Acute Pain, Opioid, Pharyngoplasty, Postoperative Pain, Suzetrigine, Tonsillectomy
Conditions
Keywords
Tonsillectomy, Pharyngoplasty, Suzetrigine, Nav1.8, Postoperative pain, Acute pain, Pain, Pain, Postoperative, Analgesics, Non-Narcotic, Analgesics, Opioid, Voltage-Gated Sodium Channel Blockers, NAV1.8 Voltage-Gated Sodium Channel, Pain Management, Otorhinolaryngologic Surgical Procedures, Opioid-sparing analgesia
Brief summary
The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine can lower how much opioid pain medicine adults need after tonsil surgery (tonsillectomy) or a similar throat surgery.
Interventions
DRUGSuzetrigine
Suzetrigine is administered at its FDA-approved dose for moderate-to-severe acute pain: a 100 mg oral loading dose followed by 50 mg orally every 12 hours. No dose modification, dose escalation, or novel route is used; the trial therefore does not involve a dosage level or route that would increase risk relative to approved labeling, which is one of the conditions supporting IND exemption under 21 CFR 312.2(b).
DRUGAcetaminophen
Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)
DRUGoxycodone
Oxycodone 5-10 mg every 4-6 hours
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty \[UPPP\], expansion sphincter pharyngoplasty \[ESP\]) by a study investigator. 2. Able to understand the consent discussion in English by telephone, provide informed consent, and comply with study procedures, including completion of electronic patient-reported outcome surveys. 3. Willing and able to complete daily electronic (text message and/or email) pain surveys for 14 days and to return the dispensed opioid bottle for pill count or to respond to a telephone pill-count contact.
Exclusion criteria
1. Chronic opioid use 2. Significant hepatic disease 3. Pregnant or breastfeeding. 4. Known allergy or intolerance to any study medication 5. Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity. 6. Current use of a strong CYP3A4 inhibitor 7. Use of hormonal birth control and unwilling to receive suzetrigine-related counseling, given that suzetrigine may reduce hormonal contraceptive efficacy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption (Total MME consumed) | From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively | Total opioid consumption (morphine milliequivalents - MME) from postoperative day (POD) 0 through POD 14, determined by returned-pill count of dispensed oxycodone. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTristan Tham, MD
Stanford University
Outcome results
None listed