Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Chronic opioid use
Significant hepatic disease
Pregnant or breastfeeding.
Known allergy or intolerance to any study medication
Trial design
Design model
Parallel
Treatments tested in this trial
Suzetrigine
DrugSuzetrigine 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
DrugAcetaminophen 1,000 mg every 6 hours (maximum 4,000 mg/24 h)
oxycodone
DrugOxycodone 5-10 mg every 4-6 hours
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Suzetrigine (100-50mg)Experimental treatment 3 interventions
Group B: Standard of careActive comparator 2 interventions
Trial outcomes
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.
Time frame
From surgery (POD 0 ) up to 2 weeks (POD 14) post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: