Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management

NCT07821931 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 88536
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy; Pharyngoplasty; Suzetrigine; Opioid; Postoperative Pain; Acute Pain

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

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption (Total MME consumed)

  Total opioid consumption (morphine milliequivalents - MME) from postoperative day (POD) 0 through POD 14, determined by returned-pill count of dispensed oxycodone.

  From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively

Study Arms (2)

Suzetrigine (100-50mg)

EXPERIMENTAL

Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain plus suzetrigine (100mg loading dose followed by q12 50mg PO) up to two weeks.

Drug: Suzetrigine; Drug: Acetaminophen; Drug: oxycodone

Standard of care

ACTIVE COMPARATOR

Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks.

Drug: Acetaminophen; Drug: oxycodone

Interventions

Suzetrigine DRUG

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).

Suzetrigine (100-50mg)

Acetaminophen DRUG

Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)

Standard of care; Suzetrigine (100-50mg)

oxycodone DRUG

Oxycodone 5-10 mg every 4-6 hours

Standard of care; Suzetrigine (100-50mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty \[UPPP\], expansion sphincter pharyngoplasty \[ESP\]) by a study investigator.
• 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.
• 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.

You may not qualify if:

• Chronic opioid use
• Significant hepatic disease
• Pregnant or breastfeeding.
• Known allergy or intolerance to any study medication
• Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity.
• Current use of a strong CYP3A4 inhibitor
• Use of hormonal birth control and unwilling to receive suzetrigine-related counseling, given that suzetrigine may reduce hormonal contraceptive efficacy.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (2)

• Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.

  PMID: 37530822 BACKGROUND

• Osteen JD, Immani S, Tapley TL, Indersmitten T, Hurst NW, Healey T, Aertgeerts K, Negulescu PA, Lechner SM. Pharmacology and Mechanism of Action of Suzetrigine, a Potent and Selective NaV1.8 Pain Signal Inhibitor for the Treatment of Moderate to Severe Pain. Pain Ther. 2025 Apr;14(2):655-674. doi: 10.1007/s40122-024-00697-0. Epub 2025 Jan 8.

  PMID: 39775738 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Pain; Agnosia

Interventions

Acetaminophen; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Tristan Tham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)