RCT: Suzetrigine vs Norco for Post-op Pain

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 critical period can lead to impaired function, slower healing, and may be a factor in prolonged pain in the subacute setting4. Despite the critical importance of effective postoperative pain control to patient recovery, the optimal analgesic approach remains a topic of debate, with both opioid and non-opioid medications utilized in clinical practice5,6.

Opioids have long played a central role in managing postoperative pain in oral surgery7. The risks associated with opioid use are well-documented7,8. Addiction and misuse are the most widely discussed opioid side effects in the public. However, more common side effects, such as nausea, vomiting, constipation, respiratory depression, and sedation, can have a profound effect on morbidity. Furthermore, there is a growing body of evidence suggesting that the overprescription of opioids following common procedures like wisdom tooth extraction contributes to the larger opioid epidemic8. These risks underscore the need for alternative pain management strategies that minimize or eliminate the need for opioids.

Journavx (suzetrigine) is a novel non-opioid analgesic that offers a promising alternative for managing postoperative pain9,10. Suzetrigine is selective inhibitor of the sodium channel NaV1.8, for managing acute pain. NaV1.8, a sodium channel subtype found primarily in peripheral nerves and dorsal root ganglia, plays a key role in transmitting nociceptive signals. Importantly, this channel is minimally expressed in the brain, enabling selective blockade to provide targeted, effective analgesia without the potential central nervous system side effects of respiratory depression and addiction associated with opioids11. Clinical trials have shown Journavx to be effective in managing moderate to severe post-operative pain equal to that of opiates11. This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery.

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, cannot receive instruction in English, are currently utilizing analgesics for another painful condition