ASPMN is in a strategic position to make recommendations as members have:

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1 Expert Consensus Panel for Monitoring of Opioid-induced induced Sedation and Respiratory Depression: Summary Report of Findings and Preliminary Recommendations ASPMN Annual Meeting, 2009 Jacksonville, Florida Expert Consensus Panel Members Donna Jarzyna, Chairperson Iatrogenic Risk Donna Jarzyna, MS, CNS-BC, RN-C Thomas Quinn, MSN, RN, AOCN High Risk Patient Carla Jungquist, PhD, RN-C Rosemary Polomano, PhD, RN, FAAN Diane Santangelo, MS, RN, ANP-BC Monitoring Allison Nisbet, MSN, RN-BC, CPN, AOCNS Linda Oakes, MSN, RN-BC, CCNS Susan Dempsey, MN, RN-BC, CNS Pharmacologic Chris Pasero, MS, RN-BC, FAAN Joyce S.Willens, PhD, RN-BC Development of the Consensus Panel Effective Pain Care is a Patient Right Opioid analgesia is the primary pharmacologic intervention for acute pain There is heightened awareness nationally of institutional safety issues related to opioid analgesia In 2007, the ASPMN Board of Directors approved the formation of an expert panel to develop consensus recommendations based upon the strength of the literature for monitoring of opioid-induced sedation and respiratory depression Why should ASPMN develop the Standards of Practice? ASPMN is in a strategic position to make recommendations as members have: 1. Advanced education in pain management 2. Evidence of nationally recognized scholarship and accomplishments 3. Diverse expertise in clinical practice, education and research Why should standards be developed? Challenges in defining practice standards for safe patient monitoring practices o little direction in the use of technology in patient monitoring o significant expenses are incurred with emphasis on technology for monitoring o positive outcomes may not be achieved with these technologies o other disciplines have defined our practice (Anesthesia Patient Safety Foundation, ) o guidelines development by ASPMN preempt others from imposing guidelines upon our practice Populations of Focus for the Review Hospitalized adults receiving opioid analgesics for pain management excluding sedation in critical care settings procedural sedation practices 1

2 Consensus Panel Responsibilities Panel Summary Report Conduct an extensive literature review Conduct a survey of ASPMN members Grade and summarize published evidence Formulate preliminary recommendations based on evidence and expert consensus Details of literature review Preliminary consensus recommendations on monitoring patients receiving opioid-based therapies Report findings from the membership survey (presented in a concurrent session on Monday 9/14/09, 9:30-10:30 am) Categories for Evidence-based Findings Individual Risk Factors Iatrogenic Risk Pharmacological Effects Methods of Monitoring Expert Consensus Panel for Monitoring of Opioid-induced induced Sedation and Respiratory Depression The High Risk Patient Carla Jungquist, FNP-C, PhD University of Rochester Rochester, NY Category A Meta-analyses, Systematic Reviews, RCT Category B Observational Cohort Studies Category C Equivocal studies that cannot determine beneficial or harmful relationships Category D Insufficient Evidence or No Studies Opinion-Based Evidence Practice Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea Gross JB, et al. Anesthesiology. 2006; 104(5): Preoperative Pulmonary Risk Stratification for Noncardiothoracic Surgery: Review for the American College of Physicians Smetana GW, et al. Ann Intern Med. 2006;144(8):

3 Focus of Review of the Literature Sleep Disordered Breathing 1. Sleep disordered breathing as a risk factor 2. Risk factors for postoperative pulmonary complications Obstructive Sleep Apnea Central Sleep Apnea Obstructive Sleep Apnea Risk Factors (7-14% of males and 2-7% of females) Male Older than 55 years BMI >30 Neck circumference >17.5 Mallampati Class 3 & 4 Retrognathia Snores Witnessed periods of apnea Hypertension FlemonsWW, et al. Amer J of Resp and Critical Care Med. 1994; 150: GuilleminaultC & BassiriA. P & P Sleep Medicine, 4th ed. pp Martinez-Rivera C, et al. Obesity. 2008; 16(1): Young T, et al. Sleep. 2002; 28(3): Heuss LT, et al. Gastrointestinal Endoscopy. 2003; 57(6): Tsai WH, et al. Amer J of Resp and Critical Care Med. 2003;167(10): Obstructive Sleep Apnea Mallampati Class Class 1 Entire tonsil clearly visible Class 2 Upper half of tonsil fossa visible Class 3 Soft and hard palate clearly visible Class 4 Only hard palate visible NucktonTJ, et al. Sleep. 2006; 29: Epworth Sleepiness Scale (ESS) Situation Chance of dozing (0-3) Sitting and reading Watching television Sitting inactive in a public place - for example, a theater or meeting As a passenger in a car for an hour without a break 0 = would never doze 2 = moderate chance of dozing 1 = slight chance of dozing 3 = high chance of dozing Lying down to rest in the afternoon Sitting and talking to someone Sitting quietly after lunch (without alcohol) In a car, while stopped in traffic Total Score Central Sleep Apnea Risk Factors Cardiac disease Pulmonary disease Age >65 Medications such as opioids Rupprecht, S, et al. Sleep. 2008; 9(4): 464. Strassburg, A., et al. Internat J of Cardiology. 2008;126(3): Szollosi, I et al. Chest. 2008; 134(1): Wang, D & Teichtahl, H. Sleep Med Reviews. 2007;11(1): ESS total score 10 indicates possible excessive sleepiness or sleep disorder Johns MW. Sleep. 1991;14:

4 Risk Factors for Postoperative Pulmonary Complications Predictors of pulmonary complications during the postoperative period can be divided into five categories: 1. Individual characteristics 2. General state of health 3. Presence of certain diseases 4. Type of anesthesia 5. Type of surgical procedure ArozullahAM, et al. Ann Surg. 2000; 232(2): Lai HC, et al. British Journal of Anaesthesia. 2007; 99(2): Reilly DF, et al. Arch Intern Med. 1999;159: Wolters U, et al. Br J Anaesth. 1996; 77(2): Risk Factors for Postoperative Pulmonary Complications Individual characteristics and general health Age >70 (2.6 x more like to have respiratory failure than <50) Albumin <30g/L (2.16 x more likely than >40g/L) BUN >30mg/dL (2.09 x more likely than <20mg/dL) Dependent functional status (total dependence 2.24 x more likely than independent) Presence of certain diseases ASA classification >2 COPD (1.58 x more likely) CHF (1.25 x more likely) Arozullah, AM, et al. Ann Surg. 2000; 232(2): Reilly DF, et al. Arch Intern Med. 1999; 159: Wolters U, et al. Br J Anaesth. 1996; 77(2): Risk Factors for Postoperative Pulmonary Complications Type of Anesthesia General (1.9 x more likely than spinal anesthesia) Prolonged Emergency surgery (2.81 x more likely than non-emergent) Type of surgical procedure Abdominal aortic abdominal repair (11 x more likely) Thoracic surgery (5.91 x more likely than light surgery) Neurosurgery (2.96 x more likely) Upper abdominal surgery (3.36 x more likely) Peripheral vascular surgery (3.4 x more likely) Neck surgery (2.13 x more likely) ArozullahAM, et al. Ann Surg. 2000; 232(2): Reilly DF et al. Arch Intern Med. 1999; 159: Wolters U, et al. Br J Anaesth. 1996; 77(2): American Society of Anesthesiologist s Classification for Physical Status Class I Class II Class III Class IV Class V Class VI Normal Healthy Patient with mild systemic disease Pt. w/severe systemic disease Pt. w/ severe systemic disease that is a threat to life. (4.26 more likely than Class I to develop a post operative cardiac or pulmonary complication) Morbid pt. who is not expected to survive without the operation A declared brain dead pt. whose organs are being removed for donor purposes Wolters U, et al. Br J Anaesth. 1996; 77(2): Expert Consensus Panel for Monitoring of Opioid-induced induced Sedation and Respiratory Depression Iatrogenic Risk Donna Jarzyna, RN-C, MS, CNS-BC University Medical Center Tucson, Arizona Definition of Iatrogenic The conditions, circumstances and interventions that predispose a patient to increased risk for unintended advancing sedation or respiratory insufficiency 4

5 Focus of Review of the Literature Continuous Epidural and PCA Timing and Staffing Pain Team Oversight Continuous peripheral nerve block; Continuous wound infusion; Intrapleural infusion; } Handoff communication Category A Meta-analyses, Systematic Reviews, RCT Category B Observational Cohort Studies Category C Equivocal studies that cannot determine beneficial or harmful relationships Category D Insufficient Evidence or No studies Opinion-Based Evidence Delivery modality Timing Communication variables Environment and staffing Oversight Definition of Neuraxial Delivery modality: Neuraxial refers to the delivery of either a spinal or an epidural opioid which can be: single injection epidural continuous infusion epidural extended-release epidural preparation lipophilic versus hydrophilic opioid lower versus high dose opioid intrathecal delivery intracerebroventricular delivery ASA Neuraxial Guidelines The neuraxial summary has been synthesized from guidelines developed by the American Society of Anesthesiologists Task Force on Neuraxial Opioids comparing the risk of neuraxial therapy to parenteral therapy (IV, IM, SQ) HorlockerT, et al. Anesthesiology. 2009;110 (2); Comparison of Risk Neuraxial versus Parenteral Comparison of Risk Neuraxial versus Parenteral The risk of respiratory depression is similar for parenteral opioid administration and Single injection neuraxial opioid administration (Category C-1 evidence) Extended-release epidural morphine (Category C-1 evidence) The risk for respiratory depression is less with continuous epidural opioid infusion than with parenteral opioid administration (Category A-1 evidence) The risk of respiratory depression is greater with intracerebroventricular opioid administration than with parenteral opioid administration (Category B-1 evidence) 5

6 Monitoring with Neuraxial Opioid Therapy Increased monitoring for adequacy of ventilation is warranted in patients at risk for respiratory depression Monitoring should be dictated by: the patient s overall condition concurrent medication being administered Supplemental Opioid Administration Research is lacking with regard to the risk of respiratory depression associated with supplemental opioid administration during local anesthetic delivery via: continuous peripheral nerve block continuous infusions into the wound intrapleural infusion HorlockerT, et al. Anesthesiology. 2009;110 (2); Liu SS, et al. AnesthAnalg. 2007;104(3): Comparison of Risk IM, IV, SQ, Oral versus PCA Factors Increasing the Risk of Respiratory Depression with PCA The risk of adverse respiratory effects are similar between IV PCA and conventional opioid analgesia The use of a basal infusion with PCA Rapid dose escalation Patient age Specific surgeries Unauthorized staff or family activation HudcovaJ, et al. Cochrane Database SystRev (4) CD Fleming BM, et al. J Pain Symptom Manage.1992; 7(8): Sidebotham D, et al. J Pain Symptom Manage. 1997;14(4): Period of Highest Risk Hand-Off Communication Postoperative day 1or the first 24 hours Taylor L, et al. Am J of Surgery. 2005; 190: The night shift (between 2300 and 0700 hours) Schmid-Mazzoccoli et al. Qual Saf Health Care. 2008;17(5): Although hand-off communication is recommended by the Joint Commission, there is inadequate evidence to determine the effects or to recommend a specific type of hand-off communication Carroll T. NursAdmin Q. 2006; 30(3): Haig K. J Qual Patient Safety. 2006; 32(3)

7 Staffing Pain Team Oversight Higher registered nurse staffing is associated with less hospital-related mortality and decreased rates of failure to rescue Aiken LH, et al. JAMA. 2003; 290(12): Kane, et al. AHRQ Pub No. 07-E Comparison of 8 to 12 hour shifts, no difference has been demonstrated in patient outcomes Stone PW, et al. Medical Care. 2006; 44(12) Limited literature The literature is difficult to interpret because of the lack of consistent operational definitions of a Pain Team More research is needed to evaluate the impact of care delivery by pain teams or services Silber JH, et al. Anesthesiology. 2009; 93(1): Story DA, et al. Anaesthesia. 2006; 61(1): Environment and Staffing Environment and Staffing The risk for delay of treatment increases with the following: facilities performing lower volumes of procedures unit placement mismatch The risk for delay of treatment increases with the following: decreased educational preparation of nursing staff poorer nursing practice environment Smith DL, et al. Ann SurgOnc. 2007;14(6): Schmid-Mazzoccoli et al. Qual Saf Health Care. 2008;17(5): Kane, et al. AHRQ Pub No. 07-E Friese CR, et al. Health Serv Res. 2008; 43(4): Summary Multiple variables influence risks for sedation and opioid-induced respiratory depression Awareness of environment, practice patterns and monitoring of facility specific opioid-induced respiratory depression will assist with strategic planning to support safe care (remember the 4 P s) Practice environment Practice policies Practice patterns Monitoring practices 7

8 Expert Consensus Panel for Monitoring of Opioid-induced induced Sedation and Respiratory Depression Pharmacology Chris Pasero, MS, RN-BC, FAAN Educator and Clinical Consultant El Dorado Hills, California Focus of Review of the Literature Opioids Nonopioids (acetaminophen, NSAIDs) Anticonvulsants Antidepressants Alpha 2 agonists (clonidine, dexmedetomidine) NMDA receptor antagonists (ketamine) Opioid Analgesics Category A Meta-analyses, Systematic Reviews, RCT Category B Observational Cohort Studies Category C Equivocal studies that cannot determine beneficial or harmful relationships Category D Insufficient Evidence or No studies Opinion-Based Evidence Pharmacology Opioid Analgesics Drugs that bind to opioid receptors in the peripheral and central nervous systems to produce analgesia sedation mechanisms are poorly understood; clinical effect from CO 2 accumulation respiratory depression results from binding to opioid receptors in the pontine and ventral medulla of the brain stem Literature reviewed to identify differences among the opioids in their potential to produce clinically significant sedation and respiratory depression Findings Opioid Analgesics Category C2 evidence: the very small amount of research that has been conducted is equivocal with regard to differences among the various opioids in terms of their sedative and respiratory depressant effects A critical lack of high-quality comparative research precludes any evidence-based conclusions about differences among the various opioids Randomized controlled trials that compare the opioids and include clear definitions are needed Bernards CM, et al. Anesthesiology. 2009; 110(1): Chang AK, et al. Ann EmergMed. 2006; 48(2): Choi SH, et al. Yonsei Med J. 2008; 49(2): Hutchison RW, et al. Hosp Pharm. 2006; 41(7): Non-Opioid Analgesics Category A Meta-analyses, Systematic Reviews, RCT Category B Observational Cohort Studies Category C Equivocal studies that cannot determine beneficial or harmful relationships Category D Insufficient Evidence or No studies Opinion-Based Evidence 8

9 Pharmacology Nonopioid Analgesics Acetaminophen: underlying mechanisms of analgesia are not entirely clear but are thought to be both peripherally and centrally mediated NSAIDs: produce analgesia by blocking prostaglandins through inhibition of cyclooxygenase (primary mechanism) Do acetaminophen or NSAIDs reduce opioid- induced sedation or respiratory depression? Research was either insufficient or did not show that acetaminophen reduces opioid-induced sedation or respiratory depression NSAIDs reduce opioid-induced sedation Differences in definitions and a general lack of reporting on the incidence of respiratory depression prevented conclusions about whether or not NSAIDs reduce respiratory depression Remy C, et al. Br J Anaesth. 2005; 94(4): Elia N, et al. Anesthesiology. 2005;103(6): Liu SS, Wu CL. Anesth Analg. 2007;104(3): Liu SS, Wu CL. Anesth Analg. 2007;105(3): Pharmacology Adjuvant Analgesics anticonvulsants, ketamine, & clonidine dexmedetomidine antidepressants Category A Meta-analyses, Systematic Reviews, RCT Category B Observational Cohort Studies Category C Equivocal studies that cannot determine beneficial or harmful relationships Category D Insufficient Evidence or No studies Opinion-Based Evidence Anticonvulsants: blocks sodium and calcium channels Antidepressants: blocks reuptake of 5HT and NE Ketamine: antagonizes activity at the NMDA receptor; inhibits abnormal pain processing Clonidine: binds to alpha 2 receptors in the CNS to block the release of neurotransmitters Dexmedetomidine: 8 times stronger affinity for alpha 2 receptors than clonidine Do these adjuvant analgesics reduce opioid-induced induced sedation or respiratory depression? Anticonvulsants increase sedation; no increase in respiratory depression when added to treatment Ho KY, Gan TJ, Habib AS. Pain. 2006;126(1-3): Mathiesen O, Moiniche S, Dahl JB. BMC Anesthesiology. 2007; 7:6. Peng PW, Wijeysundera DN, Li CC. Pain Res Manag. 2007;12(2): Tiippana EM, et al. Anesth Analg. 2007;104(6): Ketamine neither increases nor decreases sedation or respiratory depression when added to treatment Elia N, Tramer MR. Pain. 2005;113(1-2): Subramaniam K, et al. Anesth Analg. 2004; 99(2): Clonidine at greater than 150 mcg increases sedation; respiratory depression was not reported Elia N, et al. Reg Anesth Pain Med. 2008; 33(2): Ilfeld BM, et al. Anesth Analg. 2005; 100(4): Martney CJL, Duggan E,,Apatu E. Reg Anesth Pain Med. 2007; 2(4): Do these adjuvant analgesics reduce opioid-induced induced sedation or respiratory depression? A single RCT showed no difference in sedation and respiratory depression in those who received dexmedetomidine+ opioid and those who received opioid alone Lin TF, et al. Br J Anaesth. 2009; 102(1): Insufficient evidence regarding the effect of antidepressants on opioid-induced sedation and respiratory depression Fridrich P, et al. J Pain. 2007; 8(7): Wordliczek J, et al. Pol J Pharmacol. 2001; 53:

10 Expert Consensus Panel for Monitoring of Opioid-induced induced Sedation and Respiratory Depression Monitoring Allison Nisbet, MSN, RN-BC, CPN, AOCNS Inova Fairfax Hospital Falls Church, Virginia Pulse oximetry Nurse/Scales End-Tidal CO 2 Nurse Category A Meta-analyses, Systematic Reviews, RCT Category B Observational Cohort Studies Category C Equivocal studies that cannot determine beneficial or harmful relationships Category D Insufficient Evidence or No studies Opinion-Based Evidence Expert Panel Definitions Continuum of Consciousness Opioid-induced sedation represents a continuum of levels of consciousness and arousability ideally measured by reliable and valid criteria that are applied in clinical practice for safe and effective administration of opioid analgesics Opioid-induced respiratory depression is a concerning decrease in the effectiveness of an individual s ventilatory function following opioid administration Maintains airway independently Awake, baseline Anxiolysis Anti-Anxiety Moderate sedation Does NOT maintain airway Deep sedation General anesthesia Advancing sedation precedes respiratory depression Monitoring Concepts Nursing assessment: Use sedation scales and/or technology to recognize changes in sedation level or respiratory status Sedation Scale: Used to recognize distinct changes in level of alertness and arousability Technology: Used to recognize changes in ventilation and oxygenation which indicate respiratory status Focus of Review of the Literature Monitoring clarification The use of available technologies to determine early decreases in oxygenation pulse oximetry (SpO 2 ) end-tidal carbon dioxide monitoring (EtCO 2 ) Methods used by the nurse to report opioid effects on sedation respiratory status 10

11 Technology Pulse Oximetry (SpO 2 ) Not associated with significant reduction in the need to return postoperative patients to ICU, mortality, or estimated total costs Ochroch EA, et al. Anesth Analg. 2006; 102: Did detect hypoxic states, but its use cannot be generalized due to small study samples Pedersen et al. Anesth Analg. 2003; 96: Technology Pulse Oximetry (SpO 2 ) Factors that limit accuracy and clinical utility of SpO 2 Patients with darker skin Bickler PE, et al. Anesthesiology. 2005; 120(4): Patients receiving supplemental oxygen Fu E, et al. Chest. 2004; 126: Technology End Tidal Carbon Dioxide Monitoring (ETCO 2 ) Considered to be an early indicator of respiratory compromise: Upper airway obstruction Respiratory depression Apnea Able to detect respiratory compromise PRIOR to desaturation or observed hypoventilation Burton JH, Harrah JD, Germann CA, et al. Acad Emerg Med. 2006;13: Patients over 65 years of age were more likely to have bradypnea, whereas morbidly obese and patients receiving continuous infusions of opioids were less likely to have bradypnea Overdyk FJ, Carter R, Maddox RR, et al. Anesth Analg. 2007;105: Nursing Assessment Sedation Scales Limited research on the role of the nurse Most sedation assessment scales validated in critical care or procedural sedation settings purpose: goal-directed purposeful sedation agitation measured - confounding construct examples: RASS, Aldrete, etc. Nursing Assessment Sedation Scales Two recent studies evaluating sedation scales outside of the purposeful sedation setting Richmond Agitation & Sedation Scale (RASS) Pasero Opioid-induced Sedation Scale (POSS) The Pasero Opioid-induced Sedation Scale (POSS) found to be most applicable in the nonpurposeful sedation setting POSS found to have higher reliability in this setting POSS found to result in more frequent correct score and subsequent clinical actions by the nurse Sessler, CN, et al. Am J Resp Crit Care Med. 2002;166(31): Dempsey SJ, et al. National Assoc of Orthopedic Nurses Congress, Tampa, FL Nisbet, A & Mooney-Cotter, F (2009, Sept) Pain Manag Nurs. In press. 11

12 Pasero Opioid-induced Sedation Scale (POSS) S = Sleep, easy to arouse Acceptable; no action necessary; may increase opioid dose if needed 1 = Awake and alert Acceptable; no action necessary; may increase opioid dose if needed 2 = Slightly drowsy, easily aroused Acceptable; no action necessary; may increase opioid dose if needed 3 = Frequently drowsy, arousable, drifts off to sleep during conversation Unacceptable; monitor respiratory status and sedation level closely until sedation level is stable at less than 3 and respiratory status is satisfactory; decrease opioid dose 25% to 50% 1 or notify prescriber 2 or anesthesiologist for orders; consider administering a nonsedating, opioid-sparing non-opioid, such as acetaminophen or a NSAID, if not contraindicated 4 = Somnolent, minimal or no response to verbal and physical stimulation Unacceptable; stop opioid; consider administering naloxone 3,4 ; notify prescriber 2 or anesthesiologist; monitor respiratory status and sedation level closely until sedation level is stable at less than 3 and respiratory status is satisfactory Nursing Assessment Sedation Scales Study outcomes support previous anecdotal observations in the literature use of sedation scales tested in purposeful sedation settings are inappropriate for sedation assessment for patients receiving opioids for pain management in which sedation may lead to clinically significant respiratory depression Pasero C & McCaffery M. AJN. 2002;102(2): Quinn, T. Orlando, Florida: Annual Meeting of the ASPMN; Smith LH. Clinical Journal of Oncology Nursing, 2007;11(2): Copyright 1994, Chris Pasero. Used with permission. Source: Pasero C: Acute Pain Service: Policy and Procedure Manual. Los Angeles, CA Academy Medical Systems, Reprinted with permission. Monitoring for Opioid-induced induced Sedation and Respiratory Depression: Preliminary Recommendations from the ASPMN Expert Consensus Panel Summary of Recommendations Donna Jarzyna RN-C, MS, CNS-BC University Medical Center Tucson, Arizona Disclaimer: The preliminary recommendations put forth at this time represent agreement among members of the ASPMN Expert Consensus Panel for Monitoring of Opioid-induced Sedation and Respiratory Depression. These recommendations have not been finalized or subjected to a thorough external peer review process to ensure their accuracy, completeness and relevance to practice. Final approval by the ASPMN Board of Directors has not been granted, and therefore, these recommendations must not be disseminated, implemented or referenced as authoritative guidelines to govern practice. ASPMN Annual Meeting, 2009 Jacksonville, Florida 12