A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS-Anxiety) score
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Masking Description
Both suzetrigine and acetaminophen will be placed into identical opaque capsules. Suzetrigine capsules will be backfilled with an inert excipient to match the weight and sound of the acetaminophen capsules.
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Acetaminophen
acetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
Intervention: acetaminophen (Drug)
Suzetrigine
Suzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
Intervention: Suzetrigine (Drug)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS-Anxiety) score
Time Frame: Baseline
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Visual Analog Scale (VAS-Infiltration) score
Time Frame: Baseline
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Visual Analog Scale (VAS-Pin Tightening) score
Time Frame: Baseline
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Visual Analog Scale (VAS-Anxiety Reassessment) score
Time Frame: Hour 24
A single consolidated VAS score (0-10) representing the pain experienced during the administration of local anesthetic across all four pin sites. This VAS is administered immediately after the local anesthetic injections are completed. For anxiety-VAS cutoff value = 40: the VAS score is ≥40 in 81% of patients with anxiety (sensitivity); the VAS score is \<40 in 70% of patients without anxiety (specificity); 67% of patients with a VAS score ≥ 40 have anxiety (PPV); 82% of patients with a VAS score \<40 do not have anxiety (NPV).
Total Anesthetic Volume
Time Frame: Hour 6
Documentation of the total volume (mL) of local anesthetic infused.
Secondary Outcomes
- Number of Clinically Significant Vasovagal Episodes(Hour 6)