ORGANIZATIONWIDE POLICY - ONLINE DOCUMENT GUIDELINES FOR THE USE OF SEDATION FOR DIAGNOSTIC AND THERAPEUTIC PROCEDURES BY THE NON-ANESTHESIOLOGIST

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1 ORGNIZTIONWIDE POLICY - ONLINE DOCUMENT Policy Number PC 04 GUIDELINES FOR THE USE OF SEDTION BY THE NON-NESTHESIOLOGIST The following guidelines are designed to allow the non-anesthesiologist to provide sedation/analgesia to their patients in a variety of settings throughout the Sacred Heart Health system when sedation is necessary to tolerate unpleasant diagnostic and therapeutic procedures. Sedation and analgesia comprise a continuum of states ranging from minimal sedation (anxiolysis) through general anesthesia and benefits the patient by reducing anxiety, discomfort and pain during uncomfortable procedures. Purpose: To provide safe sedation in the Health System; To assure that patients receiving sedation will receive a comparable level of care in all areas; To establish specific monitoring and credentialing requirements for the delivery of sedation. Policy: This policy applies to all patients who require moderate to deep sedation for diagnostic and/or therapeutic procedures. It does not include patients managed for pain control, simple or pre-op anxiolysis, emergency situations (see Procedural Sedation in the ED, page 11), EEG, or sedation in ICU where full physiologic monitoring and ventilator support are in place. Moderate and deep sedation can only be administered in approved areas in the Health System. Definitions: Minimal Sedation (nxiolysis): a drug-induced state during which patients respond normally to verbal commands. lthough cognitive function and coordination may be impaired, ventilator and cardiovascular functions are unaffected. Moderate Sedation (previously referred to as Conscious Sedation): a drug-induced depression of consciousness during which patients respond purposefully to verbal commands. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Deep Sedation: a drug-induced depression of consciousness during which patients cannot be easily aroused. The ability to maintain ventilatory function may be impaired. Procedural Sedation: the technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patients to tolerate an unpleasant procedure while maintaining cardiorespiratory function (for ED use only). General nesthesia: a drug-induced loss of consciousness during which patients are not arousable. The ability to independently maintain ventilatory and cardiovascular function may be impaired requiring cardiopulmonary support. Sedation Monitor: The healthcare person, trained in the administration and monitoring of the sedated patient. The sedation monitor is responsible for monitoring the patient s sedation level and response to sedation. The monitor will not participate in the procedure being performed.

2 PC4 PGE 2 Continuum of the depth of sedation. Minimal Sedation ("nxiolysis") Moderate Sedation/nalgesia ("Conscious Sedation") Deep Sedation / nalgesia General nesthesia Responsiveness Normal response to verbal stimulation Purposeful* response to verbal or tactile stimulation Purposeful* response following repeated or painful stimulation Unarousable, even with painful stimulus irway Unaffected No intervention required Intervention may be required Intervention often required Spontaneous Ventilation Unaffected dequate May be adequate Frequently inadequate Cardiovascular Function Unaffected Usually maintained Usually maintained May be impaired *Reflex withdrawal from a painful stimulus is NOT considered a purposeful response. I. Credentialing and Training for the Non-anesthesiologist It is the responsibility of the licensed independent practitioner (LIP) to assess the patient, choose and provide the appropriate sedation for the patient and the procedure to be done, administer sedation in the proper setting, minimize complications and assure and evaluate recovery from the sedation provided. Because individuals vary in their responses to a given dose of a specific sedative and sedation is a continuum, practitioners providing sedation require the skills needed to provide airway/respiratory management and cardiovascular support. If moderate sedation is desired, the practitioner should be competent to support a patient who may proceed into deep sedation. If deep sedation is desired, the practitioner should be competent to rescue the patient who may proceed into a deeper state of general anesthesia. Physicians, dentists or other licensed independent professionals who have been appropriately credentialed as outlined below will be allowed to administer sedative agents at Sacred Heart.. Moderate Sedation: a drug-induced depression of consciousness during which patients respond purposefully. Specifically, the drugs, doses and techniques used are not likely to produce a loss of protective airway reflexes. Initial credentialing (effective for 2 years): 1. Review Self Study Guide for Physicians: Moderate/Deep Sedation and pass a post-test with a passing score of at least 80. The study guide and post test may be found on the MedStaff Website; and 2. s appropriate for the patient s age group or status, holds either TLS, CLS, NRP or PLS certification, or be Board eligible/certified in Critical Care or demonstrate basic airway management competency through a practicum examination provided by the Department of nesthesia. Please contact the Department chairman for nesthesia to arrange this practicum.

3 PC4 PGE 3 Recredentialing: 1. Review the above self study guide and pass a post-test with a passing score of at least 80;and 2. Maintenance of life support certification (as noted in b above). 3. dverse events will be reviewed by the Quality department and referred for follow up as appropriate. 4. The Chief of nesthesia, or designee, will review any adverse events and offer opportunities for improvement. B. Deep Sedation: a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. These patients may require assistance in maintaining airway patency and ventilator effort. Recognizing that sedation is a continuum and that deep sedation is only one level from general anesthesia, the LIP credentialed in deep sedation must be competent in skills involving cardiovascular support and airway management as in general anesthesia. Initial certification (effective for 2 years): 1. Privileges in anesthesiology or critical care or emergency medicine or pulmonary medicine; and 2. Review Self Study Guide for Physicians: Moderate/Deep Sedation and complete a test with a passing score of at least 80; and 3. s appropriate for the patient s age group or status, hold either TLS, CLS, NRP or PLS certification. Recertification: 1. Review the above self study guide and pass a post-test with a passing score of at least 80; and 2. Maintain Privileges in anesthesiology or critical care or emergency medicine or pulmonary medicine;and 3. Maintenance of life support certification (as noted in c above), 4. dverse events will be reviewed by the Quality department and referred for follow up as appropriate. 5. The Chief of nesthesia, or designee, will review any adverse events and offer opportunities for improvement.

4 PC4 PGE 4 II. Training of the Sedation Monitor:. registered nurse may administer medications to achieve moderate sedation during therapeutic and/or diagnostic procedures, provided the registered nurse has completed the education and competency requirements. The registered nurse may manage patients who are receiving or recovering from moderate sedation, when a physician, dentist or other licensed healthcare professional is credentialed to administer agents given for sedation is readily available. Components of the registered nurse annual training will include: The registered nurse must have successfully completed education or training in moderate sedation. The content of that education or training must, at a minimum, include instruction on the definitions, education and competency requirements and scope of practice, including the continuum of levels of sedation and on drugs used during conscious sedation, including reversal agents, their actions, side-effects and untoward effects, and any manufacturer package inserts, and assessment and monitoring of the patient receiving the medication. The education or training must also include instruction on recognition of emergency situations, institution of appropriate nursing interventions; and evaluation of physiologic measurements, such as respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm, and the patient s level of consciousness. n educational or training program developed by Sacred Heart Health System or an approved continuing education provider that meets these requirements may be used to demonstrate appropriate competency. Certification in CLS and/or PLS is required. B. When the procedure requires the use of deep sedation and the patient is not intubated, the proceduralist will require the assistance of another physician credentialed in deep sedation. In this situation, the proceduralist does not need to be credentialed in sedation, but the sedation monitor must be a physician credentialed in deep sedation (as outlined above). The sedation monitor will not participate in performance of the procedure but focus on the patient s airway management and medication administration. C. When the procedure requires the use of deep sedation and the patient is intubated, a single physician with deep sedation privileges may be the proceduralist and oversee the administration of sedation. Locations: Sedation may be administered in the following locations: Location SHHS-P* SHHS-EC* OR/PCU X X Surgery Center X Critical Care Units X X Intensive Care Nursery X Progressive Care Unit X X Endoscopy Services X X Radiology, including CT and MRI X X Radiology ngiography X Non-invasive cardiology. (Heart and Vascular Institute) X Cardiac Catheterization X X EPS Laboratories X Emergency Department X X SHHS-P* = Sacred Heart Health System Pensacola SHHS-EC* = Sacred Heart Health System Emerald Coast

5 PC4 PGE 5 III. Pre-Procedure ssessment and Documentation: Physician Procedure Record (FFM ) ssessment must include: Identification of the patient, with patient ID wristband applied, llergies Height & weight (in kg) Plan for sedation Review of health history and assignment of S Class irway assessment with Mallimpati Score and history of failed sedation or anesthesia. Discussion of the risks and benefits of the procedure and the sedation to be used. Consent signed. Data may be collected by an RN, LPN or RRT (Bronchoscopy) but must be reviewed and signed by the physician providing sedation. The physician will decide if the patient is a suitable candidate for the planned sedation and assign the appropriate S score. S Medical Description of Patient Comments Classification S I No known systemic disease May have sedation S II Mild or well controlled systemic disease without other consultation. S III Multiple or moderate controlled systemic disease(s) Consider nesthesia consult SIV Poorly controlled systemic disease(s) Mandatory involvement S V Moribund patient is not expected to survive without intervention of nesthesiology irway ssessment: Particular attention should be paid to conditions associated with complex airway management, potential for aspiration, the rapid onset of hypoxemia, and/or a history of difficult sedation. Because unfavorable airway anatomy may make rescue from unexpected deep levels of sedation much more difficult, before each procedure an evaluation of the airway should be made including: determination of the patient s Mallampati score (on the right). n evaluation of the mobility of the cervical spine Extent of mouth opening should be made. If unfavorable airway conditions are found - Mallimpatti score of 3 or greater, mouth opening less than three finger breadths, or the inability to extend the neck one should consider anesthesia consultation. One should seek history of difficult or failed intubation, obstructive sleep apnea (OS), TMJ problems, or airway surgery. Frequently, history of OSlike symptoms is best obtained from others; not the patient. Obesity increases risk. Because of concurrence with both OS and dependent hypoxemia, patients with BMI > 35 are at high risk for airway management issues and accelerated onset of hypoxemia. history of reflux requiring treatment or aspiration may require prophylaxis and/or anesthesia consultation.

6 PC4 PGE 6 history of failed sedations or opioid-based chronic pain management may require much larger than the usual doses of medication with the potential for complex procedural interactions and the need for extended post procedural observation. nesthesia consultation is appropriate when one has a high index of suspicion for the above conditions or any other related concern. ssessment of the Pediatric Patient: The presence of an anesthesiologist should be considered for the pediatric patient with any of following conditions: History of ongoing apnea or history of prematurity with post-conceptual age < 60 weeks. Full-term infant less than 1 month of age. Patients with current respiratory compromise. Craniofacial abnormality with associated abnormal airway that may make it difficult to establish effective mask ventilation. Uncontrolled/unpredictable gastroesophageal reflux or vomiting that poses a risk for aspiration. Cyanotic cardiac disease or unstable cardiac status, e.g., cardiomyopathy. ny high-risk procedure that may require the presence of an anesthesiologist to assist with resuscitation. procedure that requires pauses in respirations (breath holding) on a child who will be unable to follow command. procedure performed in a remote location that would result in an excessive delay of arrival of emergency help. Inadequate qualified personnel available to provide safe sedation. IV. Monitoring Requirements. The monitoring below is required for all patients receiving sedation/anesthesia as defined by this policy:. During the course of a procedure, at least two (2) qualified individuals must be present at all times: (1) the proceduralist and (2) the sedation monitor. When moderate sedation is the plan, the proceduralist must be credentialed in moderate sedation and the sedation monitor may be an RN trained in moderate sedation. The RN must monitor the patient s response to sedation and any untoward response be communicated to the proceduralist immediately. The RN/sedation monitor will not assist with the procedure. If assistance with the procedure is needed, other medical personnel should be called upon to assist. When deep sedation is the plan, the sedation monitor must be a physician credentialed in deep sedation. This person should be ready to rescue the patient if the airway is compromised. B. Continuous measurement of oxygen saturation and pulse rate. dminister Oxygen by mask or nasal cannula, as indicated to maintain normal oxygen saturation rates, and as ordered by the physician. Physician orders for oxygen should be documented on the physician s order sheet. C. Blood pressure, pulse, respirations, and oxygen saturation will be recorded a minimum of every five (5) minutes until the procedure is completed and the patient is ready to be recovered. D. Continuous cardiac monitoring. Observe the cardiac monitor continuously and document the rate and any abnormal rhythm changes at least every five (5) minutes or more often as appropriate during the procedure. Monitoring is the combined responsibility of the nurse and physician. When arrhythmias are noted, they are communicated to all members of the patient care team and appropriate interventions are taken. For pediatric patients, see page 9 of this policy. E. Close visual observation in a room adequate to facilitate assessment of the patient's color and respiratory status. F. IV line or reseal that is confirmed patent prior to sedation.

7 PC4 PGE 7 For pediatric patients see page 9 of this policy. G. Equipment - The following equipment must be checked prior to start and immediately available during administration and subsequent monitoring of sedation/anesthesia: o Cardiac Monitor o Blood pressure monitoring device. o Pulse oximeter. o Capnography o Bag-valve-mask device (ambu). o O2 flow meter. o Oral airway. o Suction equipment. o Code 3 Cart (s/b Code Blue Cart). o Reversal agents naloxone (Narcan) and flumazenil (Romazicon). o IV Pump to administer IV fluids, IV medications, blood, and/or blood components as needed. H. During the Procedure: Baseline vital signs must be performed and documented no more than 5 minutes before start of sedation: BP, Pulse, RR and 02 sat will be recorded every 5 minutes or more often if appropriate during the procedure. The patient will have continuous cardiac monitoring and O2 sat monitoring throughout the procedure. For pediatric patient monitoring, see Section VI, page 10 of this policy. Resuscitation equipment must be immediately available to the procedure room where the procedure is conducted. During monitoring, any change in the patient s physiological status (increased/decreased blood pressure, decreased oxygen saturation, etc.) should be communicated to the attending physician immediately, and appropriate interventions and patient response documented. Immediate intervention is required for any of the following signs and/or symptoms: o Respiratory rate less than 10, shallow respirations, airway obstruction, apnea, o O2 saturation less than 90% by pulse oximeter (unless the patient has a pre- existing condition with a baseline O2 saturation less than 90%, in which case intervention is required, if there is a sustained decrease in O2 saturation more than 5% below the patient's baseline). o CO2 monitoring through capnography: the actual number is not need, but confirmation of breathing is required. Document + to confirm waveform and - if no waveform. If no waveform, patient is apneic and immediate response (stimulation, repositioning, intervention) is necessary. o o o Hypotension/hypertension: 20% less than or more than pre-procedure. Hypothermia. (Due to the inability for elderly patients and children to selfregulate their body temperature, core body temperature should be monitored immediately after the procedure.) Possible interventions include (This is not intended to be an all-inclusive listing of interventions or necessarily the sequence in which interventions should occur.) 1. General stimulation. 2. Opening and maintaining airway including jaw thrust. 3. Supplemental O2 by cannula or mask. 4. Inserting oral airway in an unconscious patient without an intact gag reflex. 5. Giving IV fluids or other agents to maintain blood pressure. 6. ssisting ventilation with a bag-valve-mask device (ambubag). 7. Intubation.

8 PC4 PGE 8 8. dministration of narcotic antagonist (naloxone/narcan) or benzodiazepine antagonist (flumazenil /Romazicon). Note: repeat doses of narcotic antagonist may be required depending upon the amount, type and time interval since last administration of narcotic. 9. Initiating Code Team response. n RN may perform the above interventions independently with the exception of intubation and administration of sedation reversal or drug agents to maintain BP. The physician should be notified STT if these interventions are required. The physician is to be notified immediately regarding adverse effects after sedation and any emergency interventions used to stabilize the patient. physician s order must be documented for all interventions except for general stimulation and/or opening and maintaining airway. Patient s response to interventions should also be documented. Special Note: When emergency assistance is needed during a Moderate Sedation procedure, the nurse shall immediately notify the attending physician and supervisor, and appropriate assistance will be summoned (i.e., Emergency Department physician, Hospitalist). I. Recovery Following Moderate/Deep Sedation. o ll patients who have been sedated for procedures will be recovered using: Continuous monitoring (ECG, B/P, Temperature, oximetry) with assessment and documentation every 15 minutes. o n RN must make the initial assessment during the recovery phase, and the final assessment rior to discharge. o If complications arise, the nurse will notify the physician who performed the procedure immediately. V. Discharge Criteria and Procedures.. Patients should not be discharged until they are alert (may be sleepy, but easily arousable), oriented (or return to baseline mentation) and with stable vital signs (which are within the pre-procedure range). Vital signs must remain stable for two f ifteen-minute consecutive intervals (three consecutive BP readings). Continuous cardiac and O2 sat monitoring must be continued throughout the recovery phase. B. The discharge summary checklist should be completed on the Sedation Procedure record. Note: To ensure that patients do not become re-sedated after effects of a reversal agent have abated, sufficient time (not less than two hours) must elapse from last administration of reversal agents [naloxone (Narcan) or flumazenil (Romazecon)]. C. ldrete Scoring is used to evaluate the patient s readiness for discharge. Most patients will be discharged from recovery with a score of 8, 9 or 10. Chronically debilitated, senile or paralyzed patients may never receive scores these scores. These patients must be treated individually and discharged at the discretion of the physician.

9 PC4 PGE 9 LDRETE SCORE: Respiration Coughs and deep breathes Regular, quiet, adequate Obstructed, noisy, inadequate Circulation/BP Within 20% of pre-op Within 20-50% of pre-op Within 50% of pre-op Skin Normal color, dry Flushed, pale, sweaty Dusky, cyanotic LOC lert, oriented rousal by voice Non-responsive ctivity Purposeful movement of all extremities Non-purposeful Not moving extremities ldrete Scoring Guidelines are not intended for use in the Neonatal Intensive Care Unit where assessment and monitoring during recovery is specific to this unit's patient population. D. Discharge from recovery shall be the responsibility of the physician, or his designee (i.e., covering physician), and does require a written discharge order. E. INPTIENTS: The patient unit which the patient will be returning to will be notified of time of patient's return and of any needed equipment. fter transferring the patient to room, raise side rails and fasten call button within reach, and give report to nurse accepting patient. F. OUTPTIENTS: Will be discharged to the care of a responsible adult after receiving the following: o o o Written discharge instructions. Instructions of adverse symptoms to report following discharge. Instructions on who to notify should a problem arise following discharge. (i.e., covering physician), and does require a written discharge order. VI. Pediatric Sedation. The pediatric patient has special considerations and needs during sedation. The indications may be different as the developmental level of learning and understanding vary by age and developmental achievement. Non-invasive procedures such as MRI, CT Scan and Nuclear Medicine may require moderate sedation to help children relax and be able to undergo testing that requires them to be still for periods of time. dditionally, emotional and developmental delays place an added burden on the child to understand and cooperate. Pediatric sedation for painful procedures may require deep sedation. The pediatric patient s physiological responses are different. Blood pressure changes are a late sign of change in the pediatric patient. Oxygen saturation, heart rate, respiratory rate, skin color, and temperature are the best indicators of change. The following guidelines are in place for the pediatric patient: Vital Signs o Blood pressure should be attempted minimally before and after the procedure. It may not be possible to obtain accurate blood pressure due to movement or the inflation of the auto cuff waking the child.

10 PC4 PGE 10 o O 2 saturation, heart rate, respiratory rate are recorded minimally every 5 minutes. o Skin color and temperature are recorded pre-procedure and any changes recorded. Temperature is a concern in infants as cold rooms and equipment can lower temperature quickly and affect respiratory status. o IV ccess is not required for oral sedation in non-invasive procedures with the exception of Chloral Hydrate medication when the child is known to have increased intra-cranial pressure. o Cardiac Monitoring. o Placement of leads may agitate the frightened child and interfere with certain tests. o Continuous cardiac monitoring should be performed if history reveals any known rhythm disturbance secondary to pre-existing medical conditions. NPO Status: Ingested Material Clear Liquids Breast Milk Infant Formula Non-human milk Light meal (e.g. dry toast, clear liquids) Minimum Fasting Period 2 hours 4 hours 6 hours 6 hours 6 hours Children at risk for regurgitation or aspiration, (e.g., known gastro-esophageal reflex, extreme obesity) may benefit from pharmacologic therapy to reduce gastric volume and increase gastric ph before sedation or from a longer NPO period of time prior to the procedure. If delayed gastric emptying is present, one should consider nesthesiology or GI consult before sedation/analgesia. VII. Dosing Recommendations for dult and Pediatric Patients.. Medications: 1. Many medications, alone or in combination, are used successfully in moderate sedation and analgesia. Individualization and titration of the medications are important determinates of successful moderate sedation (conscious sedation). 2. Individualization and titration of the medications are important determinants of successful sedation. 3. In general, after the initial dose of a medication is given, additional doses should not be given until the effect of the first dose can be determined. 4. t the completion of the procedure, the duration of action of the drugs used should be considered in the recovery and discharge process. 5. Initial doses of sedation medications should be adjusted based on the number of f actors including the patient s age, co-morbidities, and physical status. B. Information on commonly used sedation medications is provided in the Pharmacology of Moderate Sedation Medications table (ppendix ) provided in this policy. The information included here should not take the place of a physician s judgment. C. Experience is an important determinate of success in sedation: 1. Physicians who perform ten or less procedures a year using moderate sedation may find it prudent to limit their drug choice to midazolam given in an initial dose of 0.5 to 2 mg over two minutes with additional doses titrated for effect after the peak effects of the previous dose has passed. 2. Physicians more experienced in moderate sedation may add a second IV drug, again titrated carefully for effect after the peak effects of the previous drug(s) has passed. D. In general IV drugs given are preferable for moderate sedation, unless vascular access Is difficult or impractical. 1. Other routes of administration require care consistent with IV sedation including recovery. 2. Variable absorption rates of oral, nasal, and rectal medications compounded by the patient s diagnosis and co-morbidities require extra care, skill, and experience by the physician ordering the sedative medication by these routes.

11 PC4 PGE 11 VIII. Procedural Sedation in the ED The Emergency Department (ED) is a unique environment where patients present on an unscheduled basis with often complex problems that may require several emergent or urgent interventions to proceed simultaneously to prevent further morbidity or mortality. Emergency medicine-trained physicians have a specific skill set to manage airways and ventilation that is necessary to provide patient rescue. Therefore, these practitioners are uniquely qualified to provide all levels of analgesia/sedation an anesthesia (moderate to deep to general) (1). The appropriate management of pain and anxiety in the ED is a significant facet of emergency care for patients. Procedural sedation is defined as the technique of administering sedatives or dissociative agents with or without analgesics to induce a state that allows the patient to tolerate unpleasant procedures while maintaining cardiopulmonary function. The terms moderate, deep, and general anesthesia sedation refer to forms of sedation that do not apply to dissociative sedation. Dissociative sedation is described as a trancelike cataleptic state characterized by profound analgesia and amnesia with retention of protective airway reflexes, spontaneous respirations, and cardiopulmonary stability. (2) Because individuals vary in their responses to a given dose of a specific sedative, practitioners providing procedural sedation and analgesia require the skills need to provide airway/respiratory management and cardiovascular support. (1) Thus, the licensed practitioner providing procedural sedation must be acutely aware of the patient s cardiopulmonary status and proficient in the skills needed to rescue a patient who would experience cardiopulmonary compromise.. Before the Procedure: 1. Obtain a history and perform a physical examination to identify medical illnesses, medications, allergies, and anatomic features that may affect procedural sedation, analgesia and airway management; document in the emergency room record. 2. No study has determined a necessary fasting period before initiation of procedural sedation and analgesia. The combination of vomiting and loss of airway protective reflexes is a rare occurrence. lthough recent food intake is not a contraindication for administering procedural sedation and analgesia, the emergency physician must weigh the risk of pulmonary aspiration and the benefits of providing the sedation based on the individual needs of the patient. 3. Supportive equipment for procedural sedation and analgesia includes oxygen, suction, medications, and advanced life support equipment. This is the same equipment for any level of sedation (see page 7 of this policy). B. During the procedure: 1. Monitoring the patient s condition involves visual observation and assessment of the level of consciousness and physiologic changes. Monitoring includes the level of consciousness, respiratory rate, oxygen saturation, heart rate, blood pressure and cardiac rhythm monitoring. This data will be assessed and documented just prior to initiation of sedation and every 5 minutes during the procedure; document in the emergency room record. 2. s with any other level of sedation, procedural sedation requires the dedicated use of a sedation monitor to continuously assess the cardiopulmonary status of the patient throughout the procedure. The sedation monitor will not participate in the performance of the procedure, itself, but will solely monitor the cardiopulmonary status of the patient and immediately notify the proceduralist of any change in the patients status. For those sedative agents identified as for moderate sedation, (see ppendix : Pharmacology of Sedation Medications) the RN trained in moderate sedation may perform as the sedation monitor. For those sedative agents identified as B for Deep Sedation only, the sedation monitor must be an nesthesiologist or a physician credentialed in Deep Sedation. For those sedation agents identified as C for moderate or deep, the physician will determine the cardiopulmonary risk based on the patients status and the medication

12 PC4 PGE 12 Note: used. For a generally healthy patient with low risk for cardiopulmonary compromise, a RN may participate as the sedation monitor. For the patient with multiple co-morbidities, several systemic disease processes, and high risk for cardiopulmonary compromise, the sedation monitor must be an nesthesiologist or a physician credentialed in Deep Sedation. The Board of Nursing in the State of Florida only recognizes the administration of moderate sedation within the scope of practice for the Registered Nurse. dministration of medications deemed to be Deep Sedation medications must be administered and monitored by the physician credentialed in deep sedation. C. Post Procedure: 1. The patient will continue to be monitored every fifteen (15) minutes for one hour until the effect of sedation has subsided and the patient has been determined to have returned to baseline. Patients receiving deep sedation and/or dissociative agent may be arousable but return to sedated state readily. They should be monitored until they can remember the previous discussion. 2. The patient will be assessed using ldrete Scoring to evaluate for discharge (page 9). ny adverse reactions will be reported to the sedation practitioner immediately. 3. Patients must meet the same discharge criteria as outlined on page 9 of this policy. discharge order will be written by the physician and must include: Instructions on adverse symptoms to report and who to notify should a problem arise after discharge. If the patient is being discharged home, a responsible adult should receive the above instructions and assure transportation for the patient. Performance Expectations in Moderate Sedation. t a minimum, the following expectations will be used in the performance improvement process: 1. Preprocedural assessment is completed before the procedure 2. The airway is evaluated 3. The presence/absence of OS is documented 4. Needed staff is present 5. Needed equipment is present 6. Needed monitoring is done 7. Vital signs are documented according to policy 8. ppropriate recovery is provided 9. Discharge obligations are met 10. ppropriate drugs are used; in appropriate doses & titrated for effect B.Events to be reviewed 1. Oxygen saturation of <90% for > 5 minutes 2. ny oxygen saturation of <80% 3. Use of reversal medications 4. Cardiac or respiratory arrest 5. dmission to a higher level of care 6. Death

13 PC4 PGE 13 References: 1. Windle, Mary L. PharmD ; Kullarni, Rick, MD; procedural sedation; emedicine.medscape.com/article/109695; Updated pr 29, The merican College of Emergency Physicians Clinical Policies Subcommittee on Procedural Sedation and nalgesia; Clinical policy:procedural sedation and analgesia in the emergency department; nnals of Emergency Medicine; February 2005; pg merican Society of nesthesiologists Task Force on Sedation and nalgesia by Non- nesthesiologists; Practice guidelines for sedation and analgesia by non-anesthesiologists; nesthesiology,v 96, No4, pr 2002; 0g EMSC Panel on Critical Issues in the Sedation of Pediatric Patients in the Emergency Department; clinical policy:critical issues in the sedation of pediatric patients in the emergency department; nnals of Emergency Medicine, V51, No4, pr 2008, page Origination Date: 09/1993 Originating Dept: Quality/Risk Mgmt Director/VP: Steve dams, Director Revised By: Steve dams Date: 03/1996 Revised By: D. Foshee, Dir Date: 07/1999 Revised By: S. dams Date: 11/2001 Revised By: M. Darden Date: 09/2002 Revised By: M. Darden Date: 07/2005 Revised By: S. dams Date: 12/2006 Revised By: S. dams Date: 07/2007 Revised By: S. dams Date: 01/2008 Revised By: M. Brown, MD, VPM/CMO Date: 06/2010 Revised By: D. May, RN, Date: 02/2011 Revised by: D.May, RN Date 02/2012

14 PC4 PGE 14 ppendix : Pharmacology of Sedation Medications gent Med Use Onset Peak Duration ntagonist Half-Life Usual Dose* Notes Benzodiazepines Midazolam IV:1-5 IV: 2 IV: Flumazenil (Versed) IM: 5-15 IM: IM: 1-6hrs (Romazicon) Intranasal: <5min PO: 30 Intranasal: 10 PO: 2-6 hrs Diazepam (Valium) Lorazepam (tivan) IV:1-5 PO: IV: 5-20 IM: IV: 10 IV: Flumazenil (Romazicon) Up to 2 hrs 6-8 hrs Flumazenil (Romazicon) 1-4 hrs 0.5 mg over 2 min MR ½ dose q5. Do not exceed 2.5 mg as initial dose or 1.5 mg initially in elderly, Max 5 mg IV/PO: mg/kg IM mg/kg Nasal: mg/kg (not an approved route) hrs 2-10 mg, Max 20 mg IV: mg/kg/dose PO: mg/kg/day (Max 10 mg) hrs 0.05mg/kg; Max 2mg IV, 4 mg IM mg/kg Give slowly. MR q 5 min w/ 0.5mg; can be given by infusion. dolescent/pediatric patients may exhibit paradoxic excitement. Decrease dose by 30% (50% in the elderly) if patient is taking other narcotics or CNS depressants. MR 5-10 min intervals w/ 1 mg. Increased half-life in neonates, elderly. MR 5-10 min intervals for prolonged sedation used in critical care setting. Opioids (Narcotics) Fentanyl (Sublimaze) IV:1-3 IM: 7-8 TM: 5-15 Morphine IV: 5-10 IM: PO: Remifentanil (Ultiva) Sedative Hypnotics Propofol (Diprivan) IV: 5-15 IM: TM: IV: IM: PO: 1-2 hrs. IV: IM: 1-2 hrs TM: 12 hrs IV: 1-4 hrs IM: 4-5 hrs. PO: 1-2 hrs. B IV: min Dose dependent, 5-15 after discontinuing drug B IV: secs Naloxone (Narcan) Naloxone (Narcan) 2-4 hrs (longer with TM route) mcg IV IV/IM: mcg/kg/dose. TM: 5-20 mcg/kg. 2-4 hrs 2,5-10 mg IV slowly Pediatric does: IV: mg/kg IM: mg/kg Naloxone 10-20min 1 mcg/kg over sec 1 min 3-10 min None 4-7 hrs Initial: 2-2.5mg/kg Maintenance: mcg/kg/min Initial: mg/kg Maintenance: mcg/kg/min MR 25 mcg q 5. Give slowly to prevent chest wall rigidity. pnea may occur. MR 2-5 mg q5. Give slowly. ssess patient s pain level, hypotension, nausea & vomiting. Be mindful of chest rigidity; paralytic will relax. ssess patient s pain after procedure secondary to short length of action. May cause hypotension, bradycardia, or respiratory depression.

15 PC4 PGE 15 Etomidate (midate) Chloral Hydrate Dissociatives Ketamine (Ketalar) Barbiturates Methohexital (Brevital) Pentobarbital (Nembutal) ntagonists Naloxone (Narcan) Flumazicon (Romazicon) C secs 1 min 3-5 min None 2-3 hrs Initial: mg/kg over secs Maintenance: 5-20 mcg/kg/min min hrs None 8-11 hrs (longer in neonates) C IV: secs IM: 3-4 B C IV: 30 sec Rectal: 5-15 IV: 1 min IM: IV: 1-2 IM: 2-5 IV: 1 min IM/Rectal: IV: 45 secs Rectal: 5-10 IV, IM: IV: 5-10 IM: IV: Rectal: mg, Max 2g/day mg/kg/dose None IV: mg/kg IM/Rectal: 3-8 mg/kg PO: 5-6 mg/kg IV: 1-2 mg/kg/dose PO: 6-10mg/kg IM: 4-5 mg/kg/dose Rectal: 5-10 mg/kg None 6-8 hrs Initial: mg Maintenance: mg every 4-7 IM: mg/kg of 5% solution Rectal: 25 mg-kg of a 1% solution. IV: variable None hrs IM: mg IV: 2mg/kg N/ (3-4 hrs neonates) mg IV. May titrate for reversal (add 0.4mg in 10 ml syringe; give 1ml=0.04mg) mg/kg hr. N/ mg IV over 15 sec, Max 3 mg/hr. MR q1min to max 1 mg mg/kg over 15 sec. MR q1min to max 2 mg. Solution may cause pain on injections. Preadministration of lidocaine may be considered. Induces sleep 1-4 hrs. Monitor airway, O2 saturations. Sedation failure increases with age. Best used in children younger than 3 years of age. May cause emergence reactions, including vivid dreams, hallucinations, or delirium. May cause paradoxical excitement in children & elderly IV no faster than 50 mg/min. llow does for effect. Monitor for prolonged recovery. MR q 1 min to max of 10 mg. observe for resedation. May not reverse CV effects. May cause noncardiogenic pulmonary edema. Observe for resedation. Use with caution in patients with a history of benzodiazepine abuse or seizures. *Usual dose is a safe dose to begin sedation. Higher doses are frequently administered. The practitioner must be aware that the higher the dose, the greater the risk of complications. MR= may repeat TM= transmucosal Pediatric dose is for children >6 months of age. = Used in moderate sedation B= Used in deep sedation only C= Used in both moderate and deep sedation/procedural sedation in ED