Nonopioid Versus Opioid Management of Post-operative Pain Following Oral & Maxillofacial Surgery: A Randomized Controlled Trial
Jacob Lensing
Summary
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. Participants 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.
Description
Every year millions of oral and maxillofacial surgical procedures are performed globally, with patients frequently experiencing significant postoperative pain that can persist long after hospital discharge1. One of the most frequent outpatient procedures performed by oral surgeons is third molar extraction, with an estimated 10 million such procedures performed annually in the United States alone2. Orthognathic surgery, another common procedure, has been reported to have the highest postoperative pain scores compared to other oral and maxillofacial procedures3. Inadequate pain control in this…
Eligibility
- Age range
- 18–45 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Patients aged 18-45 years undergoing bimaxillary orthognathic surgery. Exclusion Criteria: * 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, c…
Interventions
- DrugSuzetrigine (SUZ)
Used in the course of acute post-operative pain following oral and maxillofacial surgeries
- DrugNorco
Its standard of care
Location
- LSU Dental SchoolNew Orleans, Louisiana