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Review

A safety review of approved intrathecal analgesics for chronic pain management

, ORCID Icon, , , &
Pages 439-451 | Received 13 Dec 2020, Accepted 09 Feb 2021, Published online: 08 Mar 2021

References

  • Dahlhamer J, Lucas J, Zelaya C, et al. Prevalence of chronic pain and high-impact chronic pain among adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018;67(36):1001–1006. Epub 2018/ 09/14.
  • Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012;13(8):715–724. Epub 2012/ 05/23.
  • Manchikanti L, Singh V, Kaye AD, et al. Lessons for better pain management in the future: learning from the past. Pain Ther. 2020;9(2):373–391. Epub 2020/ 05/16.
  • Stoicea N, Costa A, Periel L, et al. Current perspectives on the opioid crisis in the US healthcare system: a comprehensive literature review. Medicine (Baltimore). 2019;98(20):e15425. Epub 2019/ 05/18.
  • Knight KH, Brand FM, McHaourab AS, et al. Implantable intrathecal pumps for chronic pain: highlights and updates. Croat Med J. 2007;48(1): 22–34. Epub 2007/ 02/20.
  • Pert CB, Snyder SH. Opiate receptor: demonstration in nervous tissue. Science. 1973;179(4077):1011–1014. Epub 1973/ 03/09.
  • Yaksh TL, Rudy TA. Analgesia mediated by a direct spinal action of narcotics. Science. 1976;192(4246):1357–1358. Epub 1976/ 06/25.
  • Wang JK, Nauss LA, Thomas JE. Pain relief by intrathecally applied morphine in man. Anesthesiology. 1979;50(2):149–151. Epub 1979/ 02/01.
  • Onofrio BM, Yaksh TL, Arnold PG. Continuous low-dose intrathecal morphine administration in the treatment of chronic pain of malignant origin. Mayo Clin Proc. 1981;56(8): 516–520. Epub 1981/ 08/01.
  • Deer TR, Hayek SM, Pope JE, et al. The Polyanalgesic Consensus Conference (PACC): recommendations for trialing of intrathecal drug delivery infusion therapy. Neuromodulation. 2017;20(2):133–154. Epub 2017/ 01/04.
  • Deer TR, Pope JE, Hayek SM, et al. The Polyanalgesic Consensus Conference (PACC): recommendations on intrathecal drug infusion systems best practices and guidelines. Neuromodulation. 2017;20(2):96–132. Epub 2017/ 01/04.
  • Deer TR, Pope JE, Hayek SM, et al. The Polyanalgesic Consensus Conference (PACC): recommendations for intrathecal drug delivery: guidance for improving safety and mitigating risks. Neuromodulation. 2017;20(2):155–176. Epub 2017/ 01/04.
  • Hayek SM, Hanes MC. Intrathecal therapy for chronic pain: current trends and future needs. Curr Pain Headache Rep. 2014;18(1):388. Epub 2013/ 12/18.
  • Bernards CM. Understanding the physiology and pharmacology of epidural and intrathecal opioids. Best Pract Res Clin Anaesth. 2002;16(4):489–505. Epub 2003/ 01/09.
  • Al-Hasani R, Bruchas MR. Molecular mechanisms of opioid receptor-dependent signaling and behavior. Anesthesiology. 2011;115(6):1363–1381. Epub 2011/ 10/25.
  • Hikma Pharmaceuticals USA Inc. Infumorph 200, 500- morphine sulfate injection, solution (drug label information). 2020.
  • Kotob HI, Hand CW, Moore RA, et al. Intrathecal morphine and heroin in humans: six-hour drug levels in spinal fluid and plasma. Anesth Analg. 1986;65(7):718–722. Epub 1986/ 07/01.
  • Sjostrom S, Tamsen A, Persson MP, et al. Pharmacokinetics of intrathecal morphine and meperidine in humans. Anesthesiology. 1987;67(6):889–895. Epub 1987/ 12/01.
  • Caute B, Monsarrat B, Gouarderes C, et al. CSF morphine levels after lumbar intrathecal administration of isobaric and hyperbaric solutions for cancer pain. Pain. 1988;32(2):141–146. Epub 1988/ 02/01.
  • Pope JE, Deer TR, Amirdelfan K, et al. The pharmacology of spinal opioids and ziconotide for the treatment of non-cancer pain. Curr Neuropharmacol. 2017;15(2):206–216. Epub 2016/ 02/11.
  • Bohn LM, Gainetdinov RR, Lin FT, et al. Mu-opioid receptor desensitization by beta-arrestin-2 determines morphine tolerance but not dependence. Nature. 2000;408(6813):720–723. Epub 2000/ 12/29.
  • Rauck RL, Wallace MS, Burton AW, et al. Intrathecal ziconotide for neuropathic pain: a review. Pain Pract. 2009;9(5):327–337. Epub 2009/ 08/18.
  • Newcomb R, Abbruscato TJ, Singh T, et al. Bioavailability of ziconotide in brain: influx from blood, stability, and diffusion. Peptides. 2000;21(4):491–501. Epub 2000/ 05/24.
  • Pope JE, Deer TR, Bruel BM, et al. Clinical uses of intrathecal therapy and its placement in the pain care algorithm. Pain Pract. 2016;16(8):1092–1106. Epub 2016/ 02/26.
  • Penn RD, Paice JA. Chronic intrathecal morphine for intractable pain. J Neurosurg. 1987;67(2):182–186. Epub 1987/ 08/01.
  • Onofrio BM, Yaksh TL. Long-term pain relief produced by intrathecal morphine infusion in 53 patients. J Neurosurg. 1990;72(2):200–209. Epub 1990/ 02/01.
  • Follett KA, Hitchon PW, Piper J, et al. Response of intractable pain to continuous intrathecal morphine: a retrospective study. Pain. 1992;49(1):21–25. Epub 1992/ 04/01
  • Winkelmuller M, Winkelmuller W. Long-term effects of continuous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg. 1996;85(3):458–467. Epub 1996/ 09/01
  • Anderson VC, Burchiel KJ. A prospective study of long-term intrathecal morphine in the management of chronic nonmalignant pain. Neurosurgery. 1999;44(2):289–300. Epub 1999/ 02/05. discussion −1.
  • Kumar K, Kelly M, Pirlot T. Continuous intrathecal morphine treatment for chronic pain of nonmalignant etiology: long-term benefits and efficacy. Surg Neurol. 2001;55(2):79–86. Epub 2001/ 04/13. discussion −8.
  • Rauck RL, Cherry D, Boyer MF, et al. Long-term intrathecal opioid therapy with a patient-activated, implanted delivery system for the treatment of refractory cancer pain. J Pain. 2003;4(8):441–447. Epub 2003/ 11/19.
  • Duse G, Davia G, White PF. Improvement in psychosocial outcomes in chronic pain patients receiving intrathecal morphine infusions. Anesth Analg. 2009;109(6):1981–1986. Epub 2009/ 11/20.
  • Rauck R, Deer T, Rosen S, et al. Accuracy and efficacy of intrathecal administration of morphine sulfate for treatment of intractable pain using the prometra((r)) programmable pump. Neuromodulation. 2010;13(2):102–108. Epub 2010/ 04/01.
  • Saltari MR, Shaladi A, Piva B, et al. The management of pain from collapse of osteoporotic vertebrae with continuous intrathecal morphine infusion. Neuromodulation. 2007;10(2):167–176. Epub 2007/ 04/01.
  • Lara NA Jr., Teixeira MJ, Fonoff ET. Long term intrathecal infusion of opiates for treatment of failed back surgery syndrome. Acta Neurochirurgica Suppl. 2011;108: 41–47. Epub 2010/ 11/26.
  • Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10):1304–1313. Epub 2012/ 08/01.
  • Kim JH, Jung JY, Cho MS. Continuous intrathecal morphine administration for cancer pain management using an intrathecal catheter connected to a subcutaneous injection port: a retrospective analysis of 22 terminal cancer patients in Korean population. Korean J Pain. 2013;26(1):32–38. Epub 2013/ 01/24.
  • Sommer B, Karageorgos N, AlSharif M, et al. Long-term outcome and adverse events of intrathecal opioid therapy for nonmalignant pain syndrome. Pain Pract. 2020;20(1):8–15. Epub 2019/ 07/11.
  • Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):4040–4049. Epub 2002/ 09/28.
  • Raphael JH, Duarte RV, Southall JL, et al. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):7. Epub 2013/ 08/02.
  • Duarte RV, Raphael JH, Haque MS, et al. A predictive model for intrathecal opioid dose escalation for chronic non-cancer pain. Pain Physician. 2012;15(5): 363–369. Epub 2012/ 09/22.
  • Duarte RV, Raphael JH, Sparkes E, et al. Long-term intrathecal drug administration for chronic nonmalignant pain. J Neurosurg Anesthesiol. 2012;24(1):63–70. Epub 2011/ 09/10.
  • Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011;14(4): 343–351. Epub 2011/ 07/26.
  • Grider JS, Etscheidt MA, Harned ME, et al. Trialing and maintenance dosing using a low-dose intrathecal opioid method for chronic nonmalignant pain: a prospective 36-month study. Neuromodulation. 2016;19(2):206–219. Epub 2015/ 10/20.
  • Staats PS, Yearwood T, Charapata SG, et al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. Jama. 2004;291(1):63–70. Epub 2004/ 01/08.
  • Wallace MS, Charapata SG, Fisher R, et al. Intrathecal ziconotide in the treatment of chronic nonmalignant pain: a randomized, double-blind, placebo-controlled clinical trial. Neuromodulation. 2006;9(2):75–86. Epub 2006/ 04/01.
  • Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):393–406. Epub 2006/ 05/24.
  • Raffaeli W, Sarti D, Demartini L, et al. Italian registry on long-term intrathecal ziconotide treatment. Pain Physician. 2011;14(1): 15–24. Epub 2011/ 01/27.
  • Shao MM, Khazen O, Hellman A, et al. Effect of first-line ziconotide intrathecal drug therapy for neuropathic pain on disability, emotional well-being, and pain catastrophizing. World Neurosurg. 2020;145: e340–e347. Epub 2020/ 10/24.
  • Brookes ME, Eldabe S, Batterham A. Ziconotide monotherapy: a systematic review of randomised controlled trials. Curr Neuropharmacol. 2017;15(2):217–231. Epub 2016/ 02/11.
  • Fisher R, Hassenbusch S, Krames E, et al. A consensus statement regarding the present suggested titration for prialt (ziconotide). Neuromodulation. 2005;8(3):153–154. Epub 2005/ 07/01.
  • Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11(1):40–49. Epub 2008/ 01/01.
  • Webster LR, Fisher R, Charapata S, et al. Long-term intrathecal ziconotide for chronic pain: an open-label study. J Pain Symptom Manage. 2009;37(3):363–372. Epub 2008/ 08/22.
  • McDowell GC 2nd, Pope JE. Intrathecal ziconotide: dosing and administration strategies in patients with refractory chronic pain. Neuromodulation. 2016;19(5):522–532. Epub 2016/ 02/10.
  • Pope JE, Deer TR. Intrathecal pharmacology update: novel dosing strategy for intrathecal monotherapy ziconotide on efficacy and sustainability. Neuromodulation. 2015;18(5):414–420. Epub 2015/ 02/25.
  • Mohammed SI, Eldabe S, Simpson KH, et al. Bolus intrathecal injection of ziconotide (Prialt(R)) to evaluate the option of continuous administration via an implanted intrathecal drug delivery (ITDD) system: a pilot study. Neuromodulation discussion 82. 2013;16(6):576–582. Epub 2012/ 12/05.
  • Pope JE, Deer TR. Ziconotide: a clinical update and pharmacologic review. Expert Opin Pharmacother. 2013;14(7):957–966. Epub 2013/ 03/30.
  • Smith HS, Deer TR. Safety and efficacy of intrathecal ziconotide in the management of severe chronic pain. Ther Clin Risk Manag. 2009;5(3):521–534. Epub 2009/ 08/27.
  • TerSera Therapeutics LLC. Prialt- ziconotide injection, solution (drug label information). 2019.
  • Prager J, Deer T, Levy R, et al. Best practices for intrathecal drug delivery for pain. Neuromodulation discussion 72. 2014;17(4):354–372. Epub 2014/ 01/23.
  • Mitchell AA, Sapienza-Crawford AJ, Hanley KL, et al. Administering ziconotide and monitoring patients treated with ziconotide: expert opinions pain management nursing. Off J Am Soc Pain Manage Nurs. 2013;14(3):e84–94.
  • Prusik J, Argoff C, Peng S, et al. Use of low dose ziconotide as first-line intrathecal monotherapy. Neuromodulation. 2017;20(4):386–391. Epub 2016/ 08/06.
  • Kato R, Shimamoto H, Terui K, et al. Delayed respiratory depression associated with 0.15 mg intrathecal morphine for cesarean section: a review of 1915 cases. J Anesth. 2008;22(2):112–116. Epub 2008/ 05/27.
  • Shapiro A, Zohar E, Zaslansky R, et al. The frequency and timing of respiratory depression in 1524 postoperative patients treated with systemic or neuraxial morphine. J Clin Anesth. 2005;17(7):537–542. Epub 2005/ 11/22.
  • Sultan P, Gutierrez MC, Carvalho B. Neuraxial morphine and respiratory depression: finding the right balance. Drugs. 2011;71(14):1807–1819. Epub 2011/ 09/29.
  • Heinricher MM, Drasner K. Lumbar intrathecal morphine alters activity of putative nociceptive modulatory neurons in rostral ventromedial medulla. Brain Res. 1991;549(2):338–341. Epub 1991/ 05/24.
  • Morgan MM, Heinricher MM, Fields HL. Circuitry linking opioid-sensitive nociceptive modulatory systems in periaqueductal gray and spinal cord with rostral ventromedial medulla. Neuroscience. 1992;47(4):863–871. Epub 1992/ 01/01.
  • Coffey RJ, Owens ML, Broste SK, et al. Medical practice perspective: identification and mitigation of risk factors for mortality associated with intrathecal opioids for non-cancer pain. Pain Med. 2010;11(7):1001–1009. Epub 2010/ 07/21.
  • Cabbell KL, Taren JA, Sagher O. Spinal cord compression by catheter granulomas in high-dose intrathecal morphine therapy: case report. Neurosurgery. 1998;42(5):1176–1180. Epub 1998/ 05/20. discussion 80-1.
  • North RB, Cutchis PN, Epstein JA, et al. Spinal cord compression complicating subarachnoid infusion of morphine: case report and laboratory experience. Neurosurgery. 1991;29(5):778–784. Epub 1991/ 11/01.
  • Coffey RJ, Burchiel K. Inflammatory mass lesions associated with intrathecal drug infusion catheters: report and observations on 41 patients. Neurosurgery. 2002;50(1):78–86. Epub 2002/ 02/15. discussion −7.
  • Duarte RV, Raphael JH, Southall JL, et al. Intrathecal granuloma formation as result of opioid delivery: systematic literature review of case reports and analysis against a control group. Clin Neurol Neurosurg. 2012;114(6):577–584. Epub 2011/ 12/30.
  • McMillan MR, Doud T, Nugent W. Catheter-associated masses in patients receiving intrathecal analgesic therapy. Anesth Analg. 2003;96(1):186–190. Epub 2002/ 12/31. table of contents.
  • Hu K, Connelly NR, Vieira P. Withdrawal symptoms in a patient receiving intrathecal morphine via an infusion pump. J Clin Anesth. 2002;14(8):595–597. Epub 2003/ 02/05.
  • Abs R, Verhelst J, Maeyaert J, et al. Endocrine consequences of long-term intrathecal administration of opioids. J Clin Endocrinol Metab. 2000;85(6):2215–2222. Epub 2000/ 06/14.
  • Chinachoti T, Nilrat P, Samarnpiboonphol P. Nausea, vomiting and pruritus induced by intrathecal morphine. J Med Assoc Thai. 2013;96(5): 589–594. Epub 2013/ 06/12.
  • Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10(2): 357–366. Epub 2007/ 03/28.
  • Duarte RV, Raphael JH, Southall JL, et al. Hypogonadism and low bone mineral density in patients on long-term intrathecal opioid delivery therapy. BMJ Open. 2013;3(6):6. Epub 2013/ 06/26.
  • Aldrete JA, Couto Da Silva JM. Leg edema from intrathecal opiate infusions. Eur J Pain. 2000;4(4):361–365. Epub 2000/ 12/22.
  • Veizi E, Tornero-Bold M, Hayek SM. Resolution of intrathecal hydromorphone or morphine-induced peripheral edema by opioid rotation to fentanyl: a case series. Pain Pract. 2016;16(6):E94–8. Epub 2016/ 03/19.
  • Tomaszewski D, Balkota M, Truszczynski A, et al. Intrathecal morphine increases the incidence of urinary retention in orthopaedic patients under spinal anaesthesia. Anaesthesiol Intensive Ther. 2014;46(1):29–33. Epub 2014/ 03/20.
  • Dooley DJ, Taylor CP, Donevan S, et al. Ca2+ channel alpha2delta ligands: novel modulators of neurotransmission. Trends Pharmacol Sci. 2007;28(2):75–82. Epub 2007/ 01/16.
  • Maier C, Gockel HH, Gruhn K, et al. Increased risk of suicide under intrathecal ziconotide treatment? - a warning. Pain. 2011;152(1):235–237. Epub 2010/ 11/03.
  • Burdge G, Leach H, Walsh K. Ziconotide-induced psychosis: a case report and literature review. Ment Health Clin. 2018;8(5):242–246. Epub 2018/ 09/13.
  • Deer TR, Pope JE, Hanes MC, et al. Intrathecal therapy for chronic pain: a review of morphine and ziconotide as firstline options. Pain Med. 2019;20(4):784–798. Epub 2018/ 08/24.
  • Rezai A, Kloth D, Hansen H, et al. Physician response to medtronic’s position on the use of off-label medications in the synchromed pump. Neuromodulation. 2013;16(5):398–400. Epub 2014/ 03/04.
  • Sjogren P, Thunedborg LP, Christrup L, et al. Is development of hyperalgesia, allodynia and myoclonus related to morphine metabolism during long-term administration? Six case histories. Acta Anaesthesiol Scand. 1998;42(9):1070–1075. Epub 1998/ 11/11.
  • Ma K, Jin Y, Wang L, et al. Intrathecal delivery of hydromorphone vs morphine for refractory cancer pain: a multicenter, randomized, single-blind, controlled noninferiority trial. Pain. 2020;161(11):2502–2510. Epub 2020/ 06/23.
  • Flack SH, Bernards CM. Cerebrospinal fluid and spinal cord distribution of hyperbaric bupivacaine and baclofen during slow intrathecal infusion in pigs. Anesthesiology. 2010;112(1):165–173. Epub 2009/ 12/10.
  • Deer T, Kim P, Pope JE, et al. Physician guidance on the use of off-labeled drugs in intrathecal drug delivery systems for chronic pain. Neuromodulation. 2019;22(7):765–768. Epub 2019/ 05/01.
  • Alicino I, Giglio M, Manca F, et al. Intrathecal combination of ziconotide and morphine for refractory cancer pain: a rapidly acting and effective choice. Pain. 2012;153(1):245–249. Epub 2011/ 11/16.
  • JA W, Day M, JE H. Ziconotide: an update and review. Expert Opin Pharmacother. 2008;9(9):1575–1583. Epub 2008/ 06/04.
  • McDowell GC, Saulino MF, Wallace M, et al. Effectiveness and safety of intrathecal ziconotide: final results of the Patient Registry of Intrathecal Ziconotide Management (PRIZM). Pain Med. 2020;21(11):2925–2938. Epub 2020/ 05/31.
  • Dupoiron D, Bore F, Lefebvre-Kuntz D, et al. Ziconotide adverse events in patients with cancer pain: a multicenter observational study of a slow titration, multidrug protocol. Pain Physician. 2012;15(5):395–403. Epub 2012/ 09/22.
  • Staudt MD, Patel S, Hellman A, et al. Efficacy of simultaneous usage of spinal cord stimulation and intrathecal therapy for nonmalignant chronic neuropathic pain. World Neurosurg. 2020;143: e442–e449. Epub 2020/ 08/05.
  • Tomycz ND, Ortiz V, Moossy JJ. Simultaneous intrathecal opioid pump and spinal cord stimulation for pain management: analysis of 11 patients with failed back surgery syndrome. J Pain Palliat Care Pharmacother. 2010;24(4):374–383. Epub 2010/ 12/08.

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