RCT: Suzetrigine vs Norco for Post-op Pain
NCT07195669 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2025-09-29
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.
Conditions
- Pain Control
Interventions
- DRUG
-
Suzetrigine (SUZ)
Used in the course of acute post-operative pain following oral and maxillofacial surgeries
- DRUG
-
Norco
Its standard of care
Sponsors & Collaborators
-
Jacob Lensing
lead OTHER
Principal Investigators
-
Jacob Lensing, DDS · LSUHSC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-01
- Primary Completion
- 2025-12-30
- Completion
- 2026-01-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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