[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07145346":3,"trial-entities:NCT07145346":134,"trial-summary:NCT07145346":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":52,"sex":65,"minimum_age":66,"maximum_age":67,"healthy_volunteers":68,"eligibility_criteria":69,"std_ages":90,"locations":93,"central_contacts":102,"overall_officials":103,"references":104,"see_also_links":133},"NCT07145346","7663","Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures","Suzetrigine for Acute Pain Control in Patients With Multiple Rib Fractures: A Randomized Controlled Trial","ENROLLING_BY_INVITATION","2027-08","2025-12","2025-12-08","2025-11-13","University of California, Irvine","OTHER",true,"Rib fractures cause a significant amount of pain and are associated with an increased risk of lung infections, long hospitalization, and increased cost. Effective pain control is the cornerstone of management to improve lung function and minimize complications. Most often this is done with a multimodal pain routine consisting of: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), topical lidocaine, muscle relaxants, and opioids. However, suzetrigine is a promising alternative to treat acute pain associated with rib fractures. We think the addition of suzetrigine to a multimodal pain regimen will improve pain and decrease opioid use.","Rib fractures are a common and painful injury associated with increased risk of pneumonia, prolonged hospitalization, and higher healthcare utilization. In a national database review, rib fractures were associated with a 10% mortality rate, with mortality increasing incrementally with each additional rib fractured. Effective analgesia is essential in management of these injuries, as improved pain control optimizes pulmonary mechanics and reduces complications. Current analgesic strategies include multimodal pain regimens consisting of oral and transdermal analgesics or regional anesthetics such as epidural catheters. Historically, opioids have been a major component of analgesia, however they are highly addictive and can lead to respiratory depression and epidurals are invasive procedures with associated risks.\n\nSuzetrigine (Journavx) is a newly United States Food and Drug Administration (FDA)-approved, oral non-opioid analgesic that selectively inhibits the NaV1.8 voltage-gated sodium channel, which is solely expressed in peripheral nociceptive neurons. A systematic review including multiple phase III trials demonstrated suzetrigine's efficacy for pain management in both non-surgical and post-surgical patients. Suzetrigine has also been shown to have comparable analgesia to oral opioids with fewer side effects, such as nausea, vomiting, and need for rescue pain medication.",[19],"Rib Fractures",[21,22,23,24],"blunt chest trauma","rib fractures","Suzetrigine","multimodal pain regimen","INTERVENTIONAL","TREATMENT",[28],"PHASE4",{"count":30,"type":31},80,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Suzetrigine (SUZ)","The intervention arm will receive oral suzetrigine (100 mg loading dose followed by 50 mg every 12 hours).",[38],"Suzetrigine arm",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Placebo","The control arm will receive placebo capsules matched to suzetrigine for oral administration.",[43],"Control arm",[45,49],{"measure":46,"description":47,"timeFrame":48},"Evaluation of Pain","Pain will be measured on a numerical pain scale from 0 (no pain) to 10 (most pain). Higher pain scores equate to worse outcomes.","Through study completion of index hospitalization (up to 2 years)",{"measure":50,"description":51,"timeFrame":48},"Use of morphine and morphine equivalents","Oral morphine equivalents (OME) - A study team member will do a chart review and collect morphine used by the patients.",[53,56,59,62],{"measure":54,"description":55,"timeFrame":48},"Epidural Administration","Epidural use - patients that fail pain management will be offered an epidural",{"measure":57,"description":58,"timeFrame":48},"Time in the Hospital","ICU length of stay - number of days in the ICU Hospital length of stay - number of days admitted to the acute care hospital",{"measure":60,"description":61,"timeFrame":48},"Respiratory Complications","Respiratory complications - include events such as unplanned intubation, pneumonia, pneumothorax and incentive spirometry",{"measure":63,"description":64,"timeFrame":48},"Mortality","Mortality - in-hospital mortality rate and 30-day mortality","ALL","18 Years",null,false,{"inclusion":70,"exclusion":75,"raw_text":89},[71,72,73,74],"\\> 18 years old","Blunt trauma patients","\\> 3 rib fractures","Able to tolerate oral intake",[76,77,78,79,80,81,82,83,84,85,86,87,88],"\\\u003C 17 years old","Pregnant","Prisoners","History of adverse reaction to suzetrigine","Current strong CYP3A inhibitor medication use","Current strong or moderate CYP3A inducer","Strong Inducers: apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor and ivacaftor, mitotane, phenytoin, rifampin","Moderate Inducers: bexarotene (Systemic), bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, estradiol, and norethindrone, eslicarbazepine, etravirine, fexinidazole, lorlatinib, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, phenobarbital, primidone, repotrectinib, rifabutin, rifapentine, sotorasib, St John's Wort","Cirrhosis","GCS \\\u003C 14","Rhabdomyolysis (CPK \\> 5,000 U\u002FL)","Chronic opioid use (\\>30mg OME\u002Fday)","Known or suspected active infection with human immunodeficiency virus or hepatitis B or C viruses","Inclusion Criteria:\n\n* \\> 18 years old\n* Blunt trauma patients\n* \\> 3 rib fractures\n* Able to tolerate oral intake\n\nExclusion Criteria:\n\n* \\\u003C 17 years old\n* Pregnant\n* Prisoners\n* History of adverse reaction to suzetrigine\n* Current strong CYP3A inhibitor medication use\n\n  o Strong Inhibitors: clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, atazanavir, darunavir, indinavir, lopinavir, telithromycin\n* Current strong or moderate CYP3A inducer\n\n  * Strong Inducers: apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor and ivacaftor, mitotane, phenytoin, rifampin\n  * Moderate Inducers: bexarotene (Systemic), bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, estradiol, and norethindrone, eslicarbazepine, etravirine, fexinidazole, lorlatinib, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, phenobarbital, primidone, repotrectinib, rifabutin, rifapentine, sotorasib, St John's Wort\n* Cirrhosis\n* GCS \\\u003C 14\n* Rhabdomyolysis (CPK \\> 5,000 U\u002FL)\n* Chronic opioid use (\\>30mg OME\u002Fday)\n* Known or suspected active infection with human immunodeficiency virus or hepatitis B or C viruses",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":13,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"Orange","California","92868","United States",{"lat":100,"lon":101},33.78779,-117.85311,[],[],[105,109,112,115,118,121,124,127,130],{"pmid":106,"type":107,"citation":108},"27533913","BACKGROUND","Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097\u002FTA.0000000000001209.",{"pmid":110,"type":107,"citation":111},"15086666","Stawicki SP, Grossman MD, Hoey BA, Miller DL, Reed JF 3rd. Rib fractures in the elderly: a marker of injury severity. J Am Geriatr Soc. 2004 May;52(5):805-8. doi: 10.1111\u002Fj.1532-5415.2004.52223.x.",{"pmid":113,"type":107,"citation":114},"10866248","Bulger EM, Arneson MA, Mock CN, Jurkovich GJ. Rib fractures in the elderly. J Trauma. 2000 Jun;48(6):1040-6; discussion 1046-7. doi: 10.1097\u002F00005373-200006000-00007.",{"pmid":116,"type":107,"citation":117},"30376537","Carver TW, Kugler NW, Juul J, Peppard WJ, Drescher KM, Somberg LB, Szabo A, Yin Z, Paul JS. Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. J Trauma Acute Care Surg. 2019 Feb;86(2):181-188. doi: 10.1097\u002FTA.0000000000002103.",{"pmid":119,"type":107,"citation":120},"23706726","Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016\u002Fj.pain.2013.03.029. Epub 2013 Mar 27.",{"pmid":122,"type":107,"citation":123},"29149140","Peng K, Zhang J, Meng XW, Liu HY, Ji FH. Optimization of Postoperative Intravenous Patient-Controlled Analgesia with Opioid-Dexmedetomidine Combinations: An Updated Meta-Analysis with Trial Sequential Analysis of Randomized Controlled Trials. Pain Physician. 2017 Nov;20(7):569-596.",{"pmid":125,"type":107,"citation":126},"27812971","Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007\u002Fs40261-016-0477-9.",{"pmid":128,"type":107,"citation":129},"19934395","Gerlach AT, Murphy CV, Dasta JF. An updated focused review of dexmedetomidine in adults. Ann Pharmacother. 2009 Dec;43(12):2064-74. doi: 10.1345\u002Faph.1M310.",{"pmid":131,"type":107,"citation":132},"16269301","Flagel BT, Luchette FA, Reed RL, Esposito TJ, Davis KA, Santaniello JM, Gamelli RL. Half-a-dozen ribs: the breakpoint for mortality. Surgery. 2005 Oct;138(4):717-23; discussion 723-5. doi: 10.1016\u002Fj.surg.2005.07.022.",[],{"nct_id":4,"conditions":135,"biomarkers":137},[136],"Rib Fracture",[],{"nct_id":4,"found":68,"summary":67,"prompt_version":67}]