Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
研究概览
简要总结
To determine the efficacy of intravenous (IV) acetaminophen as an analgesic adjunct to IV hydromorphone in the treatment of acute severe pain in the elderly Emergency Department (ED) patients.
详细描述
A randomized controlled trial to determine the efficacy of 1 gram IV acetaminophen as an analgesic adjunct to 0.5 mg IV hydromorphone in the treatment of acute severe pain in the elderly ED patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician
排除标准
- •Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
- •Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
- •Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
- •Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
- •Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
- •Heart Rate (HR) < 60/min: Opioids can cause bradycardia.
- •Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
- •Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
- •Patients using transdermal pain patches
研究组 & 干预措施
IV acetaminophen + 0.5 mg IV hydromorphone
1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone
干预措施: IV acetaminophen + 0.5 mg IV hydromorphone (Drug)
Normal saline + 0.5 mg IV hydromorphone
100 ml normal saline placebo in addition to 0.5 mg IV hydromorphone
干预措施: Normal saline + 0.5 mg IV hydromorphone (Drug)
结局指标
主要结局
Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
时间窗: baseline and 60 minutes after medication was infused
Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline \[e.g. Change = NRS(baseline) - NRS(60 min)\]. Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given.
次要结局
- Change in Pain Intensity Over Time(baseline to 5 min, 15 min, 30 min, and 45 minutes)
研究者
Andrew Chang, MD
Professor of Emergency Medicine
Albany Medical College