or
DBP > 100
SBP < 120 and
DBP < 80
No modification necessary but
consider sedation for future
appointments
Hypertensive symptoms?
Headache, chest pain
Shortness of breath
Visual changes, confusion
Urgent physician or
emergency room
referral
Proceed with procedure but limit
epinephrine to .04 to .06 mg/
15 minutes. Inform patient of
elevated BP and refer to
physician
No Hypertensive Symptoms
(Post dental care physician referral
for all below scenarios)
Elective
Dental Care
ASA I
> 10 MET
Proceed as planned.
Limit time and
epinephrine
ASA II-IV
< 10 MET
No invasive care.
Prescribe meds as
necessary
Emergency
Dental Care
ASA I
> 4 MET
Proceed with
emergency care
Limit time and
epinephrine
ASA II-IV
< 4 MET
Physician phone consult.
Minimal emergency
care only (I & D,
simple extractions)
The concept of metabolic equivalent or METS is in
vogue. One MET is defined as 3.5 ml of 02/Kg/min. It
essentially is a test of the patient’s ability to perform
physical work. Some examples are:
1-4 METS (eating, dressing, walking around house,
dishwashing)
4-10 METS (climbing stairs – 1 flight, walking level ground
6.4 km/hr, running short distance, game of golf)
> 10 METS (swimming, singles tennis, football)
People with capacities of 4 METS or less are at high risk for
medical complications, while those who can perform 10 METS or
more at very low risk. A person who is anxious with a BP
200/115 but can perform 10 METS of work would likely have no
problems with a simple extraction.
Sedation Lowers BP
 Grossman looked at treating hypertensive patients
with 5 mg of diazepam versus the ACE inhibitor,
captopril. Patients in this study presented to the
emergency room with blood pressure readings
greater than 190/100 and responded equally well to
both treatments, reducing, on average their systolic
blood pressure by an impressive 30 mm Hg, and
diastolic values by 25 mm.
 Grossman E, Nadler M, Sharabi Y, Thaler M, Shachar A, Shamiss A.
Antianxiety treatment in patients with excessive hypertension. Am J
Hypertens 2005; 18(9 Pt 1):1174-7.
Prevent serious medical
emergencies in your practice by:
Placing the office in the 3rd or 4th floor of a
building without an elevator
Sedation...Why not?
 Possible serious complications
 Hassles with permits
 Mandated CE Hours
 Increased malpractice $
 Doing OK without it
 Never taught how
 Need to buy more equipment
Once the sedation decision is
made, you select:
 Which drug(s).
 Which route of drug administration.
Don’t Forget: Signed
Written Informed Consent for
Anesthesia and the Procedure
 Must NOT be under influence of sedative
agent while signing, or validity might be
questioned
 Need parent/guardian’s signature for
minor
Practical Oral Sedation in Dentistry
Part I: Pre-Sedation Consideration and Preparation
Compendium, Vol 27:6, 2006
Dominic P Lu, DDS; Winston I Lu, PharmD
Drug Titration
 The ―Bell‖ Curve -- everybody is different
 Routes of drug administration that allow
you to quickly achieve peak blood levels
give you the ability to predictably
achieve the desired level of sedation.
Only the I.V. and inhalational route allow
for this, which is why deep sedation and
G.A. are safely achieved via these routes.
Bell Curve: Response after 10 mg Diazepam
0 = No Response, 10 = Ideal,
20 = General Anesthesia
Routes of Drug Administration
 Oral
 Inhalation
 I.V.
 I.M.
 Transmucosal/Transdermal
 Other
 Each has unique positives and negatives
Most states regulate dentist’s ability
to perform sedation by route of drug
administration, but depth of sedation
is really the bottom line.
Any route of drug administration may
render the patient into planes where
respiration is depressed, and most
self-administered drug overdoses
(suicides) are given via the oral route.
Someday, all states will assess didactic
and psychomotor competency via
standardized exams on patient simulators,
analogous to passing a BLS exam
Oral
+
Acceptance
No special skills
Low side effects
No extra equipment
Pt. Can take night
before
 No extra state
permit?





Variable absorption
First pass effect
Need compliance
~ 1 hour to peak,
therefore can’t easily
titrate
 May actually reach
maximum sedation
after discharge!




Inhalational
+
 Rapid onset/peak
effect
 Can titrate
 Quick elimination
(Pt. can often drive
self home)
 No extra state
permit?




Special equipment
Special skills
Need compliance
Waste gas
Hypothesis: The risk of sedating
an anxious patient with nitrous
oxide/oxygen alone is less than
not sedating that same person
 States should consider dropping any
requirements for nitrous oxide permits and
instead issue them to dentists who fail to
recognize and treat (or refer) anxious
patients
I.M.
+
 Least cooperation of
all techniques
 No special skills
 Useful in
emergencies
 Bypasses gut
 Titration Difficult
 Hurts
 Parenteral route,
need advanced
monitoring and
possible ―extra‖
state permit
I.V.
+
-
 Fastest onset
 Can titrate
 Most predictable (safest
to go deep)
 Best route for
emergency drugs
 Predictable Amnesia
 Special skills
 Need cooperation
 Special
equipment/Permit
 Adverse drug reactions
most rapid and intense
 Malpractice $
A Priori logic would suggest that the
IV route should be the safest.
Sedation of the
Future?
“PatientControlled
IV Sedation”
Milk of amnesia
How Deep is the Patient?
Monitor
 CNS
 Respiration/Ventilation
 Cardiovascular
 Temperature
CNS
 Sedative drugs effect the CNS first,
sensory nerves before motor
 For conscious sedation, the patient
should be able to talk and respond
appropriately to command
University of Michigan
Sedation Scale (UMSS)
0 Awake and alert
1 Minimally sedated: tired/sleepy, appropriate
response to verbal conversation and/or
sound
2 Moderately sedated: somnolent/sleeping,
easily aroused with light tactile stimulation
or a simple verbal command
3 Deeply sedated: deep sleep, arousable only
with significant physical stimulation
4 Unarousable
Responsiveness Scores of the
Modified Observer’s Assessment of
Alertness/Sedation Scale (OAA/S)
5 Responds readily to name spoken in normal
tone (alert)
4 Responds lethargically to name spoken in
normal tone
3 Responds only after name is called loudly
and/or repeatedly
2 Responds only after mild prodding or shaking
1 Responds only after painful trapezius squeeze
0 Does not respond to painful trapezius squeeze
The American Academy of Pediatric Dentistry and
American Academy of Pediatrics have stressed the
importance of monitoring vital signs and level of
consciousness during sedation to ensure patient safety.
At present, there is no objective, universally accepted
measure for level of sedation.
Bispectral analysis (BIS) monitoring is a relatively new,
noninvasive technology used clinically to evaluate level
of sedation. This technology is based on the principle
that electroencephalogram wave forms change with the
level of alertness. In general, when an individual is
awake, electroencephalogram waveforms are high
frequency and low amplitude. When the individual is
deeply sedated, the frequency decreases and amplitude
increases, and there are changes in relationships
among different frequencies
Using these principles, an algorithm for digital
signal processing was developed that produces a
numeric value known as the BIS index, ranging
from 0 to 100. The manufacturer’s guidelines
are as follows: a BIS index of 70 to 90
represents light to moderate sedation, 60 to 70
deep sedation, 40 to 60
general anesthesia, and
less than 40 a deep
hypnotic state. A BIS score
of 0 represents no brain
activity and is seen in
coma and death
Anesth Analg. 2006 Aug;103(2):385-9. Bispectral
index does not correlate with observer assessment
of alertness and sedation scores during 0.5%
bupivacaine epidural anesthesia with nitrous oxide
sedation. Park KS, Hur EJ, Han KW, Kil HY, Han TH.
Anesthesiologists should be aware that the BIS
monitor may not be sensitive enough to provide an
adequate measure of the depth of sedation and
hypnosis when using N2O alone for sedation. It may
be better to monitor sedation clinically (e.g., with the
OAA/S scale) to determine the dose requirement
and the adequacy of depth of sedation and hypnosis.
Respiration
 Morbidity/Mortality from outpatient sedations most
often are due to respiratory arrest.
 Sedative drugs depress respiratory rate and tidal
volume before the cardiovascular system.
 Pulse oximetry is the standard of care for assessing
respiration and thus oxygenation.
 Also assess color of blood, breath sounds and
respiratory rate
 Capnography (CO2 monitoring) useful for GA
Pulse Oximetry
 Non-invasively, measures percent
oxygenation of hemoglobin in capillary
blood
 Also measures heart rate
 Should maintain above 90%
Cardiovascular
 Blood Pressure
 EKG
 Heart Rate
Type and Frequency of Monitoring
Depends on Depth of Sedation
 Local Anesthesia: Pre-op B.P. and pulse
 Nitrous Oxide and Conscious Sedation via oral route:
Continuous talking to patient, and Pre, Intra and
Post-op B.P. and Resp. rate. If patient driving self
home (Nitrous Only), then Pre/Post-op Trieger Test
 Parenteral Conscious/Deep Sedation: Continuous
pulse oximetry, q5 min. B.P.
 G.A.: Continuous pulse oximetry, Capnography, EKG,
Temperature, q5 min B.P., BIS monitor?
Patient Name
NITROUS OXIDE/SEDATION RECORD
Student Nam e
Date
Faculty Name
Assistant
MED History (circle): Pregnancy
URI
Recent Retinal Surgery
Psych
Drug Allergies (List)
_______________
PreOP Vitals: BP
Pulse
Oral Sedation Time
Drug
Resp
Consent Prior to Sedation?
_______________________
Dose
PreOP Trieger Test
IntraOP volumes: Nitrous
IntraOP vitals: BP
LPM
Pulse
O2
LPM
Resp
Nitrous Initiated (Time)
PostOP 100% O2:
minutes
PostOP vitals: BP
Pulse
Resp
PostOP Trieger Test
PT Discharge Condition
Discharged to (circle):
Other
Self
PT Discharge Time
Spouse
Parent
Other
Yes
No
B.P./O2 Sat. + Printer
E.K.G.
Emergency Equipment
(Crash Cart)
 B.L.S. most important, with the
ability to breath for someone who
isn’t… mouth-to-mouth, mouth-tomask, bag/valve /mask, intubation
 Reversal Drugs
 Supplemental O2
 AED
Automatic External
Defibrillator
The Ideal Anxiolytic







Not antigenic
Cheap
Effective via any route
Rapidly absorbed if given P.O.
Tastes good (like chicken)
Reversible --- has an antidote
Makes patient happy, motionless, possibly
amnesic
The Ideal Anxiolytic
 Favorable Therapeutic Index (safe)…
The perfect anxiolytic acts only on the
emotion center of the CNS, not influencing
the respiratory or cardiovascular systems
 Quickly and completely metabolized
(no active by-products) without help form
the patient’s kidneys, liver, etc.
 Non-addicting
Oral Agents
 ETOH
 Barbiturates
 Benzodiazepines
 Antihistamines
 Narcotics
 Others
Benzodiazepines
 Less respiratory depression and hangover
effects compared to barbiturates., work on
limbic system in ―GABAnergic‖ way, favorable
T.I., schedule 4 agents, older agents cheap,
antidote (Romazicon)
 Teratogenic, paradoxical excitement in some
kids, psychologically addicting, newer agents $
Differences between drugs in this class are
mostly due to their duration of action…..short
being good for dentistry.
Benzodiazepines: The Big 3
 Diazepam (Valium) long half-life (~24
hr.) with active metabolite, cheap
 Triazolam (Halcion) popular sleeping pill,
short half-life (~3 hours)
 Midazolam elixir (Versed) ―Approved‖ for
use in children. New and relatively
expensive, rapid absorption via oral
route, PDR urges caution RE respiratory
depression.
Other Benzodiazepines
 Lorazepam (Ativan)
 Alprazolam (Xanax)
 Oxazepam (Serax)
 Temazepam (Restoril)
 Flurazepam (Dalmane)
Triazolam
U.S. Brand Names: Halcion
Generic Available: Yes
Children <18 years: Dosage not established.
Adults maximum dose: 0.5 mg/day
Sedation for dental procedure: 0.25 mg taken the
evening before oral surgery; and/or 0.25 mg 1 hour
before procedure
(Sublingual administration results in a 28 percent greater
bioavailability compared with oral administration, in turn
resulting in higher plasma concentrations at one to two
hours after the drug is administered Sublingual
administration of triazolam should produce a faster onset
and enhance titration ability by reducing some of the
variables associated with oral administration)
Metabolic Subplots
 CYP3A enzymes in the intestines and the liver
metabolize triazolam. Antiretroviral agents
inhibit CYP3A, resulting in a two-fold increase
in plasma concentrations.
 Other CYP3A4 inhibitors include azole
antifungals, ciprofloxacin, clarithromycin,
diclofenac, doxycycline, erythromycin,
imatinib, isoniazid, nefazodone, nicardipine,
propofol, protease inhibitors, quinidine, and
verapamil.
Midazolam
U.S. Brand Names: Versed
Dosage needs to be individualized based on the patient’s age,
underlying diseases, and concurrent medications. Decrease dose
(by ~30%) if narcotics or other CNS depressants are
administered concomitantly. Children <6 years may require
higher doses and closer monitoring than older children; calculate
dose on ideal body weight. Personnel and equipment needed for
standard respiratory resuscitation should be immediately
available during administration.
Children: Conscious sedation for procedures or preoperative
sedation:
Oral: 0.25-0.5 mg/kg as a single dose preprocedure, up to a
maximum of 20 mg; administer 30-45 minutes prior to
procedure. Children <6 years and uncooperative patients may
require as much as 1 mg/kg as a single dose; 0.25 mg/kg may
suffice for children 6-16 years of age.
Reversal Agent (Antidote)
ROMAZICON is indicated for the complete or partial reversal of the
sedative effects of benzodiazepines in cases where general
anesthesia has been induced and/or maintained with
benzodiazepines, where sedation has been produced with
benzodiazepines for diagnostic and therapeutic procedures, and
for the management of benzodiazepine overdose.
ROMAZICON® (flumazenil)
INJECTION
The use of Romazicon has been associated with the occurrence of
seizures. These are most frequent in patients who have been on
benzodiazepines for long-term sedation or in overdose cases
where patients are showing signs of serious cyclic antidepressant
overdose. Practitioners should individualize the dosage of
Romazicon and be prepared to manage seizures.
For the reversal of the sedative effects of benzodiazepines
administered for conscious sedation, the recommended
initial dose of ROMAZICON is 0.2 mg (2 mL) administered
intravenously over 15 seconds. If the desired level of
consciousness is not obtained after waiting an additional 45
seconds, a second dose of 0.2 mg (2 mL) can be injected and
repeated at 60-second intervals where necessary (up to a
maximum of 4 additional times) to a maximum total dose of
1 mg (10 mL).
The intramuscular, subcutaneous and sublingual routes of
flumazenil injection have been studied in dogs. Although
reversal of midazolam-induced respiratory depression was
successful with all injection methods, the mean reversal time
was significantly shorter with intravenous administration
(120 versus 262 seconds with sublingual administration).
Gen Dent. 2005 Jan-Feb;53(1):22-6. Rehabilitation
of a fearful dental patient with oral sedation: utilizing
the incremental oral administration technique.
Feck AS, Goodchild JH.
The treatment of fearful or anxious patients presents a
myriad of problems for the dentist. In-office sedation
using oral (enteral) medications is an effective means of
increasing patient tolerance of invasive dental
procedures. The incremental oral administration
technique is a protocol that can be utilized to treat
fearful or anxious patients. A case is presented in which
this technique was used as an adjunct to the
rehabilitation of a debilitated mouth.
ADA/AAOMS Position: 2003
 Titration of oral medications for the purpose
of sedation is unpredictable
 Can produce alteration in the state of
consciousness beyond the intent of the
provider.
 Combination inhalational – enteral sedation
raise the risk of oversedation
 Should not exceed manufacturer’s
recommended dosage
Balancing efficacy and safety in the use of
oral sedation in dental outpatients. J Am
Dent Assoc, Vol 137, No 4, 502-513. April
2006.
Raymond A. Dionne, DDS, PhD; John A. Yagiela,
DDS, PhD; Charles J. Coté, MD; Mark Donaldson,
PharmD; Michael Edwards, DMD; David J.
Greenblatt, MD; Daniel Haas, DDS, PhD; Shobha
Malviya, MD; Peter Milgrom, DDS; Paul A. Moore,
DMD, PhD, MPH; Guy Shampaine, DDS; Michael
Silverman, DMD; Roger L. Williams, MD; and
Stephen Wilson, DMD, MA, PhD.
Overview. There is a strong need and demand for adult
and pediatric sedation services. Using oral medication to
achieve anxiolysis in adults appears to have a wide
margin of safety. Mortality and serious morbidity,
however, have been reported with oral conscious
sedation, especially in young children. Most serious
adverse events are related to potentially avoidable
respiratory complications.
Conclusions. Clinical trials are needed to evaluate oral
sedative drugs and combinations, as well as to develop
discharge criteria with objective quantifiable measures of
home readiness. Courses devoted to airway management
should be developed for dentists who provide conscious
sedation services. State regulation of enteral
administration of sedatives to achieve conscious
sedation is needed to ensure safety.
Aldrete Score: Maximum 10
Activity:
Able to move four extremities voluntarily on command 2
Able to move two extremities voluntarily on command 1
Able to move no extremities voluntarily on command
0
Respiration:
Able to breath deeply and cough freely
Dyspnea or limited breathing
Apnea
2
1
0
Circulation:
BP +/- 20 of preanesthetic level
BP +/- 21-49 of preanesthetic level
BP +/- 50 of preanesthetic level
2
1
0
Consciousness: Fully awake
Arousable on calling
Not responding
2
1
0
O2 Saturation:
2
1
0
Able to maintain O2 saturation > 92% on room air
Needs O2 inhalation to maintain O2 saturation > 90%
O2 saturation < 90% even with O2 supplement
What’s new in Nitrous Oxide?
 Absolute contraindication?
 More data on chronic effects
 More emphasis on waste gas hygiene
Int J Neurosci. 2006 Jul;116(7):847-57.
Psychotropic analgesic nitrous oxide
for acute cocaine withdrawal in man.
Gillman MA, Lichtigfeld FJ, Harker N.
This article reports the first single-blind
study using psychotropic analgesic nitrous
oxide (PAN) for treating acute withdrawal
states following cocaine abuse.
Nitrous Oxide
Nitrous oxide Online.
Shop Target.com.
Waste Gas…
What’s the Problem?
 Early data suggested possible link
between chronic, low level exposure
and fertility problems
 Best study to date: NEJM Rowland,
Oct. 1992
 Specifically looked at relationship
between amount of N2O exposure
and the ability of dental assistants to
become pregnant
NEJM: Results
 459 pregnant D.A. participated in study
 Those exposed to more than 5 hours per
week of non-scavenged N2O had greater
problems conceiving that was statistically
significant
 Higher rate of spontaneous abortion
 D.A.s in offices that used N2O > than 5 hours
per week but scavenged - no different success
than offices that didn’t use N2O at all
Reducing Waste Gas




Can measure N2O in operatory (infrared detectors, N2O badges)
Levels around DDS/D.A. can reach 1000 ppm
With upgrades, can reduce this to < 50 ppm
No State*/Federal laws yet, but NIOSH recommends < 50 ppm
*Nitrous Oxide CDA 2007
Safe Use of Nitrous Oxide
For nitrous oxide, an employer needs to monitor the work environment if
the employer or any staff member believes individual staff may be
exposed to concentrations in excess of 50 ppm, which is a timeweighted average permissible exposure limit (PEL) for an eight-hour
day. Effective scavenging equipment and periodic inspection of
equipment should keep nitrous oxide exposures to within acceptable
limits.
Reducing Waste Gas: How
 Scavenging Masks (patient must exhale
through nose)
 Increased room ventilation (fans, open
windows, open operatories)
 Auxiliary suction devices
 Frequent checks for leaks
National Institute for Occupational Safety and Health
http://www.cdc.gov/niosh/nitoxide.html
http://www.cdc.gov/niosh/noxidalr.html
Scavenging Masks
Scavenging Masks
 Exhaled air is sucked away, out HVE line
(Where does your waste gas go?)
 Suction set @ 45 lpm: too much, patient
doesn’t get N2O , too little gas into room
 Mask must fit tight, otherwise gas escapes
 Patient exhales through mouth? — gas
escapes
 Patient talks? — gas escapes
BMJ 2002;325:532-533 (7 September)
Nitrous oxide anaesthesia in the presence of
intraocular gas can cause irreversible blindness.
Y F Yang, a, L Herbert, a, H Rüschen, a.
Retinal detachment arising from a retinal break occurs in about
1 person per 10 000 per year. Spontaneous retinal reattachment
is rare, and retinal reattachment surgery is required to prevent
irreversible total loss of vision. Modern vitreoretinal techniques
often use intraocular gases as tamponading agents. These gases
may persist in the eye for up to three months after surgery.
During this period further anaesthesia using nitrous oxide will
cause the intraocular gas bubble to expand, which can result in
sight threatening increases in intraocular pressure. We present a
case in which this occurred with devastating consequences.
What’s New and Groovy in Local




New Drugs
Compounded Topicals
Novel Delivery Methods
Reversal Agent
Phentolamine
History
 W. Halsted injected cocaine for dental
procedures 1884
 Procaine (Novocain) synthesized 1905
 Lidocaine, the first amide, released 1948
 Long acting Bupivacaine became available in
USA in 1983
 Articaine available in Germany, 1976 and in
the USA, 2000
New Drugs
 Articaine
 Ropivacaine
Levobupivacaine
Articaine
Why do some patients not require
any local anesthesia?
J Hypertens. 1999 Dec;17(12 Pt 2):1799-804.
Relationship between dental pain perception
and 24 hour ambulatory blood pressure: a study
on 181 subjects.
Guasti L, Zanotta D, Petrozzino MR.
OBJECTIVE: To investigate dental pain
perception in a large group of essential
hypertensive subjects.
METHODS: A total of 130 hypertensive patients
together with 51 normotensive subjects were
submitted to tooth-electrical stimulation to
determine the dental pain threshold (occurrence
of pulp sensation) .
CONCLUSIONS: The correlation between both
baseline and 24 h blood pressure and pain
perception has been confirmed in a large group
study of normotensive and hypertensive subjects.
Moreover, even among the hypertensive range of
blood pressure, the higher the blood pressure is,
the lower the sensitivity to pain is.
Articaine
 In use in other countries since 1976
 Marketed in US as a 4% solution under brand
names Septocaine or Zorcaine with
epinephrine @ 1:100,000, or 1:200,000
 Has thiophene (Sulfur containing) ring
 Similar to Lidocaine in duration
Articaine
What’s Hot
 Better diffusion through
bone-possible elimination
of need for palatal
injections (and
mandibular blocks?)
 Faster onset
 Shorter systemic half-life
(20 min. vs. 90 min. for
Lidocaine)





What’s Not
~1.5 X the cost
Avoid in Sulfa allergic
patients?
Improved efficacy not
universally believed
For 70kg patient, can
―only‖ give ~7 cartridges
(7mg/kg, 68mg/cartridge)
―Non-Surgical‖
Parasthesias?
Articaine…..Bottom Line
 Don’t Use for Mandibular or Lingual Nerve
Blocks
 Caution if anesthetizing ―entire mouth‖ all at
once
 Better Diffusion through Bone
 Do use if anesthetizing ―entire mouth‖ over 2 3 hours (dental school full mouth extractions)
Ropivacaine
Levo Bupivacaine
 Not ―approved‖ yet for dentistry in USA
 Long acting like Bupivacaine
 Less neuro and cardio toxic
 Ropivacaine a mild vasoconstrictor
 Levo Bupivacaine, is actually the ―S‖
enantiomer of ―regular‖ Marcaine
Local Anesthesia..…Some patients
don’t like that persistent
swollen/numb feeling*
Why not ―reverse‖ the local?
*Often beneficial following surgery
October 2006 NOVALAR Announces Positive Phase 3
Results For Novel Dental Anesthesia Reversal Agent
Novalar Pharmaceuticals, Inc. today announced that NV-101, a local
dental anesthetic reversal agent, was well tolerated and met its primary
endpoints in two pivotal Phase 3 studies. In both trials, NV-101 treated
patients reported the return of sensation in less than half the amount of
time it normally took after receiving local dental anesthesia.
Novalar Raises $30 Million in Series D Financing
Nov. 1 2007 - Novalar Pharmaceuticals, Inc., a specialty pharmaceutical
company focused on developing and in-licensing novel oral healthcare solutions,
announced today that it has closed a $30 million Series D financing. The
proceeds will be used to support the U.S. launch of NV-101, a first-in-class, local
dental anesthetic reversal agent, and the development of other innovative dental
pharmaceuticals in Novalar's pipeline.
If approved by the FDA, NV-101 will be the only local anesthetic reversal agent that
accelerates the return to normal sensation and function following restorative and
periodontal maintenance procedures. The product has been tested in pediatric,
adolescent and adult patients. Phentolamine mesylate (a vasodilator), the active
ingredient in the investigational agent NV-101, has been approved and in use in
specific medical indications significantly higher doses for over 50 years.
It’s the first FDA approved needlefree subgingival anesthetic agent
providing patients an option in
anesthesia for SRP procedures.
International Academy of
Compounding Pharmacists
 Pharmacy Compounding is...
– the long-established tradition in pharmacy
practice that enables physicians to prescribe
and patients to take medicines that are
specially prepared by pharmacists to meet
patients’ individual needs.
FOR IMMEDIATE RELEASE
December 5, 2006
FDA Warns Five Firms To Stop Compounding Topical
Anesthetic Creams
The Food and Drug Administration (FDA) is warning five firms,
Triangle Compounding Pharmacy, University Pharmacy, Custom
Scripts Pharmacy, Hal’s Compounding Pharmacy, and New
England Compounding Center, to stop compounding and
distributing standardized versions of topical anesthetic creams,
which are marketed for general distribution rather than responding
to the unique medical needs of individual patients.
FDA is concerned about the serious public health risks related to
compounded topical anesthetic creams. Exposure to high
concentrations of local anesthetics, like those in compounded
topical anesthetic creams, can cause grave reactions including
seizures and irregular heartbeats. Two deaths have been
connected to compounded topical anesthetic creams
J Am Dent Assoc. 2007 Oct;138(10):1333-9.
The use of compound topical anesthetics: A review.
Kravitz ND.
Clinical Implications. Compound topical anesthetics
may be an effective alternative to local infiltration for
some minimally invasive dental procedures; however,
legitimate concerns exist in regard to their safety. Until
they become federally regulated, compound topical
anesthetics remain unapproved drug products whose
benefits may not outweigh their risks for dental patients.
Topicals…Bottom Line
 Use compounded agents with great care
 Use esters with great care
 Recall some trans-mucosal systemic
absorption with all drugs
Alternate Delivery Methods
 Computer delivered
 Intra osseous
Advantages of Intraosseous LA
 Improved LA efficacy (Getting the hot tooth numb)
 Reduce LA volume
 Anesthetizing only the tooth…..no more numb
lips/tongue
 No palatal injections
Disadvantages of Intraosseous
 Rapid absorption, possible tachycardia
depending on epi concentration
 Drilling into roots
 Drilling into IAN
 Increased cost
 No Transitional Dentition
 Can’t use through thick bone (2nd Molars)
Computer controlled injections
 What’s Hot
 What’s Not
 Less pain during
injections….less intra
and post- op too?
 Improved tactile sense
 Fun to use
 Cost
 Results may be no
better if operator injects
slowly
 Hassle to use
Up your nose with a local anesthetic?
―The procedure was explained to the
patient including its risks benefits
and alternatives and all questions
were answered.‖
Consent for local anesthesia too?
Other LA Controversies…. Data is
equivocal
 Large needles (25 gauge) hurt more than
small needles
 ―Warming‖ the local anesthetics reduce pain
during the injection
 Defense wins Super-Bowls
Conclusions
 Don’t forget to diagnose anxiety; consider it a
disease that can be treated
 For general dentistry, most patients do well
with local anesthesia and iatrosedation
 Nitrous and/or oral sedation improves
outcomes on the nervous patient
 Avoid using Articaine for mandibular blocks?
Employ appropriate modifications,
so all below answers are yes







Will they get numb and sit still?
Will we prevent a medical emergency?
Will they stop bleeding?
Will they resist infection?
Will they heal?
Will the operation ―work‖?
Will they have a positive experience,
and want to come back?
Questions?
jbavitz@unmc.edu