A Randomized Controlled Trial Comparing Suzetrigine and Acetaminophen for Reducing Pain During Local Anesthetic Infiltration and Head Frame Application
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS-Anxiety) score
研究概览
简要总结
Local anesthetic infiltration is a primary source of acute pain during stereotactic procedures.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for a standard of care procedure requiring a stereotactic head frame to be placed
排除标准
- •Patients not scheduled for a standard of care procedure requiring a stereotactic head frame to be placed will not be approached
研究组 & 干预措施
Acetaminophen
acetaminophen (1000 mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
干预措施: acetaminophen (Drug)
Suzetrigine
Suzetrigine (100mg) - is self-administered at home on an empty stomach approximately 1-6 hours prior to the procedure.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Visual Analog Scale (VAS-Anxiety) score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Hour 6
Documentation of the total volume (mL) of local anesthetic infused.
次要结局
- Number of Clinically Significant Vasovagal Episodes(Hour 6)