Christopher Watson, MD, MPHMedical Director, Pediatric Sedation UnitWalter Reed NMMC – Bethesda September 2011

I’m a provider in clinic. I want to schedule a study for a patient which may need sedation. What do I do?

Call Patrick Provencio at 301-400-1594

Call Naomi Osborne at 301-400-2030

Email Patrick and Naomi: patrick.provencio@med.navy.mil and naomi.osborne@med.navy.mil

That’s it. The rest of this for those who

are actually doing the sedations!

I’m on the ward and a patients needs a sedated procedure/study. What do I do?

During normal duty hours:

1st preference is to check with the PSU

2nd preference depending on study/availability is anesthesia (Call Mr. Provencio at 400-1594 to book in S3)

3rd option is to transfer to the PICU

After hours (non-elective procedures/studies only):

1st preference: Anesthesia on-call

2nd preference: Transfer to PICU for sedation

The purpose of this course is to provide you with the tools and information you need to effectively sedate pediatric patients and manage pain while minimizing risk and maximizing safety.

After completing this course you will be able to:Better understand Moderate Sedation policies at WR-BethesdaProperly screen patients and perform pre-sedation history and examinationsUnderstand the importance of documentation before, during, and after a procedureList pre-procedure fasting guidelinesMinimize risk by utilizing aspiration prophylaxis protocolsKnow when to monitor and which monitoring aids to useIdentify the causes and treatments of airway compromiseSelect appropriate drugs and routes of administration for the provision of moderate sedationManage procedural and post-procedure pain

A 4-year-old boy fell of his bicycle and suffered a facial laceration requiring suturing.

First restraint is tried…This only reinforces negative perceptions of pain control and may amplify the traumatic injury to the child.

Now the patient is uncooperative, agitated, and sweating profusely. He is “consciously sedated” in the emergency department with:

KetamineMidazolamAtropineLocal lidocaine-epinephrine-tetracaine (LET)Propofol

…But in reality, this scenario has now progressed to general anesthesia!

Consider: Was this preventable? How else could the sedation been pursued?

A 2-year-old with developmental delay and a history of seizures requires a computed tomography (CT) scan as part of the diagnostic workup. Chloral hydrate sedation initially produced agitation.

Sedation occurred only after the procedure was cancelled.

Consider: Was this unexpected? Would a better pharmacology understanding have helped?

They reinforce the need for those of us involved in pediatric sedation to better understand the indications, patient requirements, safety measures, and sedative properties in order to ensure appropriate, safe, and effective provision of sedation.

And so we begin…

In the past, the challenge was a lack of uniformity in terminology. Every organization had their own definitions:

American Academy of Pediatrics (AAP)American Society of Anesthesiologist (ASA)American Academy of Pediatric Dentists (AAPD)The Joint Commission

With recent standardization across these organizations, we all now use the same language with regards to pediatric sedation.

As part of the standardization, the use of the term “conscious sedation” has actually been abandoned.

Minimal Sedation

(Anxiolysis)

ModerateSedation / Analgesia

Deep Sedation / Analgesia

General Anesthesia

Responsiveness Normal response to verbal

stimulation

Purposeful* response to

verbal or tactilestimulation

Purposeful* response after

repeated or painful

stimulation

Unarousable, even with

painful stimulus

Airway Unaffected No intervention required

Intervention may be required

Intervention often required

Spontaneous ventilation

Unaffected Adequate May be inadequate

Frequently inadequate

Cardiovascular function

Unaffected Usually maintained

Usually maintained

May be impaired

* Reflex withdrawal from a painful stimulus is not considered a purposeful response.

American Society of Anesthesiologists. Anesthesiology 2002; 96:1004–17.

None Minimal Moderate Deep GeneralAnesthesia

2yo Head CT

4yo BM Biopsy

9yo Colonoscopy

As sedation providers, we must be acutely aware of the dangers

represented here. The transition between stages may not be

obvious. We always need to be prepared to handle the next level!

Minimal sedation / anxiolysis is a drug induced state during which patients can respond normally to verbal commands. Ventilation and cardiovascular function are unaffected. Typically, a low dose of one drug given once with no loss of consciousness is recommended.The intent is little sedative effect. This is rarely our goal….

In moderate sedation the practitioner titrates sedatives or combinations of sedatives and analgesics to produce a desired effect.Drug-induced depression of consciousness in which patients respond either alone or accompanied with light tactile stimulation.

Arbitrarily we say that any time a second drug or dose is added, it is MSA. Really it’s based on effect.

The airway and spontaneous ventilation are adequate; cardiovascular function is maintained.Can be safely performed by pediatricians, family practitioners and mid-level providers (PA/PNP).

In DSA, sedatives or combinations of sedatives, analgesics, and anesthetizing agents are titrated to produce a drug-induced depression of consciousness.Patients do not respond purposefully to verbal command or light touch, but do respond purposefully following repeated or painful stimulation.May require assistance in maintaining a patent airway. Spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.Deep Sedation / Analgesia requires critical care or anesthesia training.

A drug induced loss of consciousness during which patients are not arousable, even by painful stimuli. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because depressed ventilation or drug induced impairment of neuromuscular function.Cardiovascular function may be impaired.

Painful procedures (or non-painful procedures requiring complete immobility) cannot realistically be performed in children (and many adults) who are moderately sedated.In moderate sedation, the response to painful stimulus is to say “ouch,” push away the stimulus, hide, or attempt flight – conditions that are inadequate for many procedures.And so, we need to be cognizant that achieving obliteration of reflex withdrawal actual means we’ve crossed into deep sedation.

In patients of any age, even if the practitioner attempts moderate sedation, it can rapidly and unpredictably become deep sedation or general anesthesia.Unlike adults, deep sedation is required for most painful pediatric procedures.

The practitioner must assume that deep sedation or general anesthesia will occur.

The level of vigilance must be maximal in all cases!

The venue in which a patient is sedated must be fully equipped to rescue patients who may experience difficulties.

This includes both monitors and personnel!

Note: Intubated patients in the ICU do NOT fall under the moderate sedation policy.

So, how do we do this safely??

Safety doesn’t happen by accident….

…it’s achieved through prevention, planning and vigilant preparation!

2005 2006 2007 2008 2009

Patients (#) 848 759 416 751 713

Procedures (#) 848 892 271 953 1149

Failures (%) 0.5 1 2.5 2.1 1.9

When adverse events from 1969 to 1996 were compared between hospital vs. non-hospital venues, despite being healthier, the patients in the outpatient (non-hospital) settings had worse outcomes.

Cote CJ, Notterman DA, Karl HW, Weinber JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000;105:805-814.

The hospital group out-performed the non-hospital group, likely because of more expertise and higher standards. The majority of the 2nd events for the outpatient group were cardiac.

Suggests that the 1st events might have been respiratory in etiology.

Cote CJ et al. Pediatrics. 2000;105:805-814.

Complications occur in all groups, not just the extremes of age.When we look at what went wrong, many times it was failure to recognize that the patient was in trouble (no pulse oximetry, no BMV, unavailable oxygen, etc.).

Cote CJ et al. Pediatrics. 2000;105:805-814.

Drug overdoseLack of appreciation of drug/drug interactions and drug pharmacokinetics and dynamicsPoor patient selectionLack of monitoring before, during, or after the procedure (early discharge home, drug given at home)Inadequate CPR skills – “failure to rescue”

Cote CJ et al. Pediatrics. 2000;105:805-814.

The individual performing a procedure cannotsafely sedate a patient.Electronic monitoring and vigilance aids are not a substitute for the presence of a healthcare professional who is monitoring the patient using observation, auscultation, and palpation!!Monitoring by a second individual with no responsibilities other than monitoring the patient, administering drugs, and recording what has transpired is mandatory.

Inadequate oxygenation and/or ventilation?

Open Airway:Use head tilt & jaw thrust

Consider shoulder roll for < 2yo

Provide supplemental oxygenCall for help

Signs of airway obstruction?

Insert NP or OP airway

Attempt PPV

Prepare for intubation

Apneic? Begin PPV

Consider drug-inducedrespiratory depression

Opioid-induced:Give nalaxone (Narcan)

0.01 mg/kg/dose IV, may double and repeat (max 2 mg)

Benzodiazepine-induced:Give flumazenil 0.01 mg/kg/dose IV, may double and repeat (max 1 mg)

Accomplish the procedureBehavior control and immobilityPatient safety

Second person is requiredMinimal physical discomfort and pain

Minimal psychological response to treatment and maximal potential for amnesiaA rapid return to a state of consciousness in which safe discharge is possible

First decide: Is the procedure necessary and does it require sedation to be accomplished?

Who can be a moderate sedation practitioner?

Who can be a sedation monitor and a recovery assistant for patients who received moderate sedation?

What are the different requirements?

WRNMMC-B Sedation Policy

WRNMMC-B Sedation PolicyEmphasizes that sedation equals intubation

mentality

Requires generic sedation training hospital-wide

The licensed, independent practitioner (LIP) who

performs/supervises moderate or deep sedation

must have delineated privileges to do so.

WRNMMC-B Sedation PolicyAll patients should receive the same level of

treatment, monitoring, and desired outcome

regardless of the site of care

Applicable to all pediatric patients throughout

3W, NICU, ED, PICU, PSU and America Building

Provides oversight via the Operative and Other

Invasive Procedures Committee (OOIP)

A Licensed-independent Practitioner (LIP) who may be an MD/DO/PA or PNP and must be immediately available at all times until the patient is fully recovered

At least one Nurse (RN) monitor / recovery assistant at all times:

Monitor: Responsible for administration of medication ordered by the practitioner and continuously assessing and recording the patient’s physiologic and psychological status

Recovery: Assists in the recovery of the patient in the appropriately designated recovery area

Specific supplemental privileges in moderate sedation as approved by the Department Chief.Our request for maintaining competency:

This pediatric moderate sedation course and online post-test annuallyMaintain current BLS & appropriate ALS (NRP, PALS and/or ACLS) certificationAnnual competencies require demonstration of a

minimum of 5 cases per year OR the successful completion of a practical examination

**Training for DSA will require critical care or anesthesia training

Beyond 01Jan2012, all nursing staff will need to have completed the following:

Active BLS & appropriate ALS (NRP, PALS and/or ACLS).

Initial competency training and the completion of 5 sedations with direct supervision.

Command online moderate sedation training course/exam.

Annual competencies require demonstration of a minimum of 24 cases per year (may be completed in alternate settings such as the PSU). If numbers are insufficient remediation with the Command online training / exam is required.

The Department of Pediatrics is also requiring annual completion of the Pediatric Sedation Training and online post-test .

Location where MSA can be performed with pediatrics:

Only PSU, PICU, NICU and PHO

Residents:Can participate in moderate sedation activities with appropriate oversight and supervision

Cannot be the LIP. There must be a credentialed provider immediately available at all times.

CommunicationMaximize patient safetyContinuous quality improvementResearchMedicolegal documentation“Reimbursement”

Brand new Essentris notes for the Pediatric

Sedation unit available under PEDS and PICU

environments:PSU Pre-sedation Screen

PSU Nursing Sedation Record

PSU Sedation Provider Note

PSU Post-procedure Instructions

General: Pediatric weight based emergency drug sheet

Nursing: Complete PSU Nursing Record (if outpatient) or

WR PEDS/PICU Nurse Assessment JTF (if inpatient)

Flowsheet with appropriate vitals to include LOC, HR,

BP, RR, SpO2 and ETCO2 every 5 min

Post-procedure complete a Nursing Clinical Note or

Progress Note

Provider: Essentris-based sedation orders Signed Informed Consent Essentris pre-sedation H+P (top of PSU Provider Note)

Acute illness screenAirway evaluationASA classificationLabs, if appropriate (hCG?)Updated H&P within 24h of procedure / day of sedation

Immediate pre-procedure assessment (bottom of PSU Provider Note)

NPO status Universal protocol / time-out

Post-sedation procedure/assessment note (bottom of PSU Provider Note)

Review potential benefitsReview potential risks

Medication side-effects (nausea, vomiting, etc.)Failure of sedationAspirationRespiratory arrest

Review alternativesSeparate consent for must also be obtained for sedated procedure.

Prior to signature / activation,

the comment box must indicate

appropriate weight-based

and all highlighted

areas must b modified.

New and improved…

The pre-sedation assessment is used to:Identify the appropriateness of the patient for the procedure and the sedation technique.

Identify pre-existing factors that may alter drug dosage or may increase the risk of aspiration, including:

Patients with severe underlying medical conditions such as pulmonary, cardiac, neurologic, or airway malformations

Identify if the patient is an appropriate candidate for proposed sedation.Select and plan sedation care.

Medical conditions:CardiacPulmonaryRenalHepaticEndocrineSleep apneaPregnancy

Any other pre-existing factors that may alter drug dosage?

Adverse reactions to anesthesia, sedation, or failed sedationMedications taken within last 48 hoursRelevant family historyAllergiesTobacco, alcohol, drug abuseClaustrophobiaExposure to infectious diseases and need for isolation

Are increased in:Extremes of age < 2 months, > 70+ yearsPreemie graduates < 60 post-conceptual weeks of ageHistory of apnea or chronic lung diseaseIncreased intracranial pressureRenal or liver diseaseNeuromuscular disease (weakness, myotonias, muscular dystrophies, etc.)Polypharmacy

Independent risk factors for adverse respiratory events (during URI) include:

Copious secretions, history of prematurity (<37wks), nasal congestion, history of RADRespiratory events doubled from baseline during radiologic procedures

New policy: If active URI within last 4 weeks, reschedule elective sedationsWhen in doubt cancel or consult Critical Care / Anesthesia before you sedate!

Tait, Anes, 2001

The key allergies are latex, contrast dyes, and specific medications that may require change of the sedation plan.

Airway examination from nares to diaphragm:Assess the ability to open mouth & extend the headMallampati classification

Heart and lungsECG (if indicated)PregnancyASA physical status

** The higher the Mallampati score, the more potential of difficulty that may be encountered in the event of the need to intubate and

the greater the risk of a lost airway.

HabitusExcessive facial hairReceding chinSignificant obesity…or other factors that may impede successful BVM ventilation if needed.

Head and NeckShort neckLimited neck extensionDysmorphic featuresDecreased hyoid mental distance (< 3 cm adult)Neck massCervical diseaseTracheal deviation

MouthSmall opening ( < 3 cm in adults)Edentulous adultsMacroglossiaLoose teethDental appliancesNon-visible uvula

JawMicrognathiaRetrognathiaTrismusSignificant malocclusion

Always ask yourself: Are there any reasons

this patient might not be able to be bag-mask

ventilated or, if needed, intubated?

Frontal / profile assessmentJaw mobilityThyromental distanceFlexion and extension of neck

ASA Physical Status Classification System

ASA Class

Description Sedation Suitability

I Healthy, no underlying organic disease Excellent

II Mild or moderate systemic disease that does not interfere with daily routines (e.g. well-controlledasthma / diabetes / hypertension)

Generally good

III Organic disease with definite functional impairment (e.g. severe steroid-dependent asthma, chronic renal failure, poorly controlled hypertension, CHF)

Intermediate to poor; consider benefits relative to risks

IV Severe disease that is life-threatening (e.g. head trauma with increased intracranial pressure)

Poor; benefits rarely outweigh risks

V Moribund patient, not expected to survive Poor; benefits rarely outweigh risks

Patients with significant comorbid conditions or sleep apnea (ASA 3 or above)Children with neuromuscular disease affecting respiratory or brain stem function

E.g. CP with abnormal swallowingInfants < 60 post-conceptual weeks who are not residing in an ICU settingAnticipated difficulty in obtaining IV access

Patients with known respiratory or hemodynamic instabilityPatients with a history of airway problems during sedation or anesthesiaPatients who fail airway screening examination

E.g. Neck instability (Trisomy 21)Patients who may present difficulty ventilating

Pulmonary aspiration of gastric contents can be catastrophic. Normally, our airway protective reflexes prevent aspiration from occurring.Moderate to deep sedation may block these protective reflexes.In theory, pulmonary aspiration is not a problem with moderate sedation.In reality, pulmonary aspiration is always an issue because moderate sedation can become deep sedation rapidly and unpredictably.

PregnancyAcute abdominal pathology

PeritonitisBowel obstruction

GE refluxHiatal herniaMorbid obesity

Esophageal dysmotilityPrevious esophageal surgery (TE fistula)DiabetesUndocumented fasting periodIncreased intracranial pressure (ICP)Multiple trauma

These conditions may be associated with a “full stomach” or an exaggerated risk of pulmonary aspiration.

Clear liquids: 2 hoursBreast milk: 4 hoursFormula / non-clear liquids: 6 hoursSolid foods: 8 hours

The goal is reduce the amount of solids, semi-digested food, and particulate matter in the

stomach.

The BEST solution is always to simply delay the procedure, if possible!Other anesthesia-only strategies include:

Limiting the level of sedationInitiate drug prophylaxis. The goal is to raise the gastric pH and reduce the gastric volume and particulate content:

Prokinetic agents [Metoclopramide (Reglan®)]Non-particulate antacids [Sodium citrate (Bicitra®)]H2 blockers [Ranitidine (Zantac®)]

…but, again, these are not routinely used or recommended if delay is feasible.

Record vital signs every 5 minutes during

sedationTime, LOC, BP, HR and rhythm, RR, adequacy of

ventilation, SpO2, ETCO2, O2 delivery /

concentration / method, pain score

Record IV catheter placement and fluid status /

administration throughout procedure

Document times and dose of all medications

given

After completion of a procedure, patients are

transported to a recovery area

During transfer of care, a basic history, the type

of procedure, the drugs used, and any problems

or concerns are discussed.

Recovery staff will assume responsibility for the

patient until discharge.

A complete set of vitals should continue to be

checked every 15 minutes during recovery.

Failure to sedate: Defined as an aborted procedure related to inadequate sedation or paradoxical reaction

Return to baseline mental statusNormal vital signsAirway reflexes intactTolerates PO liquidsVoiding not necessary

A responsible adult must accompany the patient homeInstructions must be written and understood

Contact telephone number if problem arisesPain management must be addressedHealthcare provider signatureFollow-up telephone call (24 hours) is recommended

A 12mo female presents to the ED with tachypnea, tachycardia, bilateral pleural effusions, hepatomegaly, progressive metabolic acidosis, and 40% O2 requirement. She is irritable and uncooperative during an echocardiogram. The ED staff suggests you try “conscious sedation”…

…But, rightfully, you choose not to.

Reasoning: This patient is at least an ASA III – if not ASA IV – and requires critical care or anesthesia input, preferably for them to do study.

A 2yo male with a known seizure disorder well-controlled on anti-epileptics presents for a follow-up MRI. On your screening history and physical, you note that he has had night-time cough, wheezing, and nasal congestion for 2 days.

You choose to defer the sedation, correctly.

Reasoning: Technically, he is an ASA II but he is acutely ill and a sedation exposes him to higher risk of respiratory complications.

A 4 mo presents to the ED after reportedly “falling from his mother’s arms.” There was no LOC or seizure, but she has had several bouts of emesis. She is irritable with GCS 13. A small contusion is noted over the occiput. The ED staff asks what you want to sedate with for a head CT.

You correctly suggest trying a non-sedated CT.

Reasoning: The scan is needed to evaluate for closed-head injury and rule-out increased intrancranial pressure, but sedation is not. Head CTs are quick and the risk of sedation is increased due to age and injury pattern.

Sedation is a continuum with transition zones between levels. We always need to be prepared to handle the next deeper level. The individual performing a procedure cannot also safely sedate a patient. Monitoring by a second is mandatory.The pre-sedation history and physical exam are critical safety net components in selecting appropriate sedation candidates and sedation strategies.