Professional Documents
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Office
a b, a
Francesco R. Sebastiani, DMD , Harry Dym, DDS *, Joshua Wolf, DDS
KEYWORDS
Anxiolysis Conscious sedation Clinical technique Safety Regulation
KEY POINTS
There is a strong need and demand for adult and pediatric enteral sedation services in
dentistry.
Knowledge of the potential risks and benefits of oral sedatives is absolutely necessary to
allow the clinician to use an effective anesthesia technique safely in the office setting.
This article highlights the pharmacology of the medications commonly used for oral
conscious sedation in dentistry as well as clinical guidelines for administration.
Patient safety is the paramount consideration. Oral administration to achieve conscious
sedation requires state regulation to ensure safety.
Dental anxiety has been shown to be one of the biggest barriers for patients in seeking
needed care. An estimated 100 million people in the United States (approximately
30%) are in need of dental care but neglect the dental visit. A survey conducted
in the United States found that 18% of adults would visit the dentist more frequently
if they were given a drug to make them less nervous.1 With the strong need to treat
fearful and anxious adult patients, effective sedation and pain control have become
integral components of dental care.
General dental practitioners have used in-office oral sedation for more than 160 years
during routine dental practice. The oral route has remained the safest, most estab-
lished, and most commonly used route of drug administration. Advantages of the
oral route of drug administration in adults versus other routes of drug administration
include:
1. Lower incidence of adverse reactions
2. Decreased severity of adverse reactions
3. High degree of patient acceptance and compliance
4. Convenience of administration
a
Oral and Maxillofacial Surgery, The Brooklyn Hospital Center, 121 Dekalb Avenue, Brooklyn,
NY 11201, USA; b Oral and Maxillofacial Surgery, Department of Dentistry, The Brooklyn Hos-
pital Center, 121 Dekalb Avenue, Box 187, Brooklyn, NY 11201, USA
* Corresponding author.
E-mail address: hdymdds@yahoo.com
5. Low cost
6. Additional equipment or personnel not needed
Oral medications are well suited for anxiolysis (minimal sedation) and conscious
sedation (moderate sedation) in dentistry. Anxiolysis is a drug-induced state in which
patients respond appropriately to verbal commands. Although cognitive function
and coordination may be impaired, ventilatory and cardiovascular functions are unaf-
fected.2 Anxiolysis is the lightest level of sedation (Fig. 1).
Oral medication to achieve anxiolysis in adult patients seems to have a wide margin
of safety. When the intent is minimal sedation for adults, the appropriate initial dosing
of a single enteral drug is no more than the maximum recommended dose (MRD) of a
drug that can be prescribed for unmonitored home use.2 The MRD is the maximum US
Food and Drug Administration (FDA)–recommended dose of a drug as printed in FDA-
approved labeling for unmonitored home use. Incremental and supplemental dosing
both apply to the administration of minimal sedation. Incremental dosing is the admin-
istration of multiple doses of a drug until a desired effect is reached, but not to exceed
the MRD. During minimal sedation, supplemental dosing is a single additional dose of
the initial dose of the initial drug that may be necessary for prolonged procedures. The
supplemental dose should not exceed one-half of the initial total dose and should not
be administered until the dentist has determined that the clinical half-life of the initial
dosing has passed. The total aggregate dose must not exceed 1.5 times the MRD on
the day of treatment for minimal sedation.2 Regulatory agencies in all 50 United States
and Canada allow anxiolysis without an additional permit beyond completion of an
accredited predoctoral dental training program.
The American Dental Association (ADA) first developed clinical guidelines, including
educational requirements, for the use of sedation in dentistry in 1996 and most
recently released an update in 2012. In the 2012 ADA clinical guidelines, it is stated
that, “For all levels of sedation and anesthesia, dentists, who are currently providing
sedation and anesthesia in compliance with their state rules and/or regulations prior
to adoption of this document, are not subject to these educational requirements.
However, all dentists providing sedation and general anesthesia in their offices or
the offices of other dentists should comply with the Clinical Guidelines in this docu-
ment.”3 The 2012 ADA Clinical Guidelines for the Use of Sedation and General Anes-
thesia by Dentists state that to administer minimal sedation (anxiolysis) the dentist
must have successfully completed:
1. Training to the level of competency in minimal sedation consistent with that pre-
scribed in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists
and Dental Students, or a comprehensive training program in moderate sedation
that satisfies the requirements described in the Moderate Sedation section of the
ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental
Students at the time training was commenced; or
Fig. 1. The spectrum of sedation. (From Goodchild JH, Feck AS, Silverman MD. Anxiolysis in
general dental practice. Dent Today 2003;22(3):106–11; with permission.)
Oral Sedation in the Dental Office 297
Table 1
Triazolam (Halcion)
Diazepam (Valium) was synthesized in 1959 and marketed in 1963. Diazepam was
the leader among prescription drugs by the 1970s, and remained so until recently.
After oral administration, diazepam has an onset of about 1 hour, achieving 90% of
maximal clinical effect. Peak onset of plasma levels occurs within 2 hours. From the
presence of active metabolites and prolonged plasma half-life of 20 to 70 hours, a
long-lasting effect may occur with prolonged oral administration.5 Because of the
presence of active metabolites, patients may experience a hangover effect. Diazepam
is well tolerated in elderly patients. The recommended dose of diazepam for anxiolytic
premedication is 5 to 10 mg 1 hour before treatment. It is available in 2-mg, 5-mg, and
10-mg tablets and 10 mg/5 mL syrup (Table 2).
Lorazepam was marketed in 1977 under the trade name Ativan. The drawback to
the use of lorazepam is the longer onset time of 1 to 2 hours. Thus, administration
may be best suited for patients at home before the dental visit. Lorazepam has a pro-
found amnestic and effective antianxiety affect. Its usage is well tolerated in elderly in-
dividuals. Lorazepam is contraindicated in patients with narrow-angle glaucoma and
with a known allergy to benzodiazepines. Caution must be taken to not oversedate the
patient and in patients with a depressive disorder or psychosis. Reported side effects
include sedation (15.9%), dizziness (6.9%), weakness (4.2%), and ataxia (3.4%).5 For
preoperative anxiety control, a dose of 2 to 4 mg may be given or prescribed 1 to
2 hours before the dental appointment (Table 3).
Alprazolam (Xanax) is another benzodiazepine in the antianxiety drug class. It is most
commonly used for patients with panic-type anxiety. Alprazolam’s properties include
an onset time of 1 hour and duration of 1 to 2 hours. It is contraindicated in patients
with acute narrow-angle glaucoma and benzodiazepine allergy. Caution about intensi-
fied sedation is needed if coadministered with cytochrome P (CYP) 3A4 inhibitors.5
Alprazolam is available in 0.25-mg, 0.5-mg, and 1-mg tablets (Table 4).
Oxazepam was synthesized in 1961 and marketed in 1965 under the trade name
Serax. Oxazepam is desirable for use in patients with short-term anxiety. It has a rapid
onset, short elimination half-life of 5.7 to 10.9 hours, and no active metabolites.5 Oxaz-
epam is not affected by the CYP system, thus is less prone to undesirable drug inter-
actions. It has a low incidence of drowsiness and is a metabolite of valium. Oxazepam
is available in 10-mg, 15-mg, and 30-mg capsules and 15-mg tablets (Table 5).
Nonbenzodiazepine anxiolytics-hypnotics are chemically unrelated to other
sedative-hypnotics but have a pharmacologic effect similar to benzodiazepines.
These drugs are GABA receptor alpha-1 subunit agonists producing sedation and
Table 2
Diazepam (Valium)
Table 3
Lorazepam (Ativan)
Table 4
Alprazolam (Xanax)
Table 5
Oxazepam (Serax)
PATIENT EVALUATION
Patients considered for minimal sedation must be suitably evaluated before the start
of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this may
consist of a review of their current medical history and medication use.
However, patients with significant medical considerations (ASA III, IV)
may require consultation with their primary care physician or consulting medical
specialist.
PREOPERATIVE PREPARATION
The patient, parent, guardian, or care giver must be advised regarding the pro-
cedure associated with the delivery of any sedative agents and informed consent
for the proposed sedation must be obtained.
Table 6
Zolpidem (Ambien)
Documentation
An appropriate time-oriented anesthetic record must be maintained, including the
names of all drugs administered, including local anesthetics, dosages, and monitored
physiologic parameters.
EMERGENCY MANAGEMENT
If a patient enters a deeper level of sedation than the dentist is qualified to pro-
vide, the dentist must stop the dental procedure until the patient returns to the
intended level of sedation.
The qualified dentist is responsible for the sedative management; adequacy of
the facility and staff; diagnosis and treatment of emergencies related to the
administration of minimal and moderate sedation; and providing the equipment,
drugs, and protocol for patient rescue.3
Oral antianxiety drugs are administered by the dentist in a rationale technique. If
indicated, the dentist may prescribe a medication for the patient to take the night
before the appointment at bedtime. On the day of the appointment, if the patient is
deemed responsible, the prescribed drug may be taken by the patient at home,
304 Sebastiani et al
ideally 1 hour before (for most drugs) the appointment time, in which case a respon-
sible adult must escort the patient to the dental office. To ensure proper dosage and
time of administration, the dentist may administer the dose in the dental office
approximately 1 hour before the start of the dental appointment. After administration,
the patient should remain under constant supervision, ideally in the treatment room.
After 45 minutes, the dentist should evaluate the comfort level of the patient and the
efficacy of the oral drug, and make the clinical decision on when to proceed with
treatment.
If the current level of sedation produced by the oral medication is less than desired,
the dentist may introduce nitrous oxide-oxygen (N2O-O2). N2O-O2 may be used in com-
bination with a single enteral drug in minimal sedation. N2O-O2 when used in combina-
tion with sedative agents may produce minimal, moderate, or deep sedation, or general
anesthesia.2 The flow of N2O-O2 must be carefully titrated to the desired level of seda-
tion throughout the procedure. Vital signs are monitored and recorded every 5 minutes
on the anesthesia-sedation record. On termination of N2O-O2 use, the patient should
breathe 100% oxygen for a minimum of 5 minutes and recovery should be assessed.
Postoperative vital signs are documented on the anesthesia-sedation record. If
deemed ready for discharge, postoperative instructions should be read, and a written
copy given, to both the patient and the patient’s escort, who must be a responsible
adult. Later in the afternoon or evening the dentist or nurse should call the patient to
review postoperative instructions and answer any questions.
Adhering to state regulation of enteral administration of sedatives to achieve
conscious sedation, dentists may implement multidose enteral sedation. The Dental
Organization for Conscious Sedation (DOCS) has developed a multidose enteral seda-
tion protocol and educated more than 5000 dentists over the past several years. Pre-
operative and postoperative patient instructions are shown in Box 1.
The DOCS protocol is initiated with an oral dose of 0.25 mg of triazolam 1 hour
before the appointment by the patient at home. The dose is reduced to 0.125 mg in
Box 1
Preoperative and postoperative patient instructions
Preoperative
1. Take regular medications unless specified by physician or dentist
2. Do not eat or drink for 8 hours before the dental appointment
3. Patient must be driven to the office by a responsible companion
4. No smoking or drinking alcohol for 8 hours before the dental appointment
5. Sedative medications must be taken according to dentists’ instructions
Postoperative
1. Take all regular or prescribed medications as outlined by physician or dentist
2. No alcohol for 12 hours postsurgery
3. No driving for 12 hours postsurgery
4. Do not operate machinery for 12 hours postsurgery
5. Must have a responsible companion drive patient home and observe recovery
6. Phone number where dentist can be reached must be provided
From Goodchild JH, Feck AS, Silverman MD. Anxiolysis in general dental practice. Dent Today
2003;22(3):106–11; with permission.
Oral Sedation in the Dental Office 305
elderly patients or patients who are overly sensitive to benzodiazepines. The dentist
should assess the patient on arrival at the office. Assessment of the need for further
medication is conducted with the dentist sitting at eye level with the patient and asking
the patient to rate the level of sedation using a 10-point scale (1 5 relaxed,
10 5 excited).1 The patient’s quality and speed of speech as well as the patient’s abil-
ity to make eye contact should be evaluated. The patient should be asked by the
dentist whether more sedation is desired. No additional medication should be admin-
istered when acceptable sedation is achieved. Table 7 shows the DOCS criteria for
administering additional oral medication.
The patient should be monitored for heart rate and oxygen saturation continu-
ously and blood pressure at 5-minute intervals. Reassessment of the patient’s level
of sedation should be conducted after 30 to 45 minutes, and additional sublingual
triazolam administered if necessary. The goal of incremental dosing is to achieve
the lowest dose for a comfortable patient experience during treatment. Per the
DOCS protocol, before administering the local anesthetic, 20% to 30% nitrous ox-
ide should be introduced.1 The nitrous oxide should then be discontinued and the
dental procedure started. Patient monitoring should occur every 5 minutes,
including verbal responsiveness. For treatment longer than 2 hours in which the
dentist and patient agree that the level of sedation is inadequate, additional triazo-
lam can be administered to the patient.
In case of an overdose emergency, use of a pharmacologic antagonist (reversal
drug) must never be substituted for maintenance of the airway and ventilation with
100% oxygen. Flumazenil (Romazicon) is the benzodiazepine reversal agent, and it
competes with benzodiazepines for the receptor site (competitive inhibition). Fluma-
zenil is used to reverse CNS and respiratory depressant effects and decrease recov-
ery time. It possesses a short half-life resulting in short duration. Do not be hesitant
to use flumazenil if you are having trouble getting patients to respond to verbal com-
mands or the constant physiologic monitoring indicates a trend toward nonmanage-
able oxygen desaturation.7 Readministration may be necessary because resedation
can occur, especially if the benzodiazepine has a long-acting effect. It is prudent to
keep and monitor the patient for resedation at least an hour after flumazenil reversal
use.
Flumazenil administered by IV, sublingual, intramuscular, and rectal routes reversed
midazolam-induced respiratory depression in a dog model.8 The IV route was signif-
icantly faster than the other routes (120 seconds vs 262 seconds with the sublingual
route). There was no significance between the non-IV routes. Flumazenil 0.2 mg by
submucosal injection into the maxillary posterior vestibule produced an incomplete
and transient attenuation of moderate/deep sedation produced by incremental sublin-
gual doses of triazolam.9 It takes approximately a 1 mg submucosal administration of
Table 7
DOCS criteria for administering additional oral medication
Recommended
Patient Response Sublingual Dose (mg)
Clear response, high scale rating, good eye contact and posture Triazolam 0.5
Clear, but slightly delayed response and moderate eye contact Triazolam 0.25
Slightly slurred and delayed response, inconsistent eye contact Triazolam 0.125
Slurred and delayed response, quiet and confused, no eye contact No additional medication
Table 8
Flumazenil (Romazicon)
Although many enteral drugs are available for the sedation of children, the senior
author (HD) agrees with the many studies found in the literature that oral midazolam
at a dose of 0.5 mg/kg is ideal and will provide safe and effective sedation for most
children requiring minor procedures, with few to no side effects.12
When oral conscious sedation is used within the standards of care, the interests of
the public and the dental profession are served through a cost-effective service that
can be widely available. Oral sedation will continue to enable dentist to provide dental
care to millions of individuals who otherwise would have unmet dental needs.
SUMMARY
Enteral sedation is a useful adjunct for the dental treatment of both anxious adults
and pediatric patients. General dentists and specialists must be knowledgeable in
the pharmacology of the medications currently available along with their potential
risks and benefits.
REFERENCES
1. Dionne RA, Yagiela JA, Coté CJ, et al. Balancing efficacy and safety in the use of
oral sedation in dental outpatients. J Am Dent Assoc 2006;137(4):502–13.
2. American Dental Association. Guidelines for teaching pain control and sedation
to dentists and dental students. ADA House of Delegates. Chicago: American
Dental Association; 2007.
3. American Dental Association. Guidelines for the use of conscious sedation, deep
sedation and general anesthesia for dentists. Chicago: American Dental Associ-
ation; 2012.
4. American Dental Association and Department of State Government
Affairs. Conscious sedation permit requirement. Available at: http://www.ada.
org/w/media/ADA/Advocacy/Files/anesthesia_sedation_permit.ashx. Accessed
September 2, 2009.
5. Malamed SF. Sedation: a guide to patient management [Print]. 5th edition. St Louis
(MO): Mosby; 2009.
6. Giovannitti JA, Trapp LD. Adult sedation: oral, rectal, IM, IV. Anesth Prog 1991;
38(4–5):154–71.
7. Goodchild JH, Feck AS, Silverman MD. Anxiolysis in general dental practice.
Dent Today 2003;22(3):106–11.
8. Heniff MS, Moore GP, Trout A, et al. Comparison of routes of flumazenil adminis-
tration to reverse midazolam-induced respiratory depression in a canine model.
Acad Emerg Med 1997;4:1115–8.
9. Hosaka K, Jackson D, Pickrell JE, et al. Flumazenil reversal of sublingual triazo-
lam. A randomized controlled clinical trial. JADA 2009;140:559–66.
10. Chowdhury J, Vargas KG. Comparison of chloral hydrate, meperidine, and
hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients.
Pediatr Dent 2005;27(3):191–7.
11. Lourenço-Matharu L, Ashley PF, Furness S. Sedation of children undergoing
dental treatment. Cochrane Database Syst Rev 2012;(3):CD003877.
12. Davies FC, Waters M. Oral midazolam for conscious sedation of children during
minor procedures. J ACCID Emerg Med 1998;(4):244–8.