Oral Anxiolysis, Minimal Sedation, and Nitrous Oxide

Subject: III. Clinical - A. Anesthesia

Department: Clinical Affairs

Origination Date: 12/04/2013

Reviewed and/or Revised: 09/01/2017, 05/16/2022, 09/27/2023, 02/20/2024, 09/18/2024

Purpose: To ensure safe use of Oral anxiolysis/minimal sedation, and Nitrous Oxide

Definitions:

Minimal Sedation – a minimally depressed level of consciousness, produced by a pharmacological method, that retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected.

Note: In accord with this particular definition, the drug(s) and/or techniques used should carry a margin of safety wide enough never to render unintended loss of consciousness. Further, patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of minimal sedation.

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.

The use of preoperative sedatives for children (aged 12 and under) except in extraordinary situations must be avoided due to the risk of unobserved respiratory obstruction during transport by untrained individuals.

Children (aged 12 and under) can become moderately sedated despite the intended level of minimal sedation; should this occur, the guidelines for moderate sedation apply.

For children 12 years of age and under, the American Dental Association supports the use of the American Academy of Pediatrics/American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.

Nitrous oxide/oxygen may be used in combination with a single enteral drug in minimal sedation.

Nitrous oxide/oxygen when used in combination with sedative agent(s) may produce minimal, moderate, deep sedation or general anesthesia.

1 Portions excerpted from Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia , 2004, of the American Society of Anesthesiologists (ASA). A copy of the full text can be obtained from ASA, 520 N. Northwest Highway, Park Ridge, IL 60068-2573.

The following definitions apply to administration of minimal sedation:

maximum recommended (MRD) – maximum FDA-recommended dose of a drug, as printed in FDA-approved labeling for unmonitored home use.

incremental dosing – administration of multiple doses of a drug until a desired effect is reached, but not to exceed the maximum recommended dose (MRD).

supplemental dosing - 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 dose and should not be administered until the dentist has determined the clinical half-life of the initial dosing has passed. The total aggregate dose must not exceed 1.5x the MRD on the day of treatment.

Anxiolysis.

A permit is not required for a dentist to administer anxiolysis.
A dentist who intends to administer anxiolysis shall indicate the intent to administer anxiolysis in the patient's records.
A dentist who administers anxiolysis may not administer a dose that is inappropriate for a patient's:
(1) Age; (2) Weight; (3) Medical condition; (4) Infirmities; or (5) Other propensities.
Medications used to produce anxiolysis may not exceed current limits set by the manufacturer for unmonitored use by the individual.
A dentist who administers anxiolysis shall maintain a margin of safety and a level of consciousness that does not approach moderate sedation and other deeper states of sedation and general anesthesia.

Policy and/or Procedure:

1. Nitrous oxide use must be approved by attending/covering faculty who must also be present in close proximity during use.

To administer minimal sedation 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
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 for Healthcare Providers.
Administration of minimal sedation by another qualified dentist or independently practicing qualified anesthesia healthcare provider requires the operating dentist and his/her clinical staff to maintain current certification in Basic Life Support for Healthcare Providers.

2. Patient Evaluation

Patients considered for minimal sedation must be suitably evaluated prior to 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.

3. Pre-Operative 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.
Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed.
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.
Pre-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.

4. Personnel and Equipment Requirements

Personnel:

At least one 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.
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.

5. Monitoring and Documentation

Monitoring: 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 must include:

Oxygenation:
- Color of mucosa, skin or blood must be evaluated continually.
- Oxygen saturation by pulse oximetry may be clinically useful and should be considered.
Ventilation:
- The dentist and/or appropriately trained individual must observe chest excursions continually.
- The dentist and/or appropriately trained individual must verify respirations continually.
Circulation:
- Blood pressure and heart rate should be evaluated pre-operatively, post-operatively and intra-operatively as necessary (unless the patient is unable to tolerate such monitoring).

Documentation: An appropriate sedative record must be maintained, including the names of all drugs administered, including local anesthetics, dosages, and monitored physiological parameters.

6. Recovery and Discharge

Oxygen and suction equipment must be immediately available if a separate recovery area is utilized.
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 level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge.
Post-operative verbal and written instructions must be given to the patient, parent, escort, guardian or care giver.

7. 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 sedation and providing the equipment and protocols for patient rescue.

8. Management of Children