[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607985":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Louisiana State University Health Sciences Center in New Orleans","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Suzetrigine + Ibuprofen","EXPERIMENTAL","\\- Group 1 will receive a 100-mg oral loading dose of Journavx (suzetrigine), followed by a 50-mg maintenance dose every 12 hours (the high-dose group) and ibuprofen 800 mg q8h for 72 hours after surgery (1).",[13],"Drug: Suzetrigine (SUZ)",{"label":15,"type":16,"description":17,"interventionNames":18},"Opioid + Ibuprofen","ACTIVE_COMPARATOR","\\- Group 2 will receive ibuprofen 800 mg x 15 tabs q8h scheduled and hydrocodone\u002Facetaminophen 5\u002F325 q8h PRN for 72 hours after surgery. Patients will be informed not to exceed 3g of acetaminophen or 3200 mg ibuprofen (1).",[19],"Drug: Norco",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Suzetrigine (SUZ)","Used in the course of acute post-operative pain following oral and maxillofacial surgeries",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Norco","Its standard of care",[15],[32],{"name":33,"affiliation":34,"role":35},"Jacob Lensing, DDS","LSUHSC","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Jacob N Lensing, DDS","CONTACT","641-780-0290","jlensi@lsuhsc.edu",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"James Vegryzn, DDS, MD","630-962-4605","jlensing96@gmail.com",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"LSU Dental School","New Orleans","Louisiana","70214","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-90.07507,29.95465,{"lat":58,"lon":57},[61,62,65],{"name":33,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":63,"role":39,"phone":44,"phoneExt":26,"email":64},"James Vegrzyn, DDS, MD","jvergrz@lsuhsc.edu",{"name":66,"role":35,"phone":26,"phoneExt":26,"email":26},"Jacob Lensing, dds",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Jacob Lensing","Resident","100607985","phase-4-rct-suzetrigine-vs-norco-for-post-op-pain-100607985",false,"NCT07195669","RCT: Suzetrigine vs Norco for Post-op Pain","Nonopioid Versus Opioid Management of Post-operative Pain Following Oral & Maxillofacial Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18-45 years requiring extraction of impacted mandibular bilateral third molar teeth, uncomplicated mesioangular impacted teeth, or vertical impaction of unerupted and impacted mandibular third molars.\n* Patients aged 18-45 years undergoing bimaxillary orthognathic surgery.\n\nExclusion Criteria:\n\n* Pregnant or nursing, history of prior opioid abuse, have history of temporomandibular dysfunction or local myofascial pain disorder preoperatively, with history of congenital syndrome requiring previous surgeries, orthognathic revisions, have a bleeding disorder, cannot receive instruction in English, are currently utilizing analgesics for another painful condition","ALL","18 Years","45 Years",{"count":82,"type":83},76,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Journavx (suzetrigine) is a novel non-opioid analgesic that is FDA approved for acute pain management and may offer a promising alternative for managing postoperative pain. Suzetrigine is selective inhibitor of the sodium channel NaV1.8, for managing acute pain. NaV1.8, a sodium channel, plays a key role in transmitting pain signals. Importantly, this channel is minimally expressed in the brain, enabling effective pain control without the potential central nervous system side effects of respiratory depression and addiction associated with opioids. Clinical trials have shown Journavx to be effective in managing moderate to severe post-operative pain equal to that of opiates. This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery.\n\nParticipants in this study should be aged 18-45 without significant autoimmune diseases, chronic kidney disease, liver disease, chronic pain disorder including temporomandibular joint disorder, bleeding disorders, pregnant or nursing, undergoing either extraction of both lower third molars or orthognathic surgery of both the maxilla and mandible.",[89],"Pain Control",[91,92,93],"pain","analgesic","post-operative","NOT_YET_RECRUITING","2025-09-24",{"date":97,"type":98},"2025-09-29","ACTUAL",{"date":100,"type":83},"2025-10-01",{"date":102,"type":83},"2026-01-30",{"name":69,"class":6},1]