STOP Trial (Suzetrigine in Tonsillectomy for Opioid-sparing Pain Management)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Opioid Consumption (Total MME consumed)
研究概览
简要总结
The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine can lower how much opioid pain medicine adults need after tonsil surgery (tonsillectomy) or a similar throat surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo tonsillectomy or a variant pharyngeal procedure (e.g., palatoplasty, uvulopalatopharyngoplasty [UPPP], expansion sphincter pharyngoplasty [ESP]) by a study investigator.
- •Able to understand the consent discussion in English by telephone, provide informed consent, and comply with study procedures, including completion of electronic patient-reported outcome surveys.
- •Willing and able to complete daily electronic (text message and/or email) pain surveys for 14 days and to return the dispensed opioid bottle for pill count or to respond to a telephone pill-count contact.
排除标准
- •Chronic opioid use
- •Significant hepatic disease
- •Pregnant or breastfeeding.
- •Known allergy or intolerance to any study medication
- •Unable to complete patient-reported outcome measures because of language barrier, literacy, or infirmity.
- •Current use of a strong CYP3A4 inhibitor
- •Use of hormonal birth control and unwilling to receive suzetrigine-related counseling, given that suzetrigine may reduce hormonal contraceptive efficacy.
研究组 & 干预措施
Suzetrigine (100-50mg)
Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain plus suzetrigine (100mg loading dose followed by q12 50mg PO) up to two weeks.
干预措施: Suzetrigine (Drug)
Standard of care
Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks.
干预措施: oxycodone (Drug)
Standard of care
Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain up to two weeks.
干预措施: Acetaminophen (Drug)
Suzetrigine (100-50mg)
Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain plus suzetrigine (100mg loading dose followed by q12 50mg PO) up to two weeks.
干预措施: Acetaminophen (Drug)
Suzetrigine (100-50mg)
Participants will receive the standard of care medications (acetaminophen and oxycodone) for their post-operative course to manage their pain plus suzetrigine (100mg loading dose followed by q12 50mg PO) up to two weeks.
干预措施: oxycodone (Drug)
结局指标
主要结局
Opioid Consumption (Total MME consumed)
时间窗: From surgery (POD 0 ) up to 2 weeks (POD 14) post-operatively
Total opioid consumption (morphine milliequivalents - MME) from postoperative day (POD) 0 through POD 14, determined by returned-pill count of dispensed oxycodone.
次要结局
未报告次要终点
研究者
Tristan Mark Tham Yong-Ren
Assistant Professor of Otolaryngology - Head and Neck Surgery
Stanford University