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Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery

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Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery Neuromodulation: Technology at the Neural Interface Received: December 12, 2011 Revised: April 4, 2012 Accepted: May 16, 2012 (onlinelibrary.wiley.com) DOI: 10.1111/j.1525-1403.2012.00476.x Polyanalgesic Consensus Conference 2012: Recommendations for the Management of Pain by Intrathecal (Intraspinal) Drug Delivery: Report of an Interdisciplinary Expert Panel Timothy R. Deer, MD1, Joshua Prager, MD2, Robert Levy, MD, PhD3, James Rathmell, MD4, Eric Buchser, MD5, Allen Burton, MD6, David Caraway, MD, PhD7, Michael Cousins, MD8, José De Andrés, MD, PhD9, Sudhir Diwan, MD10, Michael Erdek, MD11, Eric Grigsby, MD12, Marc Huntoon, MD, PhD13, Marilyn S. Jacobs, PhD2, Philip Kim, MD14, Krishna Kumar, MD15, Michael Leong, MD16, Liong Liem, MD17, Gladstone C. McDowell II, MD18, Sunil Panchal, MD19, Richard Rauck, MD20, Michael Saulino, MD, PhD21, B. Todd Sitzman, MD, MPH22, Peter Staats, MD23, Michael Stanton-Hicks, MD, PhD24, Lisa Stearns, MD25, Mark Wallace, MD26, K. Dean Willis, MD27, William Witt, MD28, Tony Yaksh, PhD26, Nagy Mekhail, MD, PhD24 Address correspondence to: Timothy Deer, MD, Center for Pain Relief, 400 Court Street, Suite 100, Charleston, WV 25301, USA. Email: [email protected] 1 Center for Pain Relief, Charleston, WV, USA; 2 University of California—Los Angeles, Los Angeles, CA, USA; 3 University of Florida, Jacksonville, FL, USA; 4 Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; 5 Anaesthesia and Pain Management Department, EHC-Hospital, Morges and CHUV University Hospital, Lausanne, Switzerland; 6 Houston Pain Associates, LLC, Houston, TX, USA; 7 Center for Pain Relief, Tri-State, LLC, Huntington, WV, USA; 8 Kolling Institute of Medical Research at the Royal North Shore Hospital Sydney, NSW, Australia; 9 Valencia University School of Medicine and General University Hospital, Valencia, Spain; 10 SUNY Downstate Medical Center, Staten Island, University Hospital, New York, NY, USA; 11 Departments of Anesthesiology, Critical Care Medicine and Oncology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; 12 Napa Pain Institute, and Neurovations Clinical Research and Education, Napa, CA, USA; 13 Vanderbilt University, Nashville, TN, USA; 14 Christiana Hospital, Newark, DE, USA and Bryn Mawr Hospital, Bryn Mawr, PA, USA; 15 University of Saskatchewan, Regina, SK, Canada; 16 Stanford University, Palo Alto, CA, USA; 17 St. Antonius Hospital, Nieuwegein, The Netherlands; 18 Integrated Pain Solutions, Columbus, OH, USA; 19 National Institute of Pain, Lutz, FL, USA; 20 Carolinas Pain Institute and Wake Forest University School of Medicine Baptist Health, Winston-Salem, NC, USA; 21 MossRehab and Department of Rehabilitation Medicine, Jefferson Medical College, Philadelphia, PA, USA; 22 Advanced Pain Therapy, PLLC, Hattiesburg, MS, USA; 23 Premier Pain Management Centers, Shrewsbury, NJ, USA and Johns Hopkins University, Baltimore, MD, USA; 24 Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA; 25 Center for Pain and Supportive Care, Phoenix, AZ, USA; 26 University of California—San Diego, La Jolla, CA, USA; 27 Alabama Pain Center, Huntsville, AL, USA and University of Alabama School of Nursing, Birmingham, AL, USA; and 28 University of Kentucky—Lexington, Lexington, KY, USA (Emeritus Professor) For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http:// 436 www.wiley.com/bw/submit.asp?ref=1094-7159&site=1 Sources of financial support: This project was supported by grants from Medtronic, Inc. (Minneapolis, Minnesota, USA) and Azur Pharma Ltd (Dublin, Ireland). www.neuromodulationjournal.com © 2012 International Neuromodulation Society Neuromodulation 2012; 15: 436–466 INTRATHECAL THERAPY CONSENSUS Introduction: The use of intrathecal (IT) infusion of analgesic medications to treat patients with chronic refractory pain has increased since its inception in the 1980s, and the need for clinical research in IT therapy is ongoing. The Polyanalgesic Consensus Conference (PACC) panel of experts convened in 2000, 2003, and 2007 to make recommendations on the rational use of IT analgesics based on preclinical and clinical literature and clinical experiences. Methods: The PACC panel convened again in 2011 to update the standard of care for IT therapies to reflect current knowledge gleaned from literature and clinical experience. A thorough literature search was performed, and information from this search was provided to panel members. Analysis of published literature was coupled with the clinical experience of panel members to form recommendations regarding the use of IT analgesics to treat chronic pain. Results: After a review of literature published from 2007 to 2011 and discussions of clinical experience, the panel created updated algorithms for the rational use of IT medications for the treatment of neuropathic pain and nociceptive pain. Conclusions: The advent of new algorithmic tracks for neuropathic and nociceptive pain is an important step in improving patient care. The panel encourages continued research and development, including the development of new drugs, devices, and safety recommendations to improve the care of patients with chronic pain. Keywords: Chronic pain, consensus, intrathecal Conflict of Interest: Timothy R. Deer, MD: consulting (Medtronic, Spinal Modulation, St. Jude, Medasys, Bioness, Vertos). Robert Levy, MD, PhD: consulting (Medtronic and Codman & Shurtleff). Joshua Prager, MD: honoraria (Medtronic, Eli Lily, Qutenza). Allen Burton, MD: consulting (Medtronic, BSCIS, Stryker), speaking (Azur, Cadence, Cephalon, NeurogesX, Pricara, Pfizer), stockholder (Vapogenix). Eric Buchser, MD: consulting (Medtronic). David Caraway, MD, PhD: consulting (Medtronic, Spinal Modulation, MedSys, Codman). Sudhir Diwan, MD: speaking (Neurotherm, BSCI). Eric Grigsby, MD: clinical research (Alfred Mann Foundation, Medtronic, NeurogesX, Spinal Restoration), speaking (Azur Pharma), consulting (Medtronic, St. Jude Medical, Spinal Modulation, Vertos, Xalud), stock options (Spinal Modulation, Spinal Restoration, Vertos, Xalud). Marilyn Jacobs, PhD: consulting (Medtronic). Philip Kim, MD: consulting (Medtronic, Biotronik, Stryker, Azur). Krishna Kumar, MD: consulting and research (Medtronic, Boston Scientific). Michael Leong, MD: advisor (Covidien). Liong Liem, MD: grant (Spinal Modulation). Gladstone McDowell, MD: speaking (Azur), consulting (Medtronic, Mysys). Nagy Mekhail, MD, PhD: spe(Endo Pharmaceutical), research (Baylis, Inc., Vertos). Richard Rauck, MD: research (Medtronic, Medasys, Azur, Codman, Al Mann Foundation), consulting (Medtronic, Medasys, Azur), data and safety monitoring board membership (Medtronic, Al Mann Foundation). Michael Saulino, MD, PhD: speaking (Medtronic, Azur), research (Medtronic). Lisa Stearns, MD: research (Medtronic, Insys Therapeutics, Vertos), consulting (Medtronic). Mark Wallace, MD: research and consulting (Medtronic). K. Dean Willis, MD: speaking (Boston Scientific, Medtronic, St. Jude Medical), Implantable Systems Performance Registry participant (Medtronic), advisory committee (Boston Scientific). William Witt, MD: consulting (Medtronic), speaking (Cadence, Pfizer, Medtronic). José De Andrés, MD, PhD; Michael Erdek, MD; Marc Huntoon, MD, PhD; Sunil J. Panchal, MD; Peter Staats, MD; Michael Stanton-Hicks, MD; B. Todd Sitzman, MD; Michael Cousins, MD: nothing to disclose; and Tony Yaksh, PhD: consulting (Vertex, Adynxx, Solace, Neuroadjuvants, Trevana), research (Adynxx, Johnson & Johnson, Xenome, Torrey Pines, Third Rock Ventures, Advanced Targeting Systems, Nektar Pharma, Endo Pharmaceuticals, Sage Rx, Solstice, Epigen). INTRODUCTION tives of modifying and updating the IT drug selection algorithm by reviewing previous PACC guidelines including literature published The use of intraspinal (intrathecal [IT]) infusion of analgesic medica- before January 14, 2007; preclinical and clinical data on IT therapy tions to treat patients with chronic refractory pain has increased published from January 15, 2007, through March 1, 2011; and since its inception in the 1980s, and the need for clinical research in results of a peer survey. IT therapy is ongoing. Thus far, research has not kept pace with the growing need for innovative pain management; therefore, a con- sensus opinion is needed to clarify the current research and address METHODS deficiencies in the data. The Polyanalgesic Consensus Conference (PACC) panel first con- A broad literature search was conducted to identify preclinical and vened in 2000 to address the research gaps and review the existing clinical data on IT therapy published from January 15, 2007, through data (1). This expert panel is composed of physicians and other March 1, 2011. MEDLINE®, BioMed Central®, Current Contents Con- clinicians in the field of IT therapy. The panel developed an IT drug nect®, Embase, International Pharmaceutical Abstracts®, and Web of selection algorithm on the basis of best evidence and expert Science® data bases were searched for publications on a range of opinion and prepared supplemental reports that included a litera- medications that are either currently in use or potentially useful for ture review, documentation of results from a survey of peers regard- the IT treatment of chronic pain. Search terms included intrathecal, ing IT therapy, and projections for future directions in the field of IT intraspinal, morphine, fentanyl, sufentanil, methadone, adenosine, therapy. The PACC panel reconvened in 2003 (2)
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