Oral Sedation in the Dental Office

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Oral Sedation in the Dental Office Francesco R. Sebastiani,

DMD

a

, Harry Dym,

DDS

b,

*, Joshua Wolf,

DDS

a

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 established, 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. 2. 3. 4.

Lower incidence of adverse reactions Decreased severity of adverse reactions High degree of patient acceptance and compliance 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 Hospital Center, 121 Dekalb Avenue, Box 187, Brooklyn, NY 11201, USA * Corresponding author. E-mail address: [email protected]

Dent Clin N Am 60 (2016) 295–307 http://dx.doi.org/10.1016/j.cden.2015.11.002 dental.theclinics.com 0011-8532/16/$ – see front matter Ó 2016 Elsevier Inc. All rights reserved.

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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 unaffected.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 FDAapproved labeling for unmonitored home use. Incremental and supplemental dosing both apply to the administration of minimal sedation. Incremental dosing is the administration 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 document.”3 The 2012 ADA Clinical Guidelines for the Use of Sedation and General Anesthesia 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 prescribed 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

2. An advanced education program accredited by the ADA Commission on Dental Accreditation that affords comprehensive and appropriate training necessary to administer and manage minimal sedation commensurate with these guidelines; and 3. A current certification in Basic Life Support (BLS) for Healthcare Providers Administration of minimal sedation by another qualified dentist or independently practicing qualified anesthesia health care provider requires operating dentists and their clinical staff to maintain current certification in Basic Life Support for Healthcare Providers.2 Conscious sedation is defined as, “a minimally depressed level of consciousness that retains the patient’s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command and that is produced by a pharmacological or non-pharmacological method or a combination thereof.”3 All patients pass through anxiolysis before entering conscious sedation. The same drugs that are prescribed for anxiolysis produce oral conscious sedation usually at a dosage greater than 1.5 times the FDA-approved maximum recommended dosage or in combination with other central nervous system (CNS)–altering medications. According to the 2012 ADA Clinical Guidelines for the Use of Sedation and General Anesthesia by Dentists to administer moderate (conscious) sedation dentists must have successfully completed: 1. 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 2. An advanced education program accredited by the ADA Commission on Dental Accreditation that affords comprehensive and appropriate training necessary to administer and manage moderate sedation commensurate with these guidelines; and 3. (i) A current certification in Basic Life Support for Healthcare Providers and (ii) either current certification in advanced cardiac life support (ACLS) or completion of an appropriate dental sedation/anesthesia emergency management course on the same recertification cycle that is required for ACLS Administration of moderate sedation by another qualified dentist or independently practicing qualified anesthesia health care provider requires the operating dentist and his/her clinical staff to maintain current certification in Basic Life Support for Healthcare Providers.3 Per state regulation, oral conscious sedation (moderate sedation) may be safely and effectively administered in the dental office. New York state requirements for a Dental Enteral Conscious Sedation Certificate include 20 clinically oriented experiences in the use of enteral conscious sedation techniques; 18 hours of training, including but not limited to instruction in nitrous oxide and emergency medicine; BLS; and 6 hours of continuing education.4 In addition, a minimum of 2 individuals must be present in the operatory; such individuals must include the dentist and 1 additional qualified individual. In New York and specified other states, the dentist shall not administer conscious sedation (enteral or parenteral) to more than 1 patient at a time. Six hours of training every 3 years is required for the dentist to renew an oral sedation permit in New York. American dentists can find state-specific regulations at the following link to the chart of state statutory requirements for conscious sedation permits provided by

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the ADA: http://www.ada.org/w/media/ADA/Advocacy/Files/anesthesia_sedation_ permit.ashx. Benzodiazepines are the preferred drugs for the management of dental fear and preoperative anxiety. Benzodiazepines are anxiolytic, have sedative properties, and produce anterograde amnesia. These drugs are indicated for the management of mild to moderate anxiety. Benzodiazepines act by facilitating the physiologic inhibitory effects of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter in the brain.5 Benzodiazepines have a high therapeutic index (ratio of the toxic dose of a drug to its therapeutic dose), and therefore possess a high margin of safety, which is the primary advantage compared with other classes of sedativehypnotics, especially the barbiturates, which have a much lower therapeutic index. Benzodiazepines have proved to be fairly innocuous in intentional or accidental overdose when taken without additional drugs.6 Benzodiazepines are effective as single agents, thus drug cocktails are not necessary. Benzodiazepines vary by onset time, duration, metabolism, and in degree of sedation. Triazolam, diazepam, lorazepam, and alprazolam are the most effective and commonly administered benzodiazepines for anxiolysis and conscious sedation in dentistry.6 Triazolam (Halcion) was first introduced in the 1980s. It is the most prescribed psychoactive drug and the most popular drug prescribed by dentists to alleviate pretreatment patient anxiety in the United States. Triazolam has been described as a nearly ideal anxiolytic for oral sedation in dentistry because of its short half-life of 1.5 to 5.5 hours and absence of active metabolites.6 A high level of sleep and amnesic effect is produced by triazolam, with little residual drowsiness or hangover effect. Triazolam has about a 45% bioavailability and an onset of action of approximately 1 hour. If administered sublingually, the rate of onset is improved to about 30 minutes and bioavailability is increased. The reported duration of triazolam is an average 1 to 2 hours.5 Triazolam is available in 0.125-mg and 0.25-mg tablets. The average dose is 0.25 mg and the FDA MRD is 0.5 mg. As pregnancy category X, triazolam is contraindicated in pregnant patients.5 Caution should be taken when using it in the elderly or debilitated because excessive sedation is possible. The initial recommended dose in elderly patients is 0.125 mg. Overdose may occur at 4 times the MRD of 0.5 mg, which is 2 mg or 8 tablets (0.25 mg) (Table 1).

Table 1 Triazolam (Halcion) Dose (mg)

0.25–0.5 Average: 0.25 MRD: 0.5

Onset

1h 30 min; sublingual

Duration (h)

1–2

Contraindications

Pregnancy

Precautions

Excessive sedation possible in elderly

Availability

Tablets: 0.125, 0.25 mg

Active Metabolites

None

Pregnancy Category

X

Classification

Sedative/hypnotic

Oral Sedation in the Dental Office

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 profound amnestic and effective antianxiety affect. Its usage is well tolerated in elderly individuals. 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 intensified 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 Oxazepam is not affected by the CYP system, thus is less prone to undesirable drug interactions. 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) Dose (mg)

2–20

Onset (h)

1

Duration (h)

1–3

Contraindications

Allergy, acute narrow-angle glaucoma

Precautions

Sedation intensified with CYP3A4 and CYP2C19 inhibitors

Availability

Tablets: 2, 5, 10 mg Syrup: 10 mg/5 mL

Active Metabolites

Yes

Pregnancy Category

D

Classification

Antianxiety

Abbreviation: CYP, cytochrome P.

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Table 3 Lorazepam (Ativan) Dose (mg)

2–4

Onset (h)

1–2

Duration (h)

2–4

Contraindications

Allergy, acute narrow-angle glaucoma

Precautions

Oversedation, depressive disorders, psychosis

Availability

Tablets: 0.5, 1, 2 mg

Active Metabolites

None

Pregnancy Category

D

Classification

Antianxiety Sedative/hypnotic

amnesia. The amnestic effect is not as profound as that produced by benzodiazepines. Nonbenzodiazepine anxiolytics-hypnotics produce less memory and cognitive impairment than benzodiazepines. They are biotransformed by several CYP enzymes in addition to CYP3A4, thus CYP3A4 inhibitors and inducers have a lesser effect.5 Zolpidem, zaleplon, and ezopiclone are effective nonbenzodiazepine anxiolyticshypnotics used in dentistry. Zolpidem (Ambien) is a nonbenzodiazepine sedative-hypnotic approved for use in the United States in 1993. It is a strong sedative with mild anxiolytic, myorelaxant, and anticonvulsant properties. Zolpidem is the drug of choice for pregnant patients.6 It has been proved to be effective in inducing and maintaining sleep in adults. Zolpidem is rapidly absorbed from the gastrointestinal tract, with an onset of action of approximately 1 hour and peak effect in 1.6 hours. There is an increased risk of further depressed respiratory drive if zolpidem is used in patients with compromised respiratory function. There has been reported a slightly greater than 3% risk of dizziness, headache, allergy, back pain, drowsiness, lethargy, nausea, dyspepsia, diarrhea, myalgia, arthralgia, and dry mouth with zolpidem use.5 Dose in adults is 5 to 10 mg by mouth; an initial dose of 5 mg orally is recommended in elderly and debilitated patients because of increased sensitivity (Table 6). Zaleplon (Sonata) is an additional nonbenzodiazepine, imidazopyridine class sedative-hypnotic. Zaleplon is similar to zolpidem both pharmacologically and pharmacokinetically. Zaleplon should be used with a high degree of caution in imidazopyridine class hypersensitivity, impaired hepatic function, and elderly and pregnant Table 4 Alprazolam (Xanax) Dose (mg)

0.25–1

Onset (h)

1

Duration (h)

1–2

Contraindications

Allergy, acute narrow-angle glaucoma

Precautions

Sedation intensified with CYP3A4 inhibitors

Availability

Tablets: 0.25, 0.5, 1 mg

Active Metabolites

None

Pregnancy Category

D

Classification

Antianxiety

Oral Sedation in the Dental Office

Table 5 Oxazepam (Serax) Dose (mg)

10–30

Onset (h)

1

Duration (h)

2–4

Contraindications

Allergy

Precautions

Elderly, debilitated patients

Availability

Capsules: 10, 15, 30 mg Tablets: 15 mg

Active Metabolites

None

Pregnancy Category

D

Classification

Antianxiety

patients. Common adverse reactions include drowsiness, amnesia, paresthesias, abnormal vision, dizziness, headache, hangover effect, rebound insomnia, and confusion.5 Adult dose is 5 to 10 mg by mouth; it is available in 5-mg and 10-mg capsules. Anxiolysis and enteral conscious sedation both require evaluation of patients, monitoring, documentation, facilities, equipment, and personnel requirements as described in ADA guidelines. The following are the 2012 ADA clinical guidelines for minimal sedation, with additions specifically stated for moderate sedation. 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 procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained. Table 6 Zolpidem (Ambien) Dose (mg)

5–10

Onset (h)

1

Duration (h)

2–3

Contraindications

Allergy

Precautions

Reduce dose in elderly

Availability

Tablets: 5, 10 mg

Active Metabolites

None

Pregnancy Category

B

Classification

Sedative/hypnotic

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 Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed (Ambu bag, Oxygen).  Baseline vital signs must be obtained unless the patient’s behavior prohibits such determination.  A focused physical evaluation must be performed as deemed appropriate.  Preoperative dietary restrictions must be considered based on the sedative technique prescribed.  Preoperative verbal and written instructions must be given to the patient, parent, escort, guardian, or care giver. PERSONNEL AND EQUIPMENT REQUIREMENTS

Personnel:  At least 1 additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist. Equipment:  A positive pressure oxygen delivery system suitable for the patient being treated must be immediately available (Ambu bag, Oxygen).  When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm.  An appropriate scavenging system must be available if gases other than oxygen or air are used.  For moderate sedation, the equipment necessary to establish intravenous (IV) access must be available.

MONITORING AND DOCUMENTATION Monitoring for Minimal Sedation

A dentist or, at the dentist’s direction, an appropriately trained individual must remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring for Moderate Sedation

A qualified dentist administering moderate sedation must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. When active treatment concludes and the patient recovers to a minimally sedated level a qualified auxiliary staff may be directed by the dentist to remain with and continue to monitor the patient as explained in the guidelines until the patient is discharged from the facility. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring must include:  Consciousness: Level of consciousness (eg, responsiveness to verbal command) must be continually assessed.  Oxygenation: Color of mucosa, skin, or blood must be evaluated continually.

Oral Sedation in the Dental Office

Oxygen saturation by pulse oximetry may be clinically useful and should be considered for minimal sedation. For moderate sedation, oxygen saturation must be evaluated by pulse oximetry continuously.  Ventilation for minimal sedation: The dentist and/or appropriately trained individual must observe chest excursions continually. The dentist and/or appropriately trained individual must verify respirations continually.  Ventilation for moderate sedation: The dentist must observe chest excursions continually. The dentist must monitor ventilation. This monitoring can be accomplished by auscultation of breath sounds, monitoring end-tidal CO2, or by verbal communication with the patient.  Circulation: Blood pressure and heart rate should be evaluated preoperatively, postoperatively, and intraoperatively as necessary. 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. RECOVERY AND DISCHARGE

 Oxygen and suction equipment must be immediately available if a separate recovery area is used.  The qualified dentist or appropriately trained clinical staff must monitor the patient during recovery until the patient is ready for discharge by the dentist.  The qualified dentist must determine and document that the level of consciousness, oxygenation, ventilation, and circulation are satisfactory before discharge.  Postoperative verbal and written instructions must be given to the patient, parent, escort, guardian, or care giver.  If a pharmacologic reversal agent is administered before discharge criteria have been met, the patient must be monitored for a longer period than usual before discharge, because resedation may occur once the effects of the reversal agent have waned. EMERGENCY MANAGEMENT

 If a patient enters a deeper level of sedation than the dentist is qualified to provide, 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,

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ideally 1 hour before (for most drugs) the appointment time, in which case a responsible 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 combination with a single enteral drug in minimal sedation. N2O-O2 when used in combination 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 sedation 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 sedation protocol and educated more than 5000 dentists over the past several years. Preoperative 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.

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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 ability 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 administered 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 continuously 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 oxide 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 triazolam 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). Flumazenil is used to reverse CNS and respiratory depressant effects and decrease recovery 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 commands or the constant physiologic monitoring indicates a trend toward nonmanageable 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 significantly 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 sublingual doses of triazolam.9 It takes approximately a 1 mg submucosal administration of

Table 7 DOCS criteria for administering additional oral medication Patient Response

Recommended 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 Overdose may develop at 4X MRD of Triazolam.

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flumazenil to be as effective as a 0.2-mg IV administration. This amount equates to about 5 carpules of local anesthetic (Table 8). Oral sedatives can also have an important role in treating children. For most patients, acceptable behavior can be achieved by traditional nonpharmacologic management techniques; however, for a small percentage of patients, oral sedatives can help behavior management and anxiety issues. The primary use of pharmacologic sedation in children is similar to that in adults. It also includes minimizing the negative psychological response to treatment by reducing anxiety and minimizing the longterm negative psychological feelings about dentistry. Many drugs are available for children for the relief of anxiety through oral administration and must be given in amounts depending on the patient’s weight and the comfort level of the practitioner. Many of these drugs have also been given in combinations. Some of the most common drugs are drugs given to adult patients, including midazolam, tramadol, meperidine, and zolpidem. Hydroxyzine is one of the antihistaminic drugs used for its sedative effect alone before a dental procedure.10 All of the oral sedatives can also be combined with nitrous oxide for increased effect. In a Cochrane Review, the range of dosages of oral midazolam cited in the literature was from 0.2 mg/kg to 1 mg/kg, whereas the range of chloral hydrate was from 40 mg/kg to 70 mg/kg. The study concluded that dosages, mode of administration, and time of administration varied widely in the literature regarding sedation in dental patients and the best evidence, although weak, was for oral midazolam as an effective sedative agent for children undergoing dental treatment in doses between 0.25 mg/kg and 0.75 mg/kg.11 When dealing with sedatives and children, practitioners should understand the differences in airway anatomy and physiology between children and adult patients in emergencies (which is beyond the scope of this article) and be prepared with the appropriate-sized equipment. Dental practitioners using oral sedation in children must be vigilant to the possibility of hypoxemia because of the reduced oxygen reserve in children versus adults. Pulse oximetry must be used and frequent ongoing monitoring performed. Similar to adult patients, children require all the essential items and requirements as noted earlier regarding preoperative evaluation, intraoperative monitoring, and postprocedure discharge evaluation. However, dental offices engaged in the enteral sedation of children must be equipped with the appropriate child-sized resuscitation equipment, including oral and nasal airways, laryngeal mask airways, endotracheal tubes, laryngoscopes, and full-face mask ambu bags. Table 8 Flumazenil (Romazicon) Dose (mg)

0.2 IV (over 15 s) or Sublingual

Additional Dose (mg)

0.2 IV or IM

Maximum Dose

1.0 (5 doses)

Sublingual Location

0.2mg (0.1mg/cc) initial dose 2-3 mm under mucosa just off midline under tongue into venous plexus, 2nd dose in 2-3 min (if needed)

Adverse Effects

Agitation, confusion, dizziness, nausea

Precautions

May precipitate withdrawal syndrome (chronic benzodiazepine use). May produce seizures and cardiac dysrhythmias with tricyclic antidepressants

Availability

0.1 mg/mL IV solution (10 mL maximum)

Abbreviation: IM, intramuscular.

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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

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