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Strategies for Acute Pain Management in Patients on Extended-Release Naltrexone. Megan T. Mitchell , PharmD PGY1 Pharmacy Resident UConn John Dempsey Hospital. May 8 th , 2018 Eastern States Residency Conference. Disclosure. I have no conflict of interest to report
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Strategies for Acute Pain Management in Patients on Extended-Release Naltrexone Megan T. Mitchell, PharmD PGY1 Pharmacy Resident UConn John Dempsey Hospital May 8th, 2018 Eastern States Residency Conference
Disclosure • I have no conflict of interest to report • I intend to reference unlabeled/unapproved uses of drugs or products in my presentation
Learning Objectives • List the FDA-approved indications for the use of extended-release naltrexone • Identify appropriate non-opioid analgesic treatment options beyond the standard of care, for the management of severe, acute pain in patients on extended-release naltrexone injectable suspension
Extended-Release Naltrexone(ERN) • Once monthly intramuscular injection • Indications • Treatment of alcohol dependence • Treatment of opioid dependence following detoxification • Opioid antagonist • Highest affinity for the mu opioid receptor • Extended Release Naltrexone Injectable Solution [package Insert]. Waltham, MA: Alkermes, Inc. 2015
Pharmacokinetics of ERN • Duration of action of ERN is approximately 28 days • Important to assess the time of last injection • The blockade is surmountable with high dose opiates • Increased risk of respiratory depression and death • Extended Release Naltrexone Injectable Solution [package Insert]. Waltham, MA: Alkermes, Inc. 2015
Challenges of using ERN • Patient education is essential • Patients should be highly self-motivated • Risk of overdose if using higher doses than before • Willingness to communicate to other providers • Adherence to once monthly injection schedule • Provider education
Challenges of using ERN • Currently no universal method for identifying these patients • Altered mental status or unconscious • Not dispensed through retail pharmacy • Not reported on PMP • Access to EMR is often limited • Stigma related to use • Highly encourage patients to utilize medical alert bracelets/tags
Elective Procedures • Appropriate communication between healthcare professionals is key • Track dates of administration • Schedule elective procedures to fall as close to day 28 as possible • Opioids can be used for acute post-op pain
Standard of Care • Acetaminophen • NSAIDs • Skeletal muscle relaxants • Baclofen, cyclobenzaprine, tizanidine • Anticonvulsants • Gabapentin, pregabalin • Benzodiazepines • Diazepam, midazolam, lorazepam, alprazolam
Clinical Question What strategies are available to treat severe, acute pain if these standard of care methods are not providing adequate relief and opioids are not an option?
Ketamine • A non-competitive NMDA and glutamate receptor antagonist with potent analgesic, anxiolytic and amnestic properties • Rapid onset of action • Preserves airway patency, ventilation and cardiovascular stability 1. White PF, Way WL, & Trevor AJ: Ketamine - its pharmacology and therapeutic uses. Anesthesiology 1982; 56:119-136. 2. Ketamine hydrochloride injection solution [package Insert]. Lake Forrest, IL: Hospira Co. 2004
Ketamine • Anesthetic dosing • 1- 4.5 mg/kg bolus • 0.5 mg/kg/min • Sub-dissociative dosing • 0.2-0.8 mg/kg bolus • 0.1-0.3 mg/kg/hrcontinuous infusion • Titration based on pain control and signs of CNS/CV side effects • White PF, Way WL, & Trevor AJ: Ketamine - its pharmacology and therapeutic uses. Anesthesiology 1982; 56:119-136. • Gurnani A, Sharma PK, Rautela RS, et al: Analgesia for acute musculoskeletal trauma: low-dose subcutaneous infusion of ketamine. Anaesth Intensive Care 1996; 24:32-36 • Ketamine hydrochloride injection solution [package Insert]. Lake Forrest, IL: Hospira Co. 2004
Dissociation and Emergence • Dissociation: patient passes into a trance like state • At the doses used for pain, this side effect is less common • Emergence: gradual return of consciousness after discontinuing administration of an anesthetic • May be accompanied by psychotomimetic effects PerumalDK, Adhimoolam M, Selvaraj N, Lazarus SP, Mohammed MAR. Midazolam premedication for Ketamine-induced emergence phenomenon: A prospective observational study. Journal of Research in Pharmacy Practice. 2015;4(2):89-93.
Ketamine • Risks to consider • Increased BP and HR • Respiratory depression • Following rapid IV pushes of high doses • Diplopia or nystagmus • Slightly elevated intraocular pressure • Enhanced skeletal muscle tone • Manifested by tonic-clonic movements Ketamine hydrochloride injection solution [package Insert]. Lake Forrest, IL: Hospira Co. 2004
Peripheral Nerve Blocks (PNB) • Continuous PNB vs. Single shot PNB • Used for localized injuries • Performed by injection of the anesthetic adjacent to a nerve or nerve plexus of interest Girish Joshi. “Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities.” Journal of Clinical Anesthesia, 10 Aug. 2016. Pubmed, Accessed 23 Aug. 2017
Peripheral Nerve Blocks • Can contain many combinations of drugs • Local anesthetics • Corticosteroids • Sodium bicarbonate • Epinephrine • Often contain an opioid for additional analgesia • Avoid in patients on ERN
Additives • Sodium Bicarbonate • Used to decrease the time to onset of a block by ensuring molecules are in their uncharged, basic form to cross the nerve membrane • Epinephrine • Vasoconstrictor to slow absorption into tissues which can decrease toxicity and prolong duration of block • Corticosteroids • May help to prolong analgesia after PNB Neal JM, Gerancher JC, Hebl JR, et al. Upper extremity regional anesthesia: essentials of our current understanding, 2008. RegAnesth Pain Med 2009; 34:134.
Peripheral Nerve Blocks • Risks to consider • Perineural hematomas • Neurologic complications • Tingling, pain on pressure, pins and needles • Local anesthetic systemic toxicity (LAST) • Dose-dependent • Metallic taste, tinnitus, perioral numbness, seizure, cardiac arrest, death Girish Joshi. “Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities.” Journal of Clinical Anesthesia, 10 Aug. 2016. Pubmed, Accessed 23 Aug. 2017
Epidural with Local Anesthetics • Can be used for anesthesia of abdomen, pelvis, and lower extremities • Performed by placing a catheter into the epidural space • Using the same combinations of anesthetic and adjuvants as used in peripheral blocks • Veering BT, Cousins MJ. Epidural neural blockade. In: Cousins & Bridenbaugh's Neural Blockade in Clinical Anesthesia and Pain Medicine, 4th ed, Cousins MJ, Carr DB, Horlocker TT, Bridenbaugh PO (Eds), Lippincott Williams & Wilkins, Philadelphia 2009.
Epidural with Local Anesthetics • Post Dural Puncture Headache (PDPH) • Frontal or occipital headache • Within 6 to 72 hours of the procedure • Occurs due to inadvertent puncture of the dura • Results in leakage of cerebral spinal fluid • Headache can last 2 - 15 days without treatment Kuntz KM, Kokmen E, Stevens JC, et al. Post-lumbar puncture headaches: experience in 501 consecutive procedures. Neurology 1992; 42:1884.
Treatment of PDPH • Epidural blood patch • Blood is injected epidurally at or near the site of the prior LP • Volume replacementand sealing of the CSF leak • Alternate therapies • The limited available data suggest modest effectiveness for gabapentin, hydrocortisone, and theophylline BoonmakP, Boonmak S. Epidural blood patching for preventing and treating post-dural puncture headache. Cochrane Database Syst Rev 2010; :CD001791. 27.Sandesc D, Lupei MI, Sirbu C, et al. Conventional treatment or epidural blood patch for the treatment of different etiologies of post dural puncture headache. ActaAnaesthesiolBelg 2005; 56:265.
Technique • Injection into epidural space vs. around peripheral nerve plexus • Technique is important • Inappropriate placement can be dangerous and very uncomfortable for the patient
Barriers to Epidural Use • Coagulation status • Sepsis or infection at the site • Increased intracranial pressure • Low platelet count • Uncorrected hypovolemia • Anesthesiologists may be required to follow patient until epidural is removed
Test Your Knowledge Which of the following is not an FDA approved indication for the use of Extended-Release Naltrexone? • Alcohol dependence • Opioid dependence • Opioid detoxification • All of the above
Test Your Knowledge Which of the following is not an FDA approved indication for the use of Extended-Release Naltrexone? • Alcohol dependence • Opioid dependence • Opioid detoxification • All of the above
Test Your Knowledge Which of the following doses of ketamine is appropriate for the management of severe pain in a patient who is on ERN and arrives at the ED with a broken femur s/p MVA? • 0.2-0.8 mg/kg bolus followed by 0.1-0.3 mg/kg/min • 1- 4.5 mg/kg bolus followed by 0.5 mg/kg/min • 0.2-0.8 mg/kg bolus followed by 0.1-0.3 mg/kg/hr • 1- 4.5 mg/kg bolus followed by 1 mg/kg/hr
Test Your Knowledge Which of the following doses of ketamine is appropriate for the management of severe pain in a patient who is on ERN and arrives at the ED with a broken femur s/p MVA? • 0.2-0.8 mg/kg bolus followed by 0.1-0.3 mg/kg/min • 1- 4.5 mg/kg bolus followed by 0.5 mg/kg/min • 0.2-0.8 mg/kg bolus followed by 0.1-0.3 mg/kg/hr • 1- 4.5 mg/kg bolus followed by 1 mg/kg/hr
Take Home Points • Identify appropriate non-opioid analgesic treatment strategies for the management of severe, acute pain in patients on ERN • Providing pain relief is challenging • Use combinations of medications • Educate patients and other providers • Utilize an interprofessional approach
Strategies for Acute Pain Management in Patients on Extended-Release Naltrexone Megan T. Mitchell, PharmD PGY1 Pharmacy Resident UConn John Dempsey Hospital memitchell@uchc.edu