Prehospital Analgesia INtervention Trial (PAIN)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Jason Sperry
- 入组人数
- 994
- 试验地点
- 19
- 主要终点
- 24-hour mortality
研究概览
简要总结
The Prehospital Analgesia INtervention trial (PAIN) is a proposed 4 year (3-year enrollment) multicenter, prehospital, randomized, double-blind, clinical trial that will enroll approximately 994 patients at select LITES Network sites. The objective is to perform a prospective, interventional, randomized trial among prehospital trauma patients with compensated shock (SI≥0.9 or HR ≥115) and an indication for pain management, comparing patient centered outcomes following prehospital administration of ketamine hydrochloride versus fentanyl citrate.
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
- Double (Participant, Care Provider)
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
- •Transport after injury to a participating PAIN Trauma center
- •2. Patient with compensated shock as defined by Shock Index (SI) ≥0.9 or Heart Rate (HR) ≥
- •Intravenous pain medication indicated (CPOT≥2, NRS≥5) prior to arrival at the trauma center
排除标准
- •No IV access
- •Age <18 years
- •Females <50 years of age
- •SBP>180 mmHg at time of enrollment
- •Advanced airway management prior to first dose administration
- •Known allergy to fentanyl citrate or ketamine hydrochloride
- •Known prisoner
- •Objection to study voiced by subject or family member at scene
- •Pain treatment contraindicated by local protocol
- •Wearing a "NO PAIN STUDY" bracelet
研究组 & 干预措施
Ketamine Hydrochloride
2 blinded doses 2.5mg/ml ketamine hydrochloride in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.
干预措施: Ketamine Hydrochloride (Drug)
Fentanyl Citrate
2 blinded doses 10mcg/ml in separately sealed pre-filled syringes Subjects will be administered the first dose over approximately 2 minutes via slow IV push. Pain assessment following administration will be obtained and recorded every 15 minutes. Redosing may occur after approximately 15 minutes if the subject has a qualifying pain score, there are no contraindications to pain medication per local protocol, and no exclusion criteria have been met.
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
24-hour mortality
时间窗: trauma bay arrival through 24 hours
All cause mortality within 24 hours from time of trauma bay arrival
次要结局
- Hypotension(from initial administration of PAIN study prehospital analgesia through hospital arrival)
- Need for airway management(from initial administration of PAIN study prehospital analgesia through hospital arrival)
- Number of analgesic doses necessary to reduce pain level to <5 NRS or CPOT less than 2(from initial administration of PAIN study prehospital analgesia through hospital arrival)
- Prehospital pain assessment following analgesia(from initial administration of PAIN study prehospital analgesia through hospital arrival)
- Hospital length of stay(from time of hospital admission to discharge)
- Hypoxia(from initial administration of PAIN prehospital analgesia through hospital arrival)
- Trauma bay arrival pain score(score assessed at time of arrival to trauma bay)
- Survival to hospital discharge(administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days)
- Ventilator free days(from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days)
- Long term opioid use(3 months (+/- 1 month) and 6 months (+/- 1 month) following trauma admission)
- 24 hour opioid use(from initial administration of PAIN study prehospital analgesia through 24 hours)
- Incidence of prehospital adverse events(from initial administration of PAIN study prehospital analgesia through hospital arrival)
- Baseline Pain/Anxiety/PTSD screening(0 hours to 2 weeks from time of hospital admission)
- Intensive Care Unit free days(from administration of PAIN study prehospital analgesia through hospital discharge or death up to 30 days)
- Long term (6 month) outcome(6 months +/- 1 month following trauma admission)
- Long Term Pain Assessment(At 3 and 6 months (+/- 1 month) after hospital arrival)