A review of adverse sedation events and AAPD guidelines

Stephanie Parker, DDS First Year Resident Pediatric Dentistry

Adverse sedation events in pediatrics: a critical incident analysis of contributing factors

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Charles Cote, Daniel Notterman, Helen Karl, Joseph Weinberg, Carolyn McCloskey Pediatrics 2000;105:805-14 Objective: To investigate factors contributing to adverse sedation outcomes, using critical incident analysis Methodology: Authors developed a database of adverse sedation events from the following three sources: (1) FDA adverse drug reaction reporting system, (2) US Pharmacopeia, (3) specialists survey (ED, anesthesia, intensivists)

Adverse sedation events, continued Cote

et al, Pediatrics 2000;105:805

Methodology, continued: 118 reports were complete enough for review. Possible outcomes were: death, permanent neurologic injury, prolonged hospitalization, or no harm. Four physicians independently reviewed each case. Results: Only 95 reports were totally agreed upon by all four reviewers. 51 cases resulted in death 9 resulted in permanent neurologic injury 21 in prolonged hospitalization 14 experienced no harm

Adverse sedation events, continued Cote

et al, Pediatrics 2000;105:805
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Results, continued: Children receiving sedation in nonhospital settings were older and healthier than in hospitals. No difference in location/venue was found for respiratory events (e.g., desaturation). Cardiac arrest was more often the second event in nonhospital settings. Failure to resuscitate was more often a factor outside the hospital. Death and permanent injury occurred more outside the hospital setting. Pulse oximetry was associated with better outcomes and far better outcomes in hospitals.

Adverse sedation events, continued Cote

et al, Pediatrics 2000;105:805
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Conclusions and Discussion: Better outcomes occurred in hospital-based settings. Inadequate resuscitation was more often associated with a non-hospital-based setting. Other problem causes were inadequate presedation evaluation, lack of an independent observer, medication errors and inadequate recovery procedures. Health care providers should have advanced airway management skills, have age-appropriate equipment and medications.

AAPD Sedation Guidelines

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5 functional levels of sedation

 I - anxiolysis  II - interactive  III - non-interactive, arousable with

mild/moderate stimuli  IV - non-interactive, arousable with intense stimuli  V - GA

AAPD Sedation Guidelines

Level I Awake Clinical Observation PO; Pre-C Desirable No record needed HR, RR, O2 q15m

Level II

Drowsy

Level III

Eyes closed; arousable

PO; Pre-C; BP; HR, RR, O2 , Capno Desirable BP q10m HR, RR, O2 , BP, CO2 q5m HR, RR, O2 , BP, CO2 Temp, q5m

Level IV

Level V

Difficult to arouse PO; Pre-C; BP; Capno, ECG, Defib Desirable Unresponsive PO; Pre-C; BP; Capno, ECG, Temp, Defib

Facilities & Equipment

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Newly installed facilities must be checked for proper gas delivery & fail-safe function. N2O capable of 100% O2 and never less than 25% O2; otherwise need in-line O2 analyzer. Positive pressure O2 (> 90% [conc]) at 10 L/min flow (15L/min with anesthesia bag) for minimum of 1 hr (650 L, E cylinder). Functional suction Appropriate monitors & all equipment should accommodate children of all ages & sizes. Emergency kit must be available & drugs should be available to resuscitate non-breathing patient.

AAPD Sedation Guidelines

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Pre-Procedural Prescriptions
 only minor tranquilizers (e.g.,

hydroxyzine or diazepam) can be administered outside of treatment facility.

 chloral hydrate or meperidine

cannot

be administered outside of treatment facility.

ADA Guidelines
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Two broad areas: educational requirements & clinical guidelines Areas/type of sedation covered
Combination inhalation-enteral

conscious sedation (exception: anxiolysis only) Parenteral conscious sedation Deep sedation/general anesthesia

Educational Requirements
Type of Sedation Guidelines for teaching comprehensive control of pain & anxiety in dentistry Completed accredited postdoc program Grandfathering

Combination Inhalation-Enteral Conscious Sedation Parenteral Conscious Sedation Deep Sedation/GA

I or III

Yes

Yes

III

Yes

Yes

II

Yes

Yes

Clinical Requirements
Type of Sedation Combo-Inhalation Enteral Conscious Sedation Parenteral Conscious Sedation Personnel 2 Equipment fail-safe system; >75% N2O requires O2 analyzer; scavenging Monitor clinical observation; PO, pre-cordial (q15min) Special Considerations None

fail-safe system; clinical >75% N2O requires observation; PO, HR, BP EKG if O2 analyzer; significant scavenging; positive cardiovascular pressure O2; IV line disease (q10min) needed*** Fail-safe system; >75% N2O requires O2 analyzer; scavenging; positive pressure O2; IV line needed***; advanced airway management Monitor: clinical observation; PO, HR, BP, CO2, EKG, Temp (all q5min), defibrillator

No IV needed for short procedures, young children, IV can be started after sedation begins

Deep Sedation/GA

IV can be started after sedation begins; for extremely brief procedures, no IV needed; ACLS drugs & equipment needed