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NCT Number: NCT07821931

Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management

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.

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Key information

Conditions

Tonsillectomy Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Pharyngoplasty Postoperative Complications Postoperative Pain Signs and Symptoms Suzetrigine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Palo Alto, California, 94304, United States

Location contact

Jonathan B Lee, MD

SUB_INVESTIGATOR

Pedro Martins Gomes de Oliveira, MD

SUB_INVESTIGATOR

Robson Capasso, MD

SUB_INVESTIGATOR

Sophia Chen, MD

SUB_INVESTIGATOR

Uchechukwu Megwalu, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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).

Acetaminophen

Drug

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

Oxycodone

Drug

Oxycodone 5-10 mg every 4-6 hours

Primary outcomes

Opioid Consumption (Total MME consumed)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

STOP Trial (Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management)

Acronym: STOP

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 16, 2026
Registry last updated: Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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