2 17 16 Opioid Syllabus
2016-02-17
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2/9/2016 DISCLOSURES • Hassan R. Mir, MD, MBA, FACS • Medical/Orthopaedic Publications Editorial/Governing Board • • • • • OTA Newsletter Editor OsteoSynthesis, The JOT Online Discussion Forum Editor JOT Associate Editor JAAOS Consultant Reviewer JBJS Consultant Reviewer • Board Member/Committee Appointments for a Society • AAOS Diversity Advisory Board and Council on Advocacy Member • OTA Public Relations Committee • FOT Nominating and Membership Committees • Speakers Bureau/Paid Presentations for a Company or Supplier • Depuy-Synthes • Paid Consultant for a Company or Supplier • Smith & Nephew 1 2/9/2016 Opioid Epidemic •Americans <5% of World Population •99% of Global Hydrocodone Supply •80% of Global Opioid Supply •Prescription Opioid Overdose Deaths Tripled in Last Decade Manchikanti L, Singh Angelie. Therpeutic Opioids: a ten-year perspective on the complexities and complications of the escalating use, abuse, and nonmedical use of Opioids. Pain Physician. 2008;11:S63-S88. CDC Press Release. Prescription painkiller overdoses at epidemic levels. Annual Deaths Opioids > Cocaine + Heroin Opioids > Suicide or MVC 2 2/9/2016 Source of Opioids? Substance Abuse and Mental Health Services Administration (2007). Results from the 2006 National Survey on Drug Use and Health: National Findings. (Office of Applied Studies, NSDUH Series H-32, DHHS Publication No. SMA 07-4293). Rockville, MD. www.oas.samh sa.gov/nsduh/2k6nsduh/2k6results.pdf States Requiring PDMP Use Kentucky Massachusetts New Mexico New York Ohio Tennessee West Virginia 3 2/9/2016 Role of Orthopaedic Surgeons? Orthopedic Surgeons are the 3rd Highest Prescribers of Opioids (7.7% of all Rx) PCPs – 28.8%; Internists – 14.6% Orthopedic Surgery & Opioids • Literature on Worse Clinical Outcomes in: • Trauma • Low Back Pain • Occupational MSK Disorders • TKA • Reverse Shoulder Arthroplasty • Spine Surgery • More coming… 4 2/9/2016 Orthopaedic Trauma Patients using Opioids Preoperatively? Doctor Shopping Postoperatively? Doctor Shopping • Prevalence: 21% Increased: – Postop Opioid Rx – Duration of Postop Opioid Use – MED per day 5 2/9/2016 Rx •Single Opioid Provider: –2 Rx’s –Duration of 28 days –26 MED/day (mg) •Multiple Opioid Providers: –7 Rx’s –Duration of 110 days –43 MED/day (mg) Doctor Shopping Predictors •≤High School Education (3.2 X) •Preoperative Opioid Use (4.5 X) Recommendations • Monitor Postoperative Opioid Rx following Orthopaedic Trauma • Identify and Prevent Doctor Shopping • • CSMD Utilization Particularly for Patients with: • • Lower Level of Education History of Preoperative Opioid Use 6 2/9/2016 Patient Expectations 7 2/9/2016 8 2/9/2016 Provider Education Provider Education 9 2/9/2016 Pain Clinics • Rapid Rise in Number • 732 in FL • 4 Pain Clinics for every 100,000 People • Outnumber McDonald’s • Some Pain Clinics provide Important Services for Patient Care and Pain Management • However, “Pill Mills” Prescribe and Dispense Controlled Substances Outside the Scope of Standard Medical Practice PDMPs • Programs with Positive Early Results Conclusions • The US is in an Opioid Epidemic • Detrimental Effects on Individuals and Society • Our Patients are At-Risk • Orthopaedic Surgeons should: • • • • Recognize Risk Factors Set Patient Expectations and Prescribe Responsibly Take Control of MSK Pain Management Educate Other Providers 10 2/9/2016 THANK YOU Hassan R. Mir, MD, MBA, FACS 11 2/15/2016 Intravenous (IV) Acetaminophen Effectiveness in Pain Management of the Geriatric Hip Fracture Patient Clifford B. Jones, MD FACS The CORE Institute Banner University Medical Center University of Arizona Orthopaedic Residency Program Phoenix AZ Is Scheduled Intravenous Acetaminophen Effective in the Pain Management Protocol of Geriatric Hip Fractures? Alexander J. Bollinger, M.D. 1,2 Paul D. Butler, M.D. 1,2 Matthew S. Nies, M.D. 2 Debra L. Sietsema, PhD. 2,3 Clifford B. Jones, M.D. 2,3 Terrence J. Endres, M.D. 2,3 American Academy of Orthopaedic Surgeons, Annual Meeting March 24, 2015 1. Grand Rapids Medical Education Partners 2. Michigan State University CHM 3. Orthopaedic Associates of Michigan Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):202-8. doi: 10.1177/2151458515588560. 1 2/15/2016 Purpose • Hip fractures are a common problem in the geriatric population, having substantial impact on the healthcare system • • $30 billion annual cost 1-2 Often result in functional decline and greater mortality 2-9 Purpose - con’t • Post-operative pain control remains difficult in the elderly population • Opioid- and NSAID-associated complications more common 2,10-22 • Intravenous acetaminophen has been shown in prior studies to be safe and efficacious in major orthopaedic surgery 20,22-29 What is IV Tylenol • • • • • OFIRMEV® (acetaminophen) injection Mallinckrodt Pharmaceuticals Administration 650mg q 4 or 1000mg q 6 70% Higher peak 15-30 min dose 50% Lower hepatic levels 2 2/15/2016 Mean Plasma & CSF Concentrations of IV, PO, & PR Acetaminophen IV, PO, PR Costs $ 3 2/15/2016 Hypothesis • The use of scheduled IV acetaminophen as part of a perioperative pain-control protocol for patients 65 or older with hip fractures will reduce problems associated with inadequate pain control, while simultaneously decreasing complications associated with opioid analgesic use and reducing length of hospital stay. • Start on admission • Complete POD #2 Methods • Retrospective chart review from June 1, 2011 May 31, 2013 • Group 1: June 1, 2011 - May 31, 2012 » • (before initiation of protocol) Group 2: June 1, 2012 - May 31, 2013 » (after initiation of protocol) Methods - con’t • Inclusion Criteria: • 65 years or older • Admitted to orthopaedic surgery service • Underwent operative fixation of “hip” fracture by one of six surgeons within specified time period • CPT codes 27235, 27236, 27244, 27245 • AO classification 31-A & 31-B 4 2/15/2016 Methods - con’t – Exclusion Criteria: • Pathologic fracture • Periprosthetic fracture • Concomitant orthopaedic injury requiring operative intervention • Perioperative death (same hospitalization) Methods - con't Total Fractures Group 1 Group 2 Geriatric Fractures 433 214 219 Subtrochanteric 13 7 6 Non-Ortho Admit 55 24 31 Included Hip Fractures 365 183 182 Concomitant Injuries 8 3 5 Periprosthetic 8 5 3 Pathologic 8 4 4 Perioperative Death 5 2 3 336 169 167 Exclusions: Total 284 subjects required (142 per cohort) at α=0.05 and β=0.20 Methods - con’t • Statistical Analysis • Quantitative data were analyzed using the unpaired t-test, while nominal data were analyzed using the chi-square test • Multivariate regression analyses for quantitative data and logistic regression analysis for nominal data • Significance evaluated at p<0.05 5 2/15/2016 Study Population Age (years)* Group 1 (n=169) Group 2 (n=167) p-Value 83.3 (65-101) 81.8 (66-101) 0.08 Gender (number of patients) 0.85 Male 45 (27%) 46 (28%) Female 124 (73%) 121 (72%) Femoral Neck 81 (48%) 78 (47%) Intertrochanteric 88 (52%) 89 (53%) Arthroplasty 71 (42%) 68 (41%) Internal Fixation 98 (58%) 99 (59%) Fracture (number of patients) 0.33 Surgical Treatment 0.81 25.3 (13.4-57.1) 26.3 (16.1-41.5) 0.10 Time from Admission to OR (hours)* 17.1 (1-65) 15.3 (0-56) 0.09 Total Acetaminophen (# doses)* 8.7 (0-35) 9.2 (0-30) 0.48 Oral Acetaminophen (# doses)* 8.5 (0-35) 5.4 (0-27) <0.001 IV Acetaminophen (# doses)* 0.2 (0-12) 3.7 (0-12) <0.001 Body Mass Index* *Mean (Range) Results Group 1 (n=169) Group 2 (n=167) Length of Stay (days) Mean (Range) 3.8 (1.5-11.4) 41.3 (0-189.7) 28.3 (0-204.3) 9.6 (0-49.9) 7.8 (0-53.2) 1.0 (0-10) 0.8 (0-4) 0.8 (0-11) 0.7 (0-7) Narcotic Use (mg morphine-equivalent) Mean (Range) <0.001 Daily Narcotic Use (mg/day) Mean (Range) 0.05 Bowel Motility Agents (# doses) Mean (Range) 0.29 Anti-emetic Agents (# doses) Mean (Range) 0.48 Pain Score (VAS scale) Mean (Range) <0.001 4.2 (0-9.2) 2.8 (0-7.7) 21.8 (0-66.7) 10.4 (0-100) Missed PT sessions (%) Mean (Range) <0.001 Discharge Location (# patients) Home Secondary Care Facility p-Value <0.001 4.4 (1.2-13) 0.001 12 (7%) 32 (19%) 157 (93%) 135 (81%) Results - con’t 6 2/15/2016 Results - con’t Results - con’t Results - con’t 7 2/15/2016 Results - con’t Results - con’t Results - con’t Intravenous acetaminophen usage both correlated with and was independently predictive of: • shorter mean length of hospital stay • lower mean narcotic usage • lower mean pain score • lower percentage of physical therapy sessions missed • higher likelihood of discharge to home 8 2/15/2016 Conclusion • The utilization of scheduled IV acetaminophen as part of a standardized pain-management protocol for geriatric hip fractures resulted in a shortened length of hospital stay, decreased pain score and narcotic use, fewer missed physical therapy sessions, and higher rate of discharge to home. Future Directions? • Cost-analysis • OFIRMEV® ~$40 per 1000 mg dose • Prospective, randomized trials • Verified outcome measures References 1.Hall MJ, DeFrances CJ, Williams SN, et al. National Hospital Discharge Survey: 2007 summary. Natl Health Stat Report. 2010;(29):1-20, 24. 2.Marks R, Allegrante J, Ronald-MacKenzie C, et al. Hip fractures among the elderly: causes, consequences and control. Ageing Research Reviews. 2003;2:57-93. 3.Leibson C, Tosteson A, Gabriel S, et al. Mortality, disability, and nursing home use for persons with and without hip fractur e: a population-based study. Journal of the American Geriatrics Society. 2002;50:1644-1650. 4.Brainsky A, Glick H, Lydick E, et al. The economic cost of hip fractures in community-dwelling older adults: a prospective study. J Am Geriatr Soc. 1997;45:281-287. 5.Hannan EL, Magaziner J, Wang JJ, et al. Mortality and locomotion 6 months after hospitalization for hip fracture: risk factor s and risk-adjusted hospital outcomes. JAMA. 2001;285:2736-2742. 6.Alegre-Lopez J, Cordero-Guevara J, Alonso-Valdivielso JL, et al. Factors associated with mortality and functional disability after hip fracture: an inception cohort study. Osteoporos Int. 2005;16:729-736. 7.Cooper C, Cole ZA, Holroyd CR, et al. Secular trends in the incidence of hip and other osteoporotic fractures. Osteoporos Int. 2011;22:1277-1288. 8.Hayes W, Myers E, Robinovitch S, et al. Etiology and prevention of age-related hip fractures. Bone. 1996;18:77-86. 9.Schneider E, Guralnik J. The aging of America: Impact on health care costs. JAMA : the journal of the American Medical Association. 1990;263:2335-2340. 10.Morrison RS, Magaziner J, McLaughlin MA, et al. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003;103:303-311. 11.Pasero CL, McCaffery M. Reluctance to order opioids in elders. Am J Nurs. 1997;97:20, 23. 12.Duggleby W, Lander J. Cognitive status and postoperative pain: older adults. J Pain Symptom Manage. 1994;9:19-27. 13.Gustafson Y, Berggren D, Brannstrom B, et al. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988;36:525-530. 14.Givens JL, Sanft TB, Marcantonio ER. Functional recovery after hip fracture: the combined effects of depressive symptoms, cognitive impairment, and delirium. J Am Geriatr Soc. 2008;56:1075-1079. 15.Marcantonio ER, Flacker JM, Michaels M, et al. Delirium is independently associated with poor functional recovery after hip fracture. J Am Geriatr Soc. 2000;48:618-624. 9 2/15/2016 References 16. Lane JM. CORR Insights (R): Does early functional outcome predict 1-year mortality in elderly patients with hip fracture? Clin Orthop Relat Res. 2013;471:2711-013-2995-6. Epub 2013 Apr 19. 17.Koval KJ, Skovron ML, Aharonoff GB, et al. Ambulatory ability after hip fracture. A prospective study in geriatric patients. Clin Orthop Relat Res. 1995;(310):150-159. 18.Bernabei R, Gambassi G, Lapane K, et al. Management of pain in elderly patients with cancer. SAGE Study Group. Systematic Assessment of Geriatric Drug Use via Epidemiology. JAMA : the journal of the American Medical Association. 1998;279:1877-1882. 19.Cheville A, Chen A, Oster G, et al. A randomized trial of controlled-release oxycodone during inpatient rehabilitation following unilateral total knee arthroplasty. J Bone Joint Surg Am. 2001;83-A:572-576. 20.Koppert W, Frotsch K, Huzurudin N, et al. The effects of paracetamol and parecoxib on kidney function in elderly patients undergoing orthopedic surgery. Anesth Analg. 2006;103:1170-1176. 21.Jahr JS, Breitmeyer JB, Pan C, et al. Safety and efficacy of intravenous acetaminophen in the elderly after major orthoped ic surgery: subset data analysis from 3, randomized, placebocontrolled trials. Am J Ther. 2012;19:66-75. 22.Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011;12:961-981. 23.van der Westhuizen J, Kuo PY, Reed PW, et al. Randomised controlled trial comparing oral and intravenous paracetamol (acetaminophen) plasma levels when given as preoperative analgesia. Anaesth Intensive Care. 2011;39:242-246. 24.Sinatra RS, Jahr JS, Reynolds LW, et al. Efficacy and safety of single and repeated administration of 1 gram intravenous a cetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831. 25.Lachiewicz PF. The role of intravenous acetaminophen in multimodal pain protocols for perioperative orthopedic patients. O rthopedics. 2013;36:15-19. 26.Looke TD, Kluth CT. Effect of preoperative intravenous methocarbamol and intravenous acetaminophen on opioid use after primary total hip and knee replacement. Orthopedics. 2013;36:25-32. 27.Sinatra RS, Jahr JS, Reynolds L, et al. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded ana lysis. Pain Pract. 2012;12:357-365. 28.Tsang KS, Page J, Mackenney P. Can intravenous paracetamol reduce opioid use in preoperative hip fracture patients? Orthop edics. 2013;36:20-24. 29.Abdulla S, Eckhardt R, Netter U, et al. Efficacy of three IV non-opioid-analgesics on opioid consumption for postoperative pain relief after total thyroidectomy: a randomised, double-blind trial. Middle East J Anesthesiol. 2012;21:543-552. Thank You 10 2/15/2016 Pain Strategies for Practicing Orthopaedic Surgeons Joseph R. Hsu, MD Professor, Orthopaedic Trauma Limb Lengthening and Deformity Service Carolinas Medical Center Disclosures CDC funding Prescription Reporting with Immediate Medication Utilization Mapping (PRIMUM) Smith & Nephew – speakers bureau Acumed – consulting Slide contributions from Michael Ruffolo, Steven Olson, and Alejandro Marquez-Lara BLUF: Multi-modal strategy Short acting opioids 8 weeks maximum NSAIDs Non-selective: Selective if GI risk: Refer to pain management if requiring more narcotics Ibuprofen, naproxen, etc. Meloxicam (generic) Gabapentin Up to 1800 mg/day effective Increased evening dose “Primum non nocere” No sustained-release opioids No sedative-hypnotics Benzos, ambien, etc. 1 2/15/2016 Did he say NSAIDS??? What should you fear? Geusens P, Emans PJ, de Jong JJ, van den Bergh J. NSAIDs and fracture healing. Curr Opin Rheumatol. 2013 Jul;25(4):524-31. Ortho influence on pain management Walter Crawford Kelly, Jr. (August 25, 1913 – October 18, 1973) 2 2/15/2016 Secondary Bone Healing Schindeler et al, Stem Cell Dev Biology, 2008 PG Inflammation Vasodilation “4Rs” Chondrocyte Activity Osteoblast Activity Angiogenesis Secondary Bone Healing Models Control Rofecoxib Simon AM., et al., JBMR, 2002 3 2/15/2016 Primary Bone Healing Models Martins MV., et al., Braz Dent J, 2005 Sato S., et al., J. Pharmacology, 1986 NSAIDs do not appear to have a significant effect on primary bone healing Significant flaws in clinical studies condemning NSAIDS Burd TA, Hughes MS, Anglen JO. Heterotopic ossification prophylaxis with indomethacin increases the risk of long-bone nonunion. J Bone Joint Surg (Br) 2003;85(5):700-5. Dodwell ER, Latorre JG, Parisini E, Zwettler E, Chandra D, Mulpuri K, et al. NSAID exposure and risk of nonunion: a meta-analysis of case-control and cohort studies. Calcif Tissue Int 2010;87:193-202. Bhattacharyya T, Levin R, Vrahas MS, Solomon DH. Nonsteroidal antiinflammatory drugs and nonunion of humeral shaft fractures. Arthritis Rheum 2005;53:364-7. Jeffcoach DR, Sams VG, Lawson CM, Enderson BL, Smith ST, Kline H, et al. Nonsteroidal anti-inflammatory drugs’ impact on nonunion and infection rates in long-bone fractures. J Trauma Acute Care Surg 2014;76:779-83. Giannoudis PV, MacDonald DA, Matthews SJ, Smith RM, Furlong AJ, De Boer P. Nonunion of the femoral diaphysis. The influence of reaming and non-steroidal antiinflammatory drugs. J Bone Joint Surg (Br) 2002;82(5):655-8. 4 2/15/2016 JBJS Br, 2000 32 Nonunions of Femoral Diaphysis vs 67 Comparable patients Case-Control Sample size Patient recall phone or clinic NSAID Use NSAID use cause or result of nonunion? 62.5% vs 13.4% 22 vs 1 week use RR = 10.74 Many different techniques: Different nails, reamed and unreamed. Slide from Michael Ruffalo, MD J Trauma Acute Care Surg, 2014 Retrospective CaseControl of all femur, tibia, humerus fractures 1,901 Patients 12.1% Received NSAIDS (short term in hospital) NSAIDS No mention of NSAID use out of hospital No discussion of fracture characteristics Best Trauma Center in America? 17% of patients receiving NSAIDS had a complication OR = 2.17 p < 0.016 <1% infection in open fractures 3.2% Infection, Malunion/Nonunion Rate Slide from Michael Ruffalo, MD Levels of evidence 5 Number of Clinical Studies Cited 0 Avoid NSAIDs NSAIDs Ok Radi Mean: 8.0 Barry 12 Harder Pountos_08 Cottrell Abdul-Hadi 8 Badolier Gajraj Bailey Xian Pountos_12 Geusens Dodwell Li Kurmis 10 Boursinos Vuolteenaho Wheeler Dahners Gaston Thaller Dumont 6 Ziltener van Esch 2/15/2016 Literature Reviews Adult Studies Pediatric Studies Mean: 4.0 Mean: 2.0 4 2 No clear recommendations 6 2/15/2016 Geusens et al Metabolic Bone Disease 2013 General Review Pountous et al World J of Surg 2012 The prospective series show less adverse effects 7 2/15/2016 Overall Meta-Analysis • Dodwell et al Calcif Tissue Int 2010 Higher Quality Studies • Dodwell et al Calcif Tissue Int 2010 Higher Dose Ketorolac • Dodwell et al Calcif Tissue Int 2010 8 2/15/2016 Evidence Based Review The balance of evidence … appears to suggest that a short-duration NSAID regimen is a safe and effective supplement to other modes of postfracture pain control, without a significantly increased risk of sequelae related to disrupted healing Non-selective NSAIDs Less effect on bone healing Selective still helpful with side-effects of NSAIDs Gerstenfeld LC, Thiede M, Seibert K, Mielke C, Phippard D, Svagr B, Cullinane D, Einhorn TA. Differential inhibition of fracture healing by non-selective and cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs. J Orthop Res. 2003 Jul;21(4):670-5. Are we OK with Opioid Monotherapy being the standard for musculoskeltal pain? Primarily US Past 15 to 20 years Industry driven Multi-billion dollar industry JCAHO/Joint Commission 9 2/15/2016 Wake Forest Baptist Medical Center Fraudulent Marketing: OxyContin “with the intent to defraud or mislead,” it marketed and promoted OxyContin as a drug that was less addictive, less subject to abuse and less likely to cause other narcotic side effects than other pain medications. United States Attorney’s Office Western District of Virginia [news release]. Available at: http://www.dodig.osd.mil/ IGInformation/IGInformationReleases/ prudue_frederick_1.pdf. Accessed September 11, 2008. 10 2/15/2016 Efficacy no better Hale ME, Fleischmann R, Salzman R, et al. Efficacy and safety of controlledrelease versus immediate-release oxycodone: randomized, double-blind evaluation in chronic back pain. Clin J Pain. 1999;15:179–183. Kaplan R, Parris WC, Citron MI, et al. Comparison of controlled-release and immediaterelease oxycodone in cancer pain. J Clin Oncol. 1998;16:3230–3237. Staumbaugh JE, Reder RF, Stambaugh MD, et al. Double-blind, randomized comparison of the analgesic and pharmacokinetic profiles of controlledand immediate-release oral oxycodone in cancer pain patients. J Clin Pharmacol. 2001;41:500–506. Heiskanen T, Kalso E. Controlled-release oxycodone and morphine in cancer related pain. Pain. 1997;73:37–45. Mucci-LoRusso P, Berman BS, Silberstein PT, et al. Controlled-release oxycodone compared with controlledrelease morphine in treatment of cancer pain: a randomized, double-blind, parallel-group study. Eur J Pain. 1998; 2:239–249. Bruera E, Belzile M, Pituskin E, et al. Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled- release morphine in patients with cancer pain. J Clin Oncol. 1998;16: 3222–3229. Big business Significant payments to pain KOLs, pain societies, and pain advocacy groups UW Pain & Policy Studies Group $2.5 million paid by opioid manufacturers http://hcrenewal.blogspot.com/2012/12/the-king-of-pain-recants-pharmaceutical.html http://www.jsonline.com/watchdog/watchdogreports/119130114.html 11 2/15/2016 Pain Management: Opioid monotherapy vs. multimodal Opioid monotherapy Short acting alone Short and long acting Multi-modal Short course, shortacting opioids NSAIDS Gabapentin What is the evidence behind opioids for NCP? 12 2/15/2016 Moderate improvements pain & physical function vs. placebo Comparable to NSAIDs or TCAs 30% adverse events 25% discontinued Disclaimer: most studies industry funded… Only short term studies Nausea, dizziness Disclaimer: most studies industry funded… Only short term studies No difference funtional outcome 13 2/15/2016 What about Chronic Non Cancer Pain (CNCP)? persons in chronic pain on opioids reported decreased pain relief, functional capacity, and quality of life vs persons in chronic pain not on opioids, adjusting for severity Opposite marketing claims Eriksen J, Sjogren P, Bruera E, Ekholm O, Rasmussen NK. Critical issues on opioids in chronic non-cancer pain: an epidemiological study. Pain 2006;125:172–179 Are higher doses better? Liberally escalating dosage vs. “hold the line” dosage No significant improvement primary pain and functional outcome escalating 27% overall discharged from trial (misuse/noncompliance) Naliboff BD, Wu SM, Schieffer B, et al. A randomized trial of 2 prescription strategies for opioid treatment of chronic nonmalignant pain. J Pain 2011;12:288–296. Functional rehab Yes – taking opioids No – not taking Work return and retention inverse to dose 14 2/15/2016 All 20 tablets of naproxen 500mg BID Randomized (PRN LBP) Placebo Cyclobenzaprine 5mg Oxycodone 5/325 No difference pain improvement 1 week or 3mos More adverse events Surgery always needs opioids, right? Patient satisfaction: Cultural? Prospective, observational USA vs. Netherlands Very few opioids in Netherlands 15 2/15/2016 What about Satisfaction Scores? Higher opioid doses post-op Greater reported pain Decreased satisfaction with pain relief Chen L, Vo T, Seefeld L, Malarick C, Houghton M, Ahmed S, Zhang Y, Cohen A, Retamozo C, St Hilaire K, Zhang V, Mao J. Lack of correlation between opioid dose adjustment and pain score change in a group of chronic pain patients. J Pain. 2013; 14:384–392. Trevino CM, deRoon-Cassini T, Brasel K. Does opiate use in traumatically injured individuals worsen pain and psychological outcomes? J Pain. 2013;14:424–430. Gabapentin Neuropathic component Complex pain management Previous opioid use High dose requirements Ho KY, Gan TJ, Habib AS. Gabapentin and postoperative pain--a systematic review of randomized controlled trials. Pain. 2006 Dec 15;126(1-3):91-101. 16 2/15/2016 Gabapentin CRPS Mellick GA, Mellicy LB, Mellick LB: Letter: Gabapentin in the management of reflex sympathetic dystrophy. J Pain Symptom Manage 1995;10:265-266. Long term doses up to 2400mg/day Short term doses up to 3600mg/day Acute pain Werner MU, Perkins FM, Holte K, Pedersen JL, Kehlet H: Effects of gabapentin in acute inflammatory pain in humans. Reg Anesth Pain Med 2001;26:322-328. Neuropathic pain Moore RA, Wiffen PJ, Derry S, Toelle T, Rice AS. Gabapentin for chronic neuropathic pain and fibromyalgia in adults. Cochrane Database Syst Rev. 2014 Apr 27;4:CD007938. Gabapentin for Adults with Neuropathic Pain: A Review of the Clinical Efficacy and Safety [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Apr 14. NSAIDs Clinical Scenarios Contraindications Renal insufficiency Allergy Peptic Ulcer Disease 17 2/15/2016 Clinical Scenarios ED management Non-operative Operative Peri-operative Outpatient Special cases Nonunion Osteotomy Bone transport Emergency Department 26 y.o. male Cost effective? Rainer TH, Jacobs P, Ng YC, Cheung NK, Tam M, Lam PK, Wong R, Cocks RA. Cost effectiveness analysis of intravenous ketorolac and morphine for treating pain after limb injury: double blind randomised controlled trial. BMJ. 2000 Nov 18;321(7271):1247-51. 18 2/15/2016 Non-operative injuries Craig M, Jeavons R, Probert J, Benger J. Randomised comparison of intravenous paracetamol and intravenous morphine for acute traumatic limb pain in the emergency department. Emerg Med J. 2012 Jan;29(1):37-9. Davis TRC, Ackroyd CE. Non-steroidal anti-inflammatories in the treatment of Colles’ fractures. Br J Clin Pract 1988;42(5):184-9. Healed, good function, pain free Operative 19 2/15/2016 NSAIDs work after surgery Kang H, Ha YC, Kim JY, Woo YC, Lee JS, Jang EC. Effectiveness of multimodal pain management after bipolar hemiarthroplasty for hip fracture: a randomized, controlled study. J Bone Joint Surg Am. 2013 Feb 20;95(4):291-6. Maheshwari AV, Boutary M, Yun AG, Sirianni LE, Dorr LD. Multimodal analgesia without routine parenteral narcotics for total hip arthroplasty. Clin Orthop Relat Res. 2006 Dec;453:231-8. Norman PH, Daley MD, Lindsey RW. Preemptive analgesic effects of ketorolac in ankle fracture surgery. Anesthesiology. 2001 Apr;94(4):599-603. Derry CJ, Derry S, Moore RA, McQuay HJ. Single dose oral ibuprofen for acute postoperative pain in adults. Cochrane Database Syst Rev 2009;(3):CD001548. Ketorolac (Toradol) IV Ketorolac trometamol: as effective as morphine for surgical pain and pain related to cancer, and it has fewer side effects. Gillis JC, Brogden RN. Ketorolac. A reappraisal of its pharmacodynamic and pharmacokinetic properties and therapeutic use in pain manage ment. Drugs 1997;53:13988. GI haemorrhage risk only slightly higher with ketorolac than morphine (odds ratio 1.17 (95% CIs 0.991.13)); risk rises sharply more than five days or in patients older than 75 Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, et al. Parenteral ketorolac and risk of gastrointestinal and operative site bleed ing. A postmarketing surveillance study. JAMA 1996;275:37682. 20 2/15/2016 20 yo contiguous neck, trochanteric, & subtroch Operative injuries Cultural expectations Equivalent or better outcomes NSAIDs Hip, ankle, and femur fractures Lindenhovius AL, Helmerhorst GT, Schnellen AC, Vrahas M, Ring D, Kloen P. Differences in prescription of narcotic pain medication after operative treatment of hip and ankle fractures in the United States and The Netherlands. J Trauma. 2009 Jul;67(1):160-4. Helmerhorst GT, Lindenhovius AL, VrahasM, Ring D, Kloen P. Satisfaction with pain relief after operative treatment of an ankle fracture. Injury. 2012 Nov;43(11):1958-61. Carragee EJ, Vittum D, Truong TP, Burton D. Pain control and cultural norms and expectations after closed femoral shaft fractures. Am J Orthop (Belle Mead NJ). 1999;28:97–102. Peri-operative 21 2/15/2016 Ketorolac Short acting opioids plus NSAIDs Own our influence on pain management Walter Crawford Kelly, Jr. (August 25, 1913 – October 18, 1973) 22 2/15/2016 Martin BC, Fan MY, Edlund MJ, Devries A, Braden JB, Sullivan MD. Long-term chronic opioid therapy discontinuation rates from the TROUP study. J Gen Intern Med 2011;26:1450–1457. Instead of this reaction to NSAIDS… Weigh the facts NSAIDs and delayed bone healing Clinical Association ≠ causation Conflicting basic science Opioids and delayed bone healing Clinical Association ≠ causation Some evidence in basic science Opioids and dependence Opioids and death Causation clear Causation clear 23 2/15/2016 2/15/2016 70 Prescription Reporting with Immediate Medication Utilization Mapping (PRIMUM) Principal Investigators: Rachel Seymour, PhD, and Joseph Hsu, MD Co-investigators: Michael Beuhler, MD; Michael Bosse, MD; Stephen Colucciello, MD; Michael Gibbs, MD; Steven Jarrett, PharmD; Michael Runyon, MD; Animita Saha, MD; Brad Watling, MD; Christopher Griggs, MD; Stephen Wyatt, DO; Daniel Leas, MD; Sharon Schiro, PhD; Meghan Wally, MSPH • Goals: 1) To identify patients at high risk for misuse, abuse, and diversion of prescription opioids and benzodiazepines. 2) To provide critical information to the prescriber at the point of care in order to inform clinical decision-making 2/15/2016 71 Intervention: Alert System • Prescriber selects controlled substance • EMR searches patient chart for defined risk factors for abuse/misuse/diversion • Provides prescriber with alert • Prescriber can continue or discontinue script. 2/15/2016 72 24 2/15/2016 2/15/2016 73 What can be done? Become conversant in the problem Stop prescribing long acting Multi-modal pain management Local policy Utilize PDMP or implement decision support 25 2/15/2016 Useful Tools and Tips on Opioids Difficult discussion Frame as patient safety Enroll reasonable family member If available Consistent policies and procedures Blame the policy Assess sedation: Pasero scale Assess risk with MME Calculator 26 2/15/2016 CDC Guidelines 12 guidelines, 56 pages chronic pain (i.e., pain lasting >3 months or past the time of normal tissue healing) http://www.cdc.gov/drugoverdose/prescribing/guideline.html New trend? Blame the courts “Low T” Healing, bone mineral density, erectile dysfunction, libido, etc. De Maddalena C, Bellini M, Berra M, Meriggiola MC, Aloisi AM. Opioid-induced hypogonadism: why and how to treat it. Pain Physician. 2012 Jul;15(3 Suppl):ES111-8. Aloisi AM, Ceccarelli I, Carlucci M, Suman A, Sindaco G, Mameli S, Paci V, Ravaioli L, Passavanti G, Bachiocco V, Pari G. Hormone replacement therapy in morphine-induced hypogonadic male chronic pain patients. Reprod Biol Endocrinol. 2011 Feb 18;9:26. Birthi P, Nagar VR, Nickerson R, Sloan PA. Hypogonadism associated with long-term opioid therapy: A systematic review. J Opioid Manag. 2015 May-Jun;11(3):255-78. Rubinstein A, Carpenter DM. Elucidating risk factors for androgen deficiency associated with daily opioid use. Am J Med. 2014 Dec;127(12):1195-201. doi: 10.1016/j.amjmed.2014.07.015. Epub 2014 Jul 22. Demarest SP, Gill RS, Adler RA. Opioid endocrinopathy. Endocr Pract. 2015 Feb 1;21(2):190-8. 27 2/15/2016 Multi-modal strategy Short acting opioids 8 weeks maximum NSAIDs Non-selective: Selective if GI risk: Refer to pain management if requiring more narcotics Ibuprofen, naproxen, etc. Meloxicam (generic) Gabapentin Up to 1800 mg/day effective Increased evening dose “Primum non nocere” No sustained-release opioids No sedative-hypnotics Benzos, ambien, etc. Thank you Discussion 2/15/2016 84 28
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