Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of ropivacaine and hydrocodone for nail-procedure associated pain management. The investigators hypothesize that ropivacaine with hydrocodone will be superior to ropivacaine with acetaminophen and ibuprofen for managing pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing fingernail or toenail, excision, or shave biopsy
- •Must understand and voluntarily sign an informed consent form
- •Must be male or female and aged 18-95 years at time of consent
- •Must be able to adhere to the study visit schedule and other protocol requirements
排除标准
- •Subject is unable to provide written informed consent for any reason
- •Subject has peripheral vascular disease, arterial insufficiency, peripheral neuropathy
- •Subject is on Aspirin, NSAIDs, or consumes a chronic medication for control of any other chronic pain
- •Subject has a history of opioid or alcohol use disorder
- •Subject has a history of peptic ulcer disease, gastritis, chronic renal insufficiency or a history of kidney disease, or has underlying liver disease
- •Subject has a history of severe constipation
- •Subject is sensitive or allergic to any of the elements included in this study
- •Subject is unable to complete the required pain dairy
- •Subject is pregnant, planning pregnancy, or nursing
研究组 & 干预措施
Hydrocodone 5mg/acetaminophen 325mg
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
干预措施: Hydrocodone 5Mg/Acetaminophen 325Mg Tab (Drug)
Hydrocodone 5mg/acetaminophen 325mg
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
干预措施: Acetaminophen 1000mg (Drug)
Hydrocodone 5mg/acetaminophen 325mg
Participants receive oral hydrocodone 5 mg/acetaminophen 325 mg every 4 hours for 2 days, followed by oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 4 days
干预措施: Ibuprofen 400 mg (Drug)
Acetaminophen 1000mg + Ibuprofen 400mg
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
干预措施: Acetaminophen 1000mg (Drug)
Acetaminophen 1000mg + Ibuprofen 400mg
Participants receive oral acetaminophen 1000 mg and oral ibuprofen 400 mg every 6 hours for 6 days
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
时间窗: Baseline, 2 days
Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain.
次要结局
- Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire(3 days, 6 days (end of study))