Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management

Phase 4Not Yet RecruitingNCT07821931

Stanford University58 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tonsillectomy Pharyngoplasty Suzetrigine Opioid Postoperative Pain Acute Pain

Interventions

SuzetrigineDRUG

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).

AcetaminophenDRUG

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

oxycodoneDRUG

Oxycodone 5-10 mg every 4-6 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

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.

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

Data from ClinicalTrials.gov

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