Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen
ConditionAnalgesic Efficacy
Trial statusNot yet recruiting
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
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: