Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain. A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Change in 0-10 Pain Scale Between Baseline and 90 Minutes
研究概览
简要总结
This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.
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)
盲法说明
Double-blind
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
- •Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.
排除标准
- •Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg will be excluded.
研究组 & 干预措施
Intravenous hydromorphone
Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.
干预措施: Hydromorphone (Drug)
Intravenous lidocaine
Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
干预措施: Lidocaine (Drug)
结局指标
主要结局
Change in 0-10 Pain Scale Between Baseline and 90 Minutes
时间窗: up to 90 minutes
Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable
次要结局
- Rescue Medication(4 hours)
- Adverse Events(4 hours)
研究者
Benjamin W. Friedman, MD
Professor
Montefiore Medical Center