An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Clinical Improvement in NRS Pain Score
研究概览
简要总结
Intravenous opioids are the mainstay of acute, severe pain treatment in Emergency Departments (ED) across the country. Acetaminophen, given orally, has also been used for treatment of mild to moderate pain. The more potent intravenous (IV) form of acetaminophen has been widely used in Europe for more than 20 years as post-surgical analgesia and received full FDA approval in the USA in 2010. As part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ED patients, this randomized study will compare efficacy and safety of IV acetaminophen to IV hydromorphone.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age equal to 65 or greater
- •Pain onset within 7 days with severe pain
- •Has capacity to provide informed consent
- •Understanding English or Spanish
排除标准
- •Use of tramadol or opioids within 7 days
- •Use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours
- •Chronic pain syndrome: daily pain for > 3 months. Sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies
- •Conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (Child Pugh A or worse), kidney impairment (CKD 3 or worse), active hepatic disease or severe dehydration
- •Alcohol intoxication
- •Systolic blood pressure: < 100 mmHg
- •Heart rate: < 60 beats per minute
- •Oxygen saturation: < 95% on room air
- •Use of monoamine oxidase (MAO) inhibitors in the past 30 days
- •Use of transdermal pain patch or oral opioid > 10 days in the prior month
- •Prior enrollment in the same study
研究组 & 干预措施
Acetaminophen 1000mg IV
NRS pain score will be obtained at baseline, 15, 30, 45, 60, 90, 120, and 180 minutes following completion of intervention. Adverse events will be recorded every 15 minutes for the duration of the study protocol. Participants will be reassessed for the need of additional pain control at 60 minutes.
干预措施: Acetaminophen 1000mg IV (Drug)
Hydromorphone 0.5mg IV
NRS pain score will be checked at 5 minutes and every 15 minutes thereafter for 120 minutes. Adverse events will be recorded every 15 minutes for the duration of the study protocol. The need for additional pain control will be assessed at 60 minutes.
干预措施: Hydromorphone 0.5 mg IV (Drug)
结局指标
主要结局
Clinical Improvement in NRS Pain Score
时间窗: 60 minutes following administration of medication
Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning "no pain" and 10 meaning "the worst pain imaginable." Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of \>=1.3 points on the 0-10 scale.
次要结局
- Need for Rescue Medication(120 minutes following administration of medication)
- Improvement in NPS Pain Score by >=50%(60 minutes after administration of medication)