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Policy and Procedure on Conscious Sedation/Analgesia for Adults from Margo McCaffery and Chris Pasero PAIN: CLINICAL

MANUAL may be duplicated for clinical or educational purposes Note: It is advisable to contact the state board of nursing to determine the scope of practice for members of the nursing staff prior to defining their roles in administering and monitoring conscious sedation/analgesia in your institution. The following policy and procedure is based on the assumption that the state board of nursing/nurse practice act approves the nurses role as described. Policy 1. Conscious sedation/analgesia will be defined as: Combinations of pharmacological agents administered by one or more routes to produce a minimally depressed level of consciousness and satisfactory analgesia while retaining the ability to independently and continuously maintain an airway and respond to physical stimulation and verbal commands (ANA, 1991). 2. Optimal conscious sedation/analgesia is achieved when the patient: maintains consciousness independently maintains his/her airway retains protective reflexes (swallow and gag) responds to physical and verbal commands is not anxious or afraid experiences acceptable pain relief has minimal changes in vital signs is cooperative during the procedure has mild amnesia for the procedure recovers to preprocedure status safely and promptly

3. Almost all therapeutic and diagnostic procedures performed will require analgesia; some will require both sedation and analgesia; a few will require sedation only. Prior to a procedure to insure clear communication, the physician will discuss with other team members the plan to administer or not to administer analgesic and/or sedative agents. The decision to provide analgesia during a procedure will be based on the knowledge of the

likelihood that the procedure is painful. If there is any question whether or not pain is associated with the procedure, the health care team will assume that it is. Analgesic agents will be added if it becomes apparent that a procedure thought not to be associated with pain is causing pain. The decision to add sedation may vary depending on the patients age, condition, and anxiety level. For example, chest tube removal and lumbar puncture may require sedation in addition to analgesia for some patients. Previous experience with a painful procedure may contribute to high or low levels of anxiety about the procedure. For example, a previous painful and frightening experience with lumbar puncture may indicate the need for sedation, whereas a previous experience with minimal discomfort during a lumbar puncture, may negate the need for sedation. The following is a list of procedures for which conscious sedation/analgesia may be warranted. This list is by no means exhaustive. Procedures such as all types of endoscopy, lumbar puncture, and cardioversion Wound care: suturing, dressing changes, incision and drainage of abscesses, burn debridement Minor surgical procedures: dental, podiatric, plastic, and ophthalmic procedures; vasectomy Placement of implanted devices, catheters, and tubes Bone marrow aspiration Reduction and immobilization of fractures Removal of implanted devices and tubes Procedures for which the patient is anxious but must remain as motionless as possible, such as magnetic resonance imaging and computed tomography scan (not usually painful but may occasionally require sedation)

4. Pain will be assessed using the following indicators: Self report, including the use of a preestablished signaling system for patients who will not be able or are afraid they will not be able to verbalize a report of pain Overt physical signs: muscle rigidity, tearing of eyes, facial features, groaning, agitation, and changes in vital signs (The absence of overt physical signs will not be interpreted as an absence of pain.)

5. Level of sedation will be assessed using the following sedation scale: S = Sleep, easy to arouse 1 = Awake and alert 2 = Slightly drowsy, easily aroused 3 = Frequently drowsy, arousable, drifts off to sleep during conversation

4 = Somnolent, minimal or no response to physical stimulation 6. All patients receiving conscious sedation/analgesia will have intravenous access. 7. Emergency equipment and medications, including a fully stocked crash cart with difibrillator, will be immediately available in ever location where conscious sedation/analgesia is administered. 8. Informed consent is required prior to administering conscious sedation/analgesia. The responsible physician will provide the patient with all information considered necessary for obtaining informed consent. The registered nurse (RN) will reinforce the physicians explanation prior to and during conscious sedation/analgesia. 9. Only RNs who are Advanced Cardiac Life Support (ACLS) trained and have validated current competency in the administration and monitoring of conscious sedation/analgesia will administer and monitor conscious sedation/analgesia. (See "Nursing Competency" p. 12.) The RNs role includes the following: Patient education Administration of drugs producing conscious sedation/analgesia under direct supervision of responsible physician Administration of drugs for treatment of the side effects and complications of conscious sedation/analgesia Assessment and monitoring Emergency management Documentation

10. A one-to-one RN to patient ratio will be maintained during the administration of conscious sedation/analgesia. This means that the nurse will have no other responsibilities during the procedure and will not leave the patient unattended or engage in tasks that will compromise continuous monitoring. 11. The responsible physician will be present when conscious sedation/analgesia is initiated and throughout its administration. 12. If the amount of sedation required is likely to produce deep sedation, rendering the patient unable to respond to physical or verbal stimulation and independently maintain an airway, it must be administered and monitored by a trained anesthesia provider, i.e., certified registered nurse anesthetist or anesthesiologist. 13. It is recommended that a trained anesthesia provider be consulted prior to administering conscious sedation/analgesia to patients with any of the conditions or characteristics listed below. To insure patient safety, in some of these cases, it may be wise to ask a trained anesthesia provider to administer the conscious sedation/analgesia or to administer it in a location where anesthesia providers are immediately accessible.

Liver or kidney disease Respiratory compromise Acute narrow angle glaucoma Unstable arrhythmias Young children, infants, neonates Frail, debilitated elderly Possible or confirmed pregnancy, nursing mothers

14. A qualified professional capable of managing the complications associated with conscious sedation/analgesia will remain on site until the patient who has received conscious sedation/analgesia meets the established discharge criteria. (See #15 this section.) 15. Patients who have received conscious sedation/analgesia may be discharged 60 minutes after the last dose of sedative or analgesic drug is administered if all of the established discharge criteria are met. (If a reversal agent is administered, enough time must elapse to insure an adverse reaction will not reoccur.) Variations in these criteria may be warranted and must be approved in writing by the responsible physician. Patient is as alert and orient as baseline Presence of protective reflexes (swallow and gag) Stable vital signs consistent with baseline for 30 minutes after last drug dose Oxygen saturation on room air at least 95% or at baseline for 30 minutes after last drug dose Cardiac rhythm consistent with baseline BP and heart rate within 20 points of baseline or within normal limits Temperature not above 101E F Pain rating < or = to baseline When applicable, no visible site drainage or excessive swelling Patient is able to ambulate as well as he/she was able to ambulate prior to procedure Responsible adult is present to drive patient home and remain with patient the length of two half-lives of the drugs administered for conscious sedation/analgesia (AHCPR, 1992).

Routes of Administration

The intravenous (IV) route is preferred for conscious sedation/analgesia because it has a fast onset of action and absorption is more predictable than it is by the intramuscular, subcutaneous, oral, and rectal routes. It is also easier to titrate doses of IV drugs. Local anesthetics by various routes may be indicated. Oral premedication and preemptive analgesics may also be administered. Pharmacological Agents The mu-agonist opioids, such as morphine, fentanyl, hydromorphone, and meperidine, are administrated most commonly for procedural pain management because they produce the most reliable pain control. Agonist-antagonists, such as nalbuphine and butorphanol, may be occasionally used, but because they have an analgesic ceiling, they are less suitable for procedural pain than the mu-agonist opioids. Prior to administering opioids, the patients history of drug use will be determined. Chemically dependent patients usually require higher than recommended doses of opioids. There is no analgesic ceiling with the mu-agonist opioids so doses should be adjusted to meet patients individual requirements. Agonist-antagonist opioids will not be used in patients who have been receiving opioids prior to a procedure because of their potential to reverse analgesia and precipitate a withdrawal syndrome. Response to pharmacological agents is highly individual; therefore, all pharmacological agents will be titrated according to the patients response. The adage "start low and go slow" is applicable. Large bolus doses will be avoided and once desirable levels of analgesia and sedation are achieved, doses will be steadily controlled to maintain those levels. When excessive sedation is detected during a procedure and an opioid is the only agent being administered, the opioid dose must be decreased. Combining drugs, such as benzodiazepines and opioids, may potentiate adverse effects, such as sedation and respiratory depression; therefor, when they are combined, initial doses of both should be decreased. When a benzodiazepine and an opioid are combined and excessive sedation occurs during a procedure, it is recommended that the dose of the benzodiazepine be decreased before decreasing the dose of the opioid. (Since benzodiazepines have no analgesic properties, decreasing the dose will not affect pain control. However, if the opioid dose is decreased first, pain control could be lost. Since opioids provide sedation as well as analgesia, a desirable level of sedation and pain control can often be achieved in this type of situation by simply decreasing the benzodiazepine dose while maintaining the opioid dose.) The doses listed below are intended merely as reference points: 1. Anesthetic Agents Local Anesthetics: local infiltration, regional nerve blocks, and topical administration Propofol (Diprivan): short-acting hypnotic; at subanesthetic doses, has no analgesic properties; administered by the IV route; Onset: 40 sec; Peak: unknown; Duration: 3-5 min; Half-life: 3-12 hr (Deglin and Vallerand, 1993). Propofol should be administered under the direction of physician who has demonstrated competency in administering propofol and is usually limited to use in critical care areas only.

2. Opioids Morphine (IV): 1-2 mg increments over a 30-second period every 5-10 minutes. Onset: rapid; Peak: 20 min; Half-life: 2-3 hr (Deglin and Vallerand, 1993). Fentanyl (Sublimaze) (IV): 0.05-2 : g/kg; dilute 10 : g/ml; administer doses very slowly over 2-5 min; 25-100: g increments every 10 to 15 minutes. Rapid IV injection may cause "rigid chest" treated with muscle relaxant and mechanical ventilation. Onset: 1-2 min; Peak: 3-5 min; Half-life: 3.6 hr. Oral Transmucosal Fentanyl Citrate (OTFC): dosed by sucking on unit dose lozenge on a stick; available in 200 : g, 300 : g, and 400 : g dose strengths; indicated in monitored hospital setting as a premedication (Wong, 1996). Hydromorphone (Dilaudid) (IV): 0.1-0.5 mg increments over 30 second period every 5-10 minutes. Onset: rapid (Hardman and Limbird, 1996); Peak: 15-30 min; Half-life: 2-4 hr (Deglin and Vallerand, 1993). Meperidine (Demerol) (IV): dilute 10 mg/ml saline and administer in 10 mg increments over 30 second period every 5-10 minutes; inject slowly as meperidine can be painful on injection. Onset: immediate; Peak: 5-7 min; Half-life: 3-8 hr (Deglin and Vallerand, 1993).

3. Benzodiazepines: diminish skeletal muscle spasm, reduce anxiety, and produce amnesia at high doses but lack analgesic properties for acute tissue injury. If pain is associated with the procedure or condition, an analgesic must be added (AHCPR 1992). Midazolam (Versed) (IV): dilute 1 mg/ml saline or 5% dextrose; reduce dose by a third when combining with an opioid; 0.5-1 mg increments; allow at least three minutes between initial doses to assess full effect. No more than 2.5 mg should be administered over a period of three minutes. Once sedation is achieved, additional doses should be 25% of the dose required to produce the sedative end-point. A total dose of > 5 mg is usually not necessary. Maintenance dose is 0.25-1 mg. Onset: 1-5 min; Peak: rapid; Duration: 2-6 hr; Half-life: 1-12 hr (Deglin and Vallerand, 1993). Midazolam has a rapid onset of action and short half-life and is not associated with pain at the site of injection. It is 3-4 times more potent per milligram than diazepam. Midazolam is recommended as a replacement for diazepam as the drug of choice for conscious sedation (Lee, Hanna, and Harding, 1989), induction, and maintenance of anesthesia (Hardman and Limbird, 1996). Diazepam (Valium) (IV): reduce dose by a third when combining with an opioid; 1-5 mg increments to 20 mg/hr maximum dose. Onset: 1-5 min; Peak: 15-30 min; Duration: 15-60 min; Half-life: 20-70 hr (Deglin and Valerand, 1993). Valium is associated with great variation in response, prolonged action with a second peak effect at six to eight hours, pain on injection, and thrombophlebitis at the site of injection (Hardman and Limbird, 1996; Lee, Hanna, and Harding, 1989). Lorazepam (Ativan) (IV): reduce dose by a third when combining with an opioid; dilute 1:1 in compatible solution immediately before administering; 0.05 mg/kg to 4 mg

maximum total dose. Onset: 5-15 min; Peak: unknown; Duration: up to 48 hr; Half-life: 10-20 hr (Deglin and Vallerand, 1993). The long half-life of lorazepam makes midazolam a preferable choice. 4. Reversal Agents Naloxone (Narcan) (IV) for opioids: dilute 0.4 mg in 10 ml saline and administer by a titration-to-effect technique, i.e., no more than 0.5 ml over two minutes, up to 0.8 mg (APS, 1992). Flumazenil (Romazicon) (IV) for benzodiazepines: administer by titration-to-effect technique; 0.2 mg given over 15 seconds. After waiting 45 seconds, an additional 0.2 mg may be given and repeated at 60-second intervals up to 1 mg. Can cause life-threatening seizures in patients receiving benzodiazepines on a long-term basis and in patients who have overdosed on barbiturates or tricyclic antidepressants (Hardman and Limbird, 1996). Most anesthetic agents: discontinue administration immediately and wait for effect to dissipate.

Equipment Fully equipped crash cart, including emergency and resuscitative drugs, airway and ventilatory equipment, and defibrillator in all locations where conscious sedation/analgesia is administered. Electrocardiogram (ECG) monitor with display Noninvasive blood pressure (BP) monitor Oximetry monitor Means to monitor body temperature Stethoscope 100% oxygen source and administration supplies Airways and positive pressure breathing device in room Suction source and supplies IV supplies Sedative, analgesic, and reversal agents

Procedure (Preparation Phase) 1. Insure all supplies and equipment to be used for the administration and monitoring of conscious sedation/analgesia and emergency management are fully stocked and functional.

2. Review patients history and physical information to determine current condition; chief complaint; reason for conscious sedation/analgesia; and any risk factors of contraindications to receiving conscious sedation/analgesia. 3. Determine current medications patient is taking; existence of allergies; history of drug use or abuse, including tobacco and alcohol; adverse experience with anesthesia, sedatives, or analgesics; and last oral intake. 4. Reinforce physicians explanations of procedure to patient and family. Patient education includes discussing the following important points: Purpose and goal of conscious sedation/analgesia Procedure for administering conscious sedation/analgesia Sensations patient may experience Assessment and monitoring Pain assessment, use of pain rating scale, use of a signaling system for patients who will not be able to verbalize a report of pain Pain relief interventions Drugs to be administered Side effects and complications and their treatment Patients and familys roles Physicians and nurses roles Post recovery expectations and instructions

-Post procedure sensations patient may experience -Resumption of medications taken prior to procedure -Review of new prescriptions -Wound care -Diet and activity restrictions, including a warning that the patient is not to drive or operate dangerous machinery for at least 24 hours. -Follow up care Review of written materials

5. If conscious sedation/analgesia is performed in the outpatient setting, insure that a responsible person is available to drive the patient home after recovery and that a responsible person will

remain with the patient the length of two half-lives of the drugs administered for conscious sedation/analgesia (AHCPR 1992). 6. Insure written consent is obtained. 7. Attach monitoring equipment to patient (ECG, BP, oximetry). 8. Obtain and document baseline data on patient: temperature; heart rate and rhythm; respiratory status, including oxygen requirements, depth of respirations, breath sounds, and oxygen saturation; blood pressure; skin condition; level of sedation and mental status; ability to ambulate; weakness and/or sensory loss in extremities (if indicated); and description and intensity of any current painful condition. 9. Insert IV line and regulate continuous infusion at a keep-open rate. 10. Prepare all drugs to be administered, including readying reversal agents for possible administration. Procedure (Administration Phase) 1. Administer pharmacological agents under direct supervision of responsible physician. Begin administration of sedative or analgesic drugs only when responsible physician is present. 2. Continuously observe and document patient responses to conscious sedation/analgesia: ECG, BP, and oxygen saturation every five minutes Ausculation of breath sounds and observation of respiratory depth and rate every five minutes Level of sedation and mental status every five minutes Skin color and condition ever 10 minutes Pain rating every 10 minutes

Note: Determining some of the monitoring parameters as frequently as outlined above may not be possible during some procedures. For example, if the purpose of conscious sedation/analgesia is to help the patient remain as still as possible, frequent inflation of the BP cuff may stimulate the patient and prove to be counterproductive. In these cases, close observation and monitoring of other parameters is invaluable. 3. Provide reassurance and emotional support throughout the procedure. 4. Inform the physician immediately of adverse response or any significant changes in baseline parameters. 5. Maintain continuous IV access. 6. Perform emergency management procedures if necessary.

Procedure (Recovery Phase) 1. Continue mechanical monitoring: ECG, BP, oxygen saturation. 2. Assess and document vital signs, skin condition, level of sedation and mental status, and pain every 15 minutes for at least 60 minutes after the last sedative or analgesic drug dose is given and until discharge criteria is met. 3. Maintain IV access for at least 60 minutes after last sedative and analgesic drug dose is given and until discharge criteria are met. 4. Review discharge instructions. Nursing Competency 1. RNs will meet the following requirements prior to administering and monitoring conscious sedation/analgesia: Validated current ACLS training Validated current competency in the administration and monitoring of conscious sedation/analgesia. Validation is achieved by successfully completing a learning module and post-test. Additionally, the RN will be able to demonstrate satisfactory performance in the operation of any equipment that is or may be used to administer conscious sedation/analgesia and manage its side effects and complications. The RN will be required to validate annually.

2. Recommended components of the conscious sedation/analgesia learning module include but are not limited to the following: Definitions, differences between, and scope of nursing practice with regard to analgesia, conscious sedation, deep sedation, and anesthesia Goal and purpose of conscious sedation/analgesia Review of institutional protocol for administering and monitoring conscious sedation/analgesia Procedures for which conscious sedation/analgesia is commonly administered Patient selection criteria Guidelines and indications for adding analgesia to sedation Patient advocacy Informed consent Patient teaching and discharge planning Pharmacology and pharmacokinetics of drugs administered for conscious sedation/

analgesia and its side effects and complications, including routes of administration and recommended doses Assessment, monitoring, care, and documentation during all phases of procedure Equipment operation Emergency management

References Acute Pain Management Guideline Panel. Acute pain management: operative or medical procedures and trauma. Clinical practice guideline. AHCPR Pub. No. 92-0032. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services. Feb. 1992. American Association of Nurse Anesthetists (AANA): Qualified providers of conscious sedation: AANA position statements, Park Ridge, IL, 1991, AANA. American Nurses Association (ANA): Position statement: the role of the registered nurse in the management of patients receiving intravenous conscious sedation for short-term therapeutic, diagnostic, or surgical procedures, Kansas City, MO 1991, ANA. For copy, contact ANA (816) 474-5720. American Pain Society (APS): Principles of analgesic use in the treatment of acute pain and cancer pain, ed 3, Skokie, IL, 1992, APS. American Society of Post Anesthesia Nurses (ASPAN): Standards of post anesthesia nursing practice, Richmond, VA, 1991, ASPAN. Association of Operating Room Nurses (AORN): Proposed recommended practice: monitoring the patient receiving intravenous conscious sedation, AORN J 56:316-324. Deglin JH and Vallerand AH: Daviss drug guide for nurses, ed 3, Philadelphia, 1993, F.A. Davis. Drug facts and comparisons, St. Louis, 1996, Wolters Kluwer. Hardman JG and Limbird LE, editors: Goodman and Gilmans the pharmacological basis of therapeutics, ed 9, New York, 1996, McGraw-Hill, Inc. Jacox A, Carr DB, Payne R, and others: Management of cancer pain. Clinical practice guideline No. 9. AHCPR Publication No. 94-0592, Rockville, MD, Agency for Health Care Policy and Research, U.S. Department of Health and Human Services, Public Health Service, March 1994. Lee MG, Hanna W, and Harding H: Sedation for upper gastrointestinal endoscopy: a comparative study of midazolam and diazepam, Gastrointestinal Endoscopy, 35(2): 82-84, 1989. Somerson SJ, Husted CW, and Sicilia MR: Insights into conscious sedation, Am J Nurs 95(6):26-33, 1995.

Wong D: Wong and Whaleys clinical manual of pediatric nursing, ed 4, St. Louis, 1996, Mosby-Year Book, Inc. McCaffery and Pasero 1996; may be duplicated for clinical or education purposes from McCaffery