Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen
ConditionAnalgesic Efficacy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorWake Forest University Health Sciences
About this trial
Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed
Disqualifiers
Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached
Trial design
Design model
Parallel
Treatments tested in this trial
Suzetrigine
Drug100mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
acetaminophen
Drug1000mg - Medication is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: AcetaminophenActive comparator 1 intervention
Group B: SuzetrigineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS-Anxiety) score
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).
Time frame
Baseline2
Visual Analog Scale (VAS-Infiltration) score
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).
Time frame
Baseline3
Visual Analog Scale (VAS-Pin Tightening) score
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).
Time frame
Baseline4
Visual Analog Scale (VAS-Anxiety Reassessment) score
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).
Time frame
Hour 24Secondary outcomes
1
Number of Clinically Significant Vasovagal Episodes
Documentation of any vasovagal response characterized by loss of color, sweating, and/or nausea that requires rescue via raising the patient's legs to a height higher than their head.
Time frame
Hour 6Sponsors and contacts
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Source ClinicalTrials.gov