Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suzetrigine, acetaminophen.
- Who it may be relevant to
- Registry conditions: Analgesic Efficacy. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application
Overview
Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.
Detailed description
Frame placement can be painful even with local numbing medicine. This study compares two oral medications-Suzetrigine (an FDA-approved (January 30, 2025) non-opioid, non-addictive medication used to treat moderate-to-severe acute pain in adults)) and acetaminophen (Tylenol)-to see which is more effective at reducing this pain. Both Tylenol and Suzetrigine are currently being used for pain prevention during head frame placement. This study is being conducted to determine if one offers greater relief than the other.
Interventions
- Drug Suzetrigine
100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure. - Drug acetaminophen
1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
Primary outcome measures
- Visual Analog Scale (VAS-Anxiety) score [Time frame: Baseline]
- Visual Analog Scale (VAS-Infiltration) score [Time frame: Baseline]
- Visual Analog Scale (VAS-Pin Tightening) score [Time frame: Baseline]
- Visual Analog Scale (VAS-Anxiety Reassessment) score [Time frame: Hour 24]
- Total Anesthetic Volume [Time frame: Hour 6]
Secondary outcome measures (1)
- Number of Clinically Significant Vasovagal Episodes [Time frame: Hour 6]
Eligibility criteria
Inclusion criteria
- Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed
Exclusion criteria
- Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT07525219 · IRB00146434