NCT04129086已完成4 期
Ketamine for Acute Pain After Trauma: KAPT Trial
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
研究概览
简要总结
The purpose of this study is to compare the effectiveness of Ketamine drip along with usual care and usual care alone on trauma patients and to longitudinally quantify the pain experience of patients during hospitalization.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult trauma patients
- •Admission to Shock Trauma ICU (STICU) or Surgical Intermediate Unit (SIMU)
- •Randomization within 6 hours of arrival
排除标准
- •Patient not expected to survive
- •Contraindications to ketamine Allergy, Poorly controlled hypertension, Cardiac arrhythmia disorders (including atrial fibrillation), congestive heart failure, unstable coronary artery disease or recent myocardial infarction( MI)(within 6 months), cirrhosis, seizure disorder, and for those patients with unknown medical history - median sternotomy scar, mechanism of injury is fall from standing, 65 years of age or older, any arrhythmia on EKD)
- •pregnancy
- •in police custody
- •history of dementia or movement disorder (i.e. Parkinson's)
研究组 & 干预措施
Ketamine plus Usual care
Experimental
干预措施: Ketamine plus usual care (Drug)
Usual care
Active Comparator
干预措施: Usual Care (Drug)
结局指标
主要结局
Average Daily Opioid Use as Measured by the Morphine Milligram Equivalents (MME) Per Day
时间窗: In-hospital days (up to 6 weeks post hospital admission)
次要结局
- Duration of Ketamine Drip(Hospital discharge (up to 6 weeks post hospital admission))
- Pain as Assessed by Score on the Numeric Rating Scale (NRS)(Hospital discharge (up to 6 weeks post hospital admission))
- Number of Patients Who Required Unplanned Admission to Intensive Care Unit During In-hospital Stay(Hospital discharge (up to 6 weeks post hospital admission))
- Use of Other Pain Control Adjuncts Including Regional Anesthesia and Lidocaine Patch(Hospital discharge (up to 6 weeks post hospital admission))
- ICU Free Days(Hospital discharge (up to 6 weeks post hospital admission))
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Current Health)(6 months post admission)
- Number of Patients That Showed Signs of Delirium During In-hospital Stay(Hospital discharge (up to 6 weeks post hospital admission))
- Initiation of Ketamine Drip(Hospital discharge (up to 6 weeks post hospital admission))
- Ventilator Free Days(Hospital discharge (up to 6 weeks post hospital admission))
- Number of Patients Discharged From the Hospital With an Opioid Prescription(Hospital discharge (up to 6 weeks post hospital admission))
- Number of Patients Who Continue to Use Opioids at 6 Months Post Admission(6 months post admission)
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Pain/Discomfort)(6 months post admission)
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Anxiety/Depression)(6 months post admission)
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Previous Experience)(6 months post admission)
- Number of Patients That Required Unplanned Intubation During In-hospital Stay(Hospital discharge (up to 6 weeks post hospital admission))
- Number of Patients Requesting to Discontinue Ketamine(Hospital discharge (up to 6 weeks post hospital admission))
- Pain as Assessed by Score on the Behavioral Pain Scale (BPS)(Hospital discharge (up to 6 weeks post hospital admission))
- Hospital Free Days(30 days post admission)
- Number of Patients Who Reported Continued Pain Continued Post-traumatic Pain at 6 Months Post Admission(6 months post admission)
- Post Traumatic Stress Disorder (PTSD) as Assessed by the PC-PTSD-5 Questionnaire(Hospital discharge (about 1 to 6 weeks after admission))
- Pain as Assessed by Average Score on the Defense and Veterans Pain Rating Scale (DVPRS)(From time of admission to time of discharge from hospital (about 1 to 6 weeks after admission))
- Risk of Future Opioid Abuse as Assessed by the Opioid Risk Tool (ORT)(Hospital discharge (about 1 to 6 weeks after admission))
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Mobility)(6 months post admission)
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Self-Care)(6 months post admission)
- Health Status as Assessed by the Euro-QOL EQ-5D-3L Questionnaire (Usual Activities)(6 months post admission)
研究者
John Andrew Harvin
Associate Professor of Surgery
The University of Texas Health Science Center, Houston
研究点 (1)
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