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

September 10, 2026 updated by: Tristan Mark Tham Yong-Ren, Stanford University

STOP Trial (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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
        • Sub-Investigator:
          • Pedro Martins Gomes de Oliveira, MD
        • Sub-Investigator:
          • Uchechukwu Megwalu, MD
        • Sub-Investigator:
          • Robson Capasso, MD
        • Sub-Investigator:
          • Jonathan B Lee, MD
        • Sub-Investigator:
          • Sophia Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suzetrigine (100-50mg)
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
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).
Drug: Acetaminophen
Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)
Drug: oxycodone
Oxycodone 5-10 mg every 4-6 hours
Active Comparator: Standard of care
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
Acetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)
Drug: oxycodone
Oxycodone 5-10 mg every 4-6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Tristan Tham, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe