Oliceridine in Patients With Acute Burn Injuries

Summary

Pain after acute burn injury is complex with much still not understood. The primary mechanism is believed to be nociceptive, but is interwoven with aspects of somatogenic, neuropathic, and psychogenic pathways. As such, opioid receptor agonists are an essential component for pain management after burn injury. The majority of wound care and dressing changes are completed in non-intubated patients and rates of respiratory depression concerning. Oliceridine is a biased, selective MOR agonist approved for treatment of acute pain. To date there is no literature of use in patients with burn injuries. While it should be effective, efficacy and the potential for reduced adverse events need to be quantified. Current practice and guidelines, plead for better analgesia for patients with burn injuries.

Timeline

Start

2023-04-01

Primary completion

2023-09-30

Completion

2023-10-24

Publications

• Background James DL, Jowza M. Principles of Burn Pain Management. Clin Plast Surg. 2017 Oct;44(4):737-747. doi: 10.1016/j.cps.2017.05.005. Epub 2017 Jul 15.
• Background Romanowski KS, Carson J, Pape K, Bernal E, Sharar S, Wiechman S, Carter D, Liu YM, Nitzschke S, Bhalla P, Litt J, Przkora R, Friedman B, Popiak S, Jeng J, Ryan CM, Joe V. American Burn Association Guidelines on the Management of Acute Pain in the Adult Burn Patient: A Review of the Literature, a Compilation of Expert Opinion and Next Steps. J Burn Care Res. 2020 Nov 30;41(6):1152-1164. doi: 10.1093/jbcr/iraa120. No abstract available.
• Background Thompson EM, Andrews DD, Christ-Libertin C. Efficacy and safety of procedural sedation and analgesia for burn wound care. J Burn Care Res. 2012 Jul-Aug;33(4):504-9. doi: 10.1097/BCR.0b013e318236fe4f.
• Background Myers R, Lozenski J, Wyatt M, Pena M, Northrop K, Bhavsar D, Kovac A. Sedation and Analgesia for Dressing Change: A Survey of American Burn Association Burn Centers. J Burn Care Res. 2017 Jan/Feb;38(1):e48-e54. doi: 10.1097/BCR.0000000000000423.
• Background Wibbenmeyer L, Oltrogge K, Kluesner K, Zimmerman MB, Kealey PG. An evaluation of discharge opioid prescribing practices in a burn population. J Burn Care Res. 2015 Mar-Apr;36(2):329-35. doi: 10.1097/BCR.0000000000000110.
• Background Wibbenmeyer L, Eid A, Kluesner K, Heard J, Zimmerman B, Kealey GP, Brennan T. An Evaluation of Factors Related to Postoperative Pain Control in Burn Patients. J Burn Care Res. 2015 Sep-Oct;36(5):580-6. doi: 10.1097/BCR.0000000000000199.
• Background Kaul I, Amin A, Rosenberg M, Rosenberg L, Meyer WJ 3rd. Use of gabapentin and pregabalin for pruritus and neuropathic pain associated with major burn injury: A retrospective chart review. Burns. 2018 Mar;44(2):414-422. doi: 10.1016/j.burns.2017.07.018. Epub 2017 Aug 16.
• Background Wibbenmeyer L, Eid A, Liao J, Heard J, Horsfield A, Kral L, Kealey P, Rosenquist R. Gabapentin is ineffective as an analgesic adjunct in the immediate postburn period. J Burn Care Res. 2014 Mar-Apr;35(2):136-42. doi: 10.1097/BCR.0b013e31828a4828.
• Background Jones LM, Uribe AA, Coffey R, Puente EG, Abdel-Rasoul M, Murphy CV, Bergese SD. Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study. Medicine (Baltimore). 2019 May;98(18):e15343. doi: 10.1097/MD.0000000000015343.
• Background Meyer WJ 3rd, Nichols RJ, Cortiella J, Villarreal C, Marvin JA, Blakeney PE, Herndon DN. Acetaminophen in the management of background pain in children post-burn. J Pain Symptom Manage. 1997 Jan;13(1):50-5. doi: 10.1016/s0885-3924(96)00201-1.
• Background Retrouvey H, Shahrokhi S. Pain and the thermally injured patient-a review of current therapies. J Burn Care Res. 2015 Mar-Apr;36(2):315-23. doi: 10.1097/BCR.0000000000000073.
• Background Pal SK, Cortiella J, Herndon D. Adjunctive methods of pain control in burns. Burns. 1997 Aug;23(5):404-12. doi: 10.1016/s0305-4179(97)00029-6.
• Background Yang C, Xu XM, He GZ. Efficacy and feasibility of opioids for burn analgesia: An evidence-based qualitative review of randomized controlled trials. Burns. 2018 Mar;44(2):241-248. doi: 10.1016/j.burns.2017.10.012. Epub 2017 Nov 21.
• Background Ly E, Velamuri S, Hickerson W, Hill DM, Desai J, Tsui B, Herr M, Jones J. Approaching trauma analgesia using prolonged and novel continuous peripheral nerve blocks - A case report. Anesth Pain Med (Seoul). 2022 Jan;17(1):87-92. doi: 10.17085/apm.21029. Epub 2021 Jul 22.
• Background MacPherson RD, Woods D, Penfold J. Ketamine and midazolam delivered by patient-controlled analgesia in relieving pain associated with burns dressings. Clin J Pain. 2008 Sep;24(7):568-71. doi: 10.1097/AJP.0b013e31816cdb20.
• Background Lintner AC, Brennan P, Miles MVP, Leonard C, Alexander KM, Kahn SA. Oral Administration of Injectable Ketamine During Burn Wound Dressing Changes. J Pharm Pract. 2021 Jun;34(3):423-427. doi: 10.1177/0897190019876497. Epub 2019 Sep 19.
• Background Brennan PG, Landry JK, Miles MVP, Lintner AC, McGinn KA, Kahn SA. Intravenous Ketamine as an Adjunct to Procedural Sedation During Burn Wound Care and Dressing Changes. J Burn Care Res. 2019 Feb 20;40(2):246-250. doi: 10.1093/jbcr/iry044.
• Background DeWire SM, Ahn S, Lefkowitz RJ, Shenoy SK. Beta-arrestins and cell signaling. Annu Rev Physiol. 2007;69:483-510. doi: 10.1146/annurev.physiol.69.022405.154749.
• Background Raehal KM, Walker JK, Bohn LM. Morphine side effects in beta-arrestin 2 knockout mice. J Pharmacol Exp Ther. 2005 Sep;314(3):1195-201. doi: 10.1124/jpet.105.087254. Epub 2005 May 25.
• Background Luttrell LM, Lefkowitz RJ. The role of beta-arrestins in the termination and transduction of G-protein-coupled receptor signals. J Cell Sci. 2002 Feb 1;115(Pt 3):455-65. doi: 10.1242/jcs.115.3.455.
• Background DeWire SM, Yamashita DS, Rominger DH, Liu G, Cowan CL, Graczyk TM, Chen XT, Pitis PM, Gotchev D, Yuan C, Koblish M, Lark MW, Violin JD. A G protein-biased ligand at the mu-opioid receptor is potently analgesic with reduced gastrointestinal and respiratory dysfunction compared with morphine. J Pharmacol Exp Ther. 2013 Mar;344(3):708-17. doi: 10.1124/jpet.112.201616. Epub 2013 Jan 8.
• Background Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.
• Background Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
• Background Bergese SD, Brzezinski M, Hammer GB, Beard TL, Pan PH, Mace SE, Berkowitz RD, Cochrane K, Wase L, Minkowitz HS, Habib AS. ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The micro-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy. J Pain Res. 2019 Nov 14;12:3113-3126. doi: 10.2147/JPR.S217563. eCollection 2019.
• Background Nafziger AN, Arscott KA, Cochrane K, Skobieranda F, Burt DA, Fossler MJ. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine. Clin Pharmacol Drug Dev. 2020 Jul;9(5):639-650. doi: 10.1002/cpdd.750. Epub 2019 Nov 7.
• Background Fossler MJ, Sadler BM, Farrell C, Burt DA, Pitsiu M, Skobieranda F, Soergel DG. Oliceridine (TRV130), a Novel G Protein-Biased Ligand at the mu-Opioid Receptor, Demonstrates a Predictable Relationship Between Plasma Concentrations and Pain Relief. I: Development of a Pharmacokinetic/Pharmacodynamic Model. J Clin Pharmacol. 2018 Jun;58(6):750-761. doi: 10.1002/jcph.1076. Epub 2018 Feb 7.

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