Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07821931
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Acute Pain
  • Opioid
  • Pharyngoplasty
  • Postoperative Pain
  • Suzetrigine
  • Tonsillectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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

Study Details

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.

Key Dates

First listed
Sep 16, 2026
Start date
Nov 30, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Opioid Consumption (Total MME consumed) [ Time Frame: From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
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 (SUB_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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