CENTRAL IOWA HEALTHCARE Marshalltown, Iowa

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1 CENTRAL IOWA HEALTHCARE Marshalltown, Iowa CARE OF PATIENT POLICY & PROCEDURES Policy Number: 4.44 Subject: Purpose: Policy: Procedural Sedation (Adult/Pediatric) To establish appropriate standards for administering and monitoring sedation in the adult and pediatric patient. Procedural sedation and analgesia for diagnostic, therapeutic and invasive procedures shall be practiced throughout the hospital in accordance with these guidelines. Procedural sedation will be ordered by a physician and the patient continuously monitored by competent RN or physician. These monitoring standards may be exceeded based on the complexity of procedures and the patient s health status. Anesthesia Providers are credentialed to provide all areas of sedation, Levels 1-4. Additional Information: 1.0 Levels of Sedation A. Level 1: Analgesia and Anxiolysis: A drug induced depression of consciousness during which patients respond purposefully to verbal commands either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patient airway and spontaneous ventilation is adequate. Cardiovascular function is maintained. B. Level 2: Moderate Sedation/Analgesia (Conscious Sedation): A drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. C. Level 3: Deep Sedation/Analgesia: A drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patents may require assistance in maintaining a patient airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. D. Level 4: General Anesthesia: Consists of general anesthesia, spinal or major regional anesthesia. It does not include local anesthesia. A drug induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance maintaining a patient airway and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug induced depression of neuromuscular function. Cardiovascular function may be impaired.

2 Procedural Sedation (Adult/Pediatric), Page Levels of Sedation: Considerations Regardless of the intended level of sedation or route of administration of medications, the sedation of a patient represents a continuum and may result in the loss of a patient s protective reflexes. The intended level of sedation may not always be obtained or maintained. It will be required that the monitoring and patient care provided will reflect the recognition of this continuum and preparations be made to deliver care based on assessment of the patient. Adult: RN/Physician administering sedation/analgesia will review the patients pertinent medical history and how these might alter the patient s response to sedation/analgesia. Pediatric: Emphasis must be placed on the difference in children versus adult sedation/analgesia. Sedatives are generally administered to gain the cooperation of the child. The ability of the child to cooperate depends on chronologic and developmental age. Children in this age group are particularly vulnerable to the adverse effects of sedatives on respiratory drive, patency of airway and protective reflexes. 3.0 Monitoring Guidelines by Procedural Level of Sedation A. Level I, Minimal Sedation: Level I sedation may be administered by any practitioner with appropriate clinical privileges. At a minimum, the patient receiving level I sedation will have visual and verbal contact throughout the sedation period, be assessed for levels of consciousness. Oxygen saturation levels will also be monitored. B. Level 2, Moderate Sedation/Analgesia: Moderate sedation will be administered under the immediate direct supervision of a physician or dentist who is clinically privileged to perform moderate sedation. During moderate sedation, the ACLS/PALS RN monitoring the patient, may assist with minor, interruptible tasks once the patient s level of sedation/analgesia and vital signs have stabilized, provided that adequate monitoring for the patient s level of sedation is maintained. The ACLS/PALS RN will monitor the patient s level of consciousness, medications given, vital signs, oxygen saturations and cardiac rhythm during the procedure. C. Level 3, Deep Sedation/Analgesia: Will be administered only by a physician holding appropriate clinical privileges. A designated ACLS/PALS RN will be present to monitor the patient throughout procedures performed with Deep Sedation/Analgesia. During Deep Sedation/Analgesia the monitoring ACLS/PALS RN will have no other responsibilities, than to provide immediate patient care. The physician must be able to rescue the patient should they advance to level 4 anesthesia. D. Level 4, Anesthesia will be administered only by an anesthesiologist or a certified registered nurse anesthetist (CRNA), holding appropriate credentials and clinical privileges. 4.0 Consent for Sedation: A. The patient or the patient s parent/legal representative must be informed about the risks and benefits and must consent to the proposed sedation plan.

3 Procedural Sedation (Adult/Pediatric), Page 3 B. Documentation of consent for Procedural sedation will be included in the medical record. This may be included with the consent for the procedure. 5.0 Nursing and Physician Qualifications Special Consideration: Diprivan, IV ketamine and etomidate as used for anesthesia, deep sedation or monitored anesthesia care (MAC) will be administered only by persons trained in the administration of general anesthesia, (CRNAs or anesthesiologists) and not involved in the conduct of the surgical/diagnostic procedure. Patients receiving Diprivan, IV ketamine or etomidate will be continuously monitored for maintenance of patent airway, artificial ventilator need, O 2 enrichment. Rescue equipment must be immediately available. A. RNs and Physicians administering and monitoring sedation and analgesia will demonstrate continued competency in the following. 1. Competent in definitions and assessment of level of sedation Mallampati Score and thyromental distance (Appendix IV). 3. ASA class assessment and designation (Appendix IV) 4. Riker Scale (sedation/agitation scale). *See special guidelines for Riker Assessment Score 7 Dangerous Agitation Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side 6 Very Agitated Requiring restraint and frequent verbal reminding of limits, biting ETT 5 Agitated Anxious or physically agitated, calms to verbal instructions 4 Calm & Cooperative Calm, easily arousable, follows commands 3 Sedated Difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again 2 Very Sedated Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously 1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands *Special Guidelines for Riker Assessment a. Agitated patients are scored by their most severe degree of agitation as described. b. If patient is awake or awakens easily to voice ( awaken means responds with voice or head shaking to a question or follows commands), that s a Riker 4 (same as calm and appropriate might even be napping). c. If more stimuli such as shaking is required but patient eventually does awaken, that s Riker 3. d. If patient arouses to stronger physical stimuli (may be noxious) but never awakens to the point of responding yes/no or following commands, that s a Riker 2. e. Little or no response to noxious physical stimuli represents a Riker 1.

4 Procedural Sedation (Adult/Pediatric), Page 4 5. Airway management. 6. Medication Management 7. Vital signs management, recognition of abnormalities and required appropriate intervention. 8. Documentation requirements 9. Hands on training masking patients in the OR 10. Successful completion of written exam B. An ACLS/PALS provider will be present in the procedure. C. Patients in the ER will have their sedation levels monitored and documented using either the Riker scale or the Richmond Agitation Sedation Scale (RASS). Equipment List: Needs to be evaluated based on the patient s size, age and type of procedure being performed. Oxygen/Oxygen delivery devices Suction apparatus/catheters Noninvasive blood pressure device and blood pressure cuffs Pulse oximeter and probes Pediatric and Adult Code cart immediately available IV Equipment Pharmacologic antagonists (Naloxone or Flumazenil (Romazicon)) Procedure: Pre-Procedure A. Physician Responsibilities 1. Documentation of current medical history including allergies will be present 2. The following will be assessed and documented: a. Risk Assessment: For patients assessed to be an ASA IV and/or mallampati class IV and sedation is necessary, an anesthesia provider will be consulted and present to coordinate sedation and airway management. b. Limited neck range of motion and thyromental distance less than 3 finger breadths. Anesthesia will be consulted. c. For all patients receiving procedural sedation a Physician Pre-Sedation Assessment Form will be completed (Appendix IV). In the event that anesthesia is involved, pre-procedural assessment may be documented on the anesthesia record, and will include assessment and documentation of ASA and mallampati class. d. Informed consent the physician is responsible to explain the risks versus benefits involved in the procedure and in the use of procedural sedation and document. B. RN Responsibilities 1. The following will be assessed and documented: a. Baseline level of consciousness (Riker Scale), blood pressure, pulse O 2 saturation and respirations. A baseline rhythm strip may be ordered by the physician. b. For all patients: A physician Pre-Sedation Assessment will be completed (Appendix IV). Nurse to review and check for completion. c. Medication history and reconciliation (Reference Policy #4.80). d. For all patients, a weight will be recorded.

5 Procedural Sedation (Adult/Pediatric), Page 5 2. The RN will provide pre-procedural teaching, provide assurance and advocacy. 3. Intravenous access will be obtained per physician orders. 4. Initiate and document a time-out as indicated in the Universal Protocol. C. Intra-Procedure 1. Physician Responsibilities a. Provide treatment and medication orders to the RN or administer medications. b. Complete procedure as consented through the process of informed consent. c. Remain with the patient during the procedure. 2. RN Responsibilities a. Administer medications at appropriate doses per physician s orders (Reference Appendix I & II). b. The patient will be on continuous monitoring for EKG, blood pressure, and oxygen saturation. Patients receiving moderate sedation will have their BP, heart rate, oxygen saturation and level of consciousness documented every 15 minutes. Significant changes in any of these parameters will be reported to the physician. 1. Vital Signs 2. Level of consciousness per Riker Scale and per sedation definitions in Oxygen saturations 4. Patient tolerance of procedure 5. Medications given and response (Reference Appendix I and II). 6. Oxygen will be administered to all patients receiving sedation, levels 2-4. c. Cardiac rhythm will be assessed throughout the procedure as appropriate. Any changes will be reported to the physician, documented and treated per physician s order. d. Provide patient comfort measures. 3. Antagonistic drug and rescue equipment will be immediately available during the procedure. D. Post-Procedure 1. Physician Responsibilities a. Document procedural report b. Remain in the facility until patient is reported to be stable within 20% of baseline for vital signs and LOC. c. Provide treatment orders to the RN as required. 2. RN Responsibilities a. Assess and document patient response to procedure and medication. b. Continue to monitor vital sign and level of consciousness until discharge criteria are met. c. Provide discharge teaching and document.

6 Procedural Sedation (Adult/Pediatric), Page 6 3. Use of reverse agents will indicate an extended recovery and monitoring period. Monitor for a minimum of two hours after last dose of reversal agent. E. Discharge Criteria: 1. Following the procedure, check vitals and level of sedation every 5-15 minutes. 2. Offer fluids by mouth post-procedure, if appropriate or according to physician s orders/protocol. 3. Prior to hospital discharge, patients must be classed with a discharge criteria score on the Modified Aldrete scale of 13 (criteria approved by the Medical Staff). The physician is notified if discharge criteria of 13 are not met or if discharge criteria are met and the RN does not feel the patient should be dismissed to go home. 4. Patients will meet discharge criteria as defined in Policy 4.86 Outpatient Post Sedation Anesthesia/Analgesia Discharge Criteria and Procedure. Originated by: Care Of Patient Effective date: July 1992 Authorized by: OR Cmte 10/16 Exec. Cmte 8/16 Director of Anesthesia Date Authorized by: Chief Nursing Officer Date Revision date: 8/00, 7/01, 3/03, 9/07, 3/08, 6/08, 5/10, 5/13, 10/16 Review date: 7/07 Distribution: All Nursing Departments References: 1. American Society of Anesthesiologists; Practice Guidelines for Sedation and Analgesia by Non Anesthesiologists; April American Heart Association; PALS Provider Manual JCAHO-CAMH Update January 2008; Care of Patients, Standards, Intent Statements for Anesthesia Care. 4. Sedation, Anesthesia and The JCAHO, Second Edition, Dean F Smith American Society of Anesthesiologists: JCAHO Compliance Toolkit: Sedation Model Policy American Academy of Pediatrics Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic on Therapeutic Procedures, Sedation from a Nursing Perspective, Christine Schuck, RN, BSN, MSHCA. 8. Society of Gastroenterology Nurses and Associates, Inc., Statement of the Use of Sedation and Analgesia in the Gastrointestinal Endoscopy Setting. 9. ASA Newsletter. 10. American Association of Critical Care Nurses Sedation Guidelines, March Standards of Perianesthesia Nursing Practice. 12. American College of Radiology Practice Guideline for Adult Sedation/Analgesia, 2005.

7 Procedural Sedation (Adult/Pediatric), Page 7 Riker References: 1. Prospective evaluation of the sedation-agitation scale in adult ICU patients. Crit Care Med 1999; 27: Assessing sedation in ventilated ICU patients with the bispectral index and the sedation-agitation scale. Crit Care Med 1999; 27: Confirming the reliability of the Sedation-Agitation-Scale in ICU nurses without prior experience in its use. Pharmacotherapy 2001; 21: Validating the Sedation-Agitation Scale with the bispectral index and visual analog scale in adult ICU patients after cardiac surgery. Intensive Care Med 2001; T:\Data\Policies\CAREPT\cpt4.44r11crk.doc

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9 Procedural Sedation (Adult/Pediatric), Page 8 APPENDIX I Diazepam (Valium TM) CIH ADULT PROCEDURAL SEDATION MEDICATION REFERENCE Drug Dose Administration Technique Potential Adverse Reactions Reversal Agent 2-5mg initially Slowly over 1 minute for each 5 mg injected into Drowsiness, thrombosis and phlebitis at Flumazenil (Romazicon) infusing IV lines. the site of injection, slurred speech, Initially 0.2mg IV; titrate in (20 mg in 60 min. May be repeated every 5 minutes. nausea, bradycardia, hypotension, doses of 0.1 mg 10 mg in 60 min. Dose obese patients based on lean body weight. respiratory depression, skin rash, blurred When given with an opioid.) vision, nystagmus Etomidate (Amidate TM) Administration only by persons trained in the administration of anesthesia. Methohexital (Brevital TM) Midazolam (Versed TM) mg IV or mg/kg IV 1-2 mg initially, then mg as additional doses (5 mg in 35 min.) 1 mg/kg often adequate for cardioversion as a single dose. Stable for 24 hours following dilution. Dose obese patients based on lean body weight. Slowly into an infusing IV line. If level of sedation is not reached, repeat dose in increments. Wait an additional 2-5 minutes to evaluate effects. Somnolence, confusion agitation, nausea, vomiting, hypoxia. Fluctuations in vital signs, apnea, hypotension, hiccoughs, nausea, vomiting, coughing, over sedation, headache, drowsiness. None; supportive measures. Flumazenil (Romazicon) Initially 0.2 mg IV; titrate in dose of 0.1 mg. Lorazepam (Ativan TM) Fentanyl (Sublimaze TM) mg initially, 0.5 mg as additional dose (total 4 mg) may be given 1 micrograms/kg ( micrograms initially, mcg for each additional dose. If necessary, repeat until sedation is achieved or maximum dose is reached. Dose obese patients based on lean body weight. Administer slowly. Allow 5 minutes in between each dose. Dose obese patients based on lean body weight. Slowly over 1-2 minutes into an infusion IV line. Allow 5 minutes in between each dose. Dose obese patients based on lean body weight. Hypotension, CNS depression, hyperexcitability. Respiratory depression, apnea, rigidity, bradycardia, hypotension, hypertension, dizziness, blurred vision, nausea, vomiting, laryngospasm, diaphoresis. Flumazenil (Romazicon) Initially 0.2 mg IV; titrate in doses of 0.1 mg. Naloxone (Narcan) Initially 0.2 mg IV; repeat 0.1 to 0.2 mg IV every two minutes as needed.

10 Procedural Sedation (Adult/Pediatric), Page 9 CIH ADULT PROCEDURAL SEDATION MEDICATION REFERENCE CONTINUED Meperidine (Demerol TM) Morphine Hydromorphone (Dilaudid TM) Thiopental Diprivan (Propofol) Ketamine IV mg IV Administer slowly. Administer each mg over 4-5 minutes. Allow 5 minutes in between each dose. 2-5mg initially, then may repeat in doses of 2-5 mg. (10 mg in 60 minutes). SC, IM, IV 0.5mg (max. 2 mg) initially. May repeat with doses of mg. PO mg. Currently being used for TEE and endoscopy procedures. Otherwise, not the preferred agent. Slowly into an infusing IV line. May repeat the dose every 10 minutes. Dose obese patients based on lean body weight. Administer IV slowly over 2-3 minutes. Allow 10 minutes in between each dose. Dose obese patients based on lean body weight. Administration only by persons trained in the administration of anesthesia. Administration only by persons trained in the administration of anesthesia. Administration only by persons trained in the administration of anesthesia. Drowsiness, respiratory depression, apnea, agitation, seizures, tremors, nausea, vomiting. Hypersensitivity, sedation, drowsiness, convulsions, respiratory depression, hypotension, peripheral circulatory collapse, cardiac arrest, allergic reactions, suppression of cough reflex. Hypotension, nausea/vomiting, CNS depression. Naloxone (Narcan) Initially 0.2 mg IV; repeat 0.1 to 0.2 mg IV every two minutes as needed for respiratory suppression only; not to be used for CNS side effects. Naloxone (Narcan) Initially 0.2 mg IV; repeat 0.1 to 0.2 mg IV every two minutes as needed. Naloxone (Narcan) Initially 0.2 mg IV; repeat 0.1 to 0.2 mg IV every two minutes as needed.. Note: Other procedural sedation medications used will be at the discretion of the anesthesia provider. References 1. Watson DS. Developing a competency-based education program for nurse-monitored sedation. Sem Periop Nursing 1992; (4): Facts and Comparisons, Injectable anesthetics drug shortages. ASHP, August 15, 2002.

11 Procedural Sedation (Adult/Pediatric), Page 10 APPENDIX II Diazepam (Valium TM) 0.5 mg/kg 0.03 mg/kg followed by mg/kg doses if needed. (2.5 mg max initial dose, 5 mg total) CIH PEDIATRIC PROCEDURAL SEDATION MEDICATION REFERENCE Drug Dose Route Potential Adverse Reactions Reversal Agent Reference mg/kg IV (over 3 min) Hypotension, CNS depression, pain Flumazenil (Romazicon) 1 at the injection site mg/kg up to 0.2 mg IV; may 0.02 mg/kg PO Allow 10 minutes in between IV repeat in doses of 0.05 mg/kg up doses. to 1 mg, whichever is lower, Midazolam (Versed TM) Lorazepam (Ativan TM) Fentanyl (Sublimaze TM) Morphine Hydromorphone (Dilaudid TM) mg/kg 0.02 mg/kg/dose. May use smaller dose with IV ( mg/kg) and repeat every 10 minutes as needed and titrate to effect. 1-2 micrograms/kg (50 micrograms max) (1/3 dose for patients <3 months old) mg/kg (10 mg max) 0.05 mg/kg (Neonates) IV, IM 0.01 mg/kg PO mg/kg; maximum dose = 5 mg Rectal IV (over 2 min) PO, rectal PO, IV, IM IV slowly, IM IV, IM, SQ, PO IV, IV slowly, SQ IV, IM, PO Hypotension, CNS depression, paradoxical, hyperactivity, tremor Allow 5 minutes in between each IV dose. CNS depression, hypotension/ Hypertension, bradycardia, myoclonic jerks. Allow 10 minutes in between each IV dose. Chest wall rigidity in neonates, hypotension, CNS depression, nausea, vomiting. Allow 5 minutes in between each IV dose. Nausea, vomiting, constipation, hypotension, bradycardia, increased intracranial pressure, allergy, CNS depression. Allow 10 minutes in between each dose. Nausea/vomiting, CNS depression, hypotension Allow 10 minutes in between each dose. every one minute as needed. Flumazenil (Ramazicon) 0.01 mg/kg up to 0.2 mg IV; may repeat in doses of 0.05 mg/kg up to 1 mg, whichever is lower, every one minute as needed. Flumazenil (Romazicon) 0.01 mg/kg up to 0.2 mg IV; may repeat in doses of 0.05 mg/kg up to 1 mg, whichever is lower, every one minute as needed. Naloxone (Narcan) 0.02 mg/kg IV; may repeat every 1-2 minutes as needed. Naloxone (Narcan) 0.02 mg/kg IV; may repeat every 1-2 minutes as needed Naloxone (Narcan) 0.02 mg/kg IV; may repeat every 1-2 minutes as needed. 2, 3, 1 8 1, 3 1, 3 8

12 Procedural Sedation (Adult/Pediatric), Page 11 CIH PEDIATRIC PROCEDURAL SEDATION MEDICATION REFERENCE CONTINUED Ketamine (Ketalar TM) Chloral hydrate (Nectec TM) Pentobarbital (Nembutal TM) Diprivan (Propofol) 3-5 mg/kg 6-10 mg/kg 8-10 mg/kg Anesthesia Only May be combined with atropine 0.01 mg/kg (0.5 mg max) or glycopyrrolate mg/kg (0.25 mg max) to decrease secretions Chloral hydrate (Nectec TM) 1-6 mg/kg (6 mg/kg max total); Anesthesia Only IM PO Rectal IV Given by Anesthesia only PO, rectal IM, rectal IV Given by Anesthesia Only Laryngospasm, vomiting, dysphoric reactions, contraindicated in increased intracranial pressure Age >7 years increases the occurrence of emergence reaction. Midazolam mg/kg decreases emergence reaction. Tastes bad, GI irritation, hyperactivity, CNS depression Hypoxia, hypotensionbradycardia, CNS depression, nausea, vomiting 100mg or 5 ml maximum in each IM location Administration only by persons trained in the administration of anesthesia. None, supportive measures 1, 3, 6 None, supportive measures 1 None; supportive measures 1, 7, 8 Note: Other procedural sedation medications used will be at the discretion of the anesthesia provider. References: 1. Harriet Lane Handbook: a manual for pediatric house officers, 13 th Edition. Johnson KB, editor. Mosby-Year Book, Inc., St. Louis, MO 1993 pg Cote CJ. Sedation of the pediatric patient: a review. In: Pediatric Clinics of North America. 1994: 41(1): Sacchetti A, Schafermeyer R, Gerardi M, et al. Pediatric analgesia and sedation. Ann Emerg Med 1994; 23L Frankville DD, Spear RM, Dyck JB. The dose of propofol required to prevent children from moving during magnetic resonance imaging. Anesthesiology. 1993; 79: Cauldwell CB, Fisher DM. Sedating pediatric patients: is propofol a panacea? Radiology. 1993: 1B6: White PF, Way WL, Trevor AJ. Ketamine-its pharmacology and therapeutic uses. Anesthesiology. 1982; 56: Straom KD. Campbell JB, Harvey LA, et. Al. IV Nembutal: safe sedation for children undergoing CT. AJR 1988; 151: Taketumo CK, Hodding JH, Kraus DM. Pediatric Dosage Handbook, 6 th Edition, Hudson, Ohio: Lexi-Comp.

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