Intravenous Lidocaine Versus Provider Chosen Dose of Morphine for the Treatment of Severe Pain in the Emergency Department: An Open-label Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain Score (NRS 0-10)
研究概览
简要总结
Objective: Evaluate the analgesic efficacy of intravenous (IV) lidocaine versus provider chosen dose of IV morphine for the treatment of severe pain in the emergency department.
Study design: Open-label, randomized controlled pilot study.
详细描述
Objective
The purpose of this pilot study is to determine the analgesic efficacy of intravenous lidocaine versus morphine for the treatment of severe pain in the emergency department (ED).
Study design: Open-label, randomized, controlled pilot trial. Participants: Investigators and research assistants will recruit patients ≥18 years old with severe pain (NRS ≥7) and an anticipated stay in the emergency department ≥1 hour. A sample size calculation was performed and 32 patients will be enrolled.
Intervention: After a trained research assistant obtains written informed consent, eligible participants will be randomized to the intravenous lidocaine or morphine arms of the study. In the intravenous lidocaine arm, patients will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg). In the morphine arm, the ED provider will choose an appropriate dose of morphine for the patient. At 20 and 40 minutes, the participants will be asked "Would you like additional pain medication?". Participants responding in the affirmative will receive morphine 4 mg IV.
Data collection: The trained research assistant will collect data on the patients' pain scores, side effects, and rescue morphine.
Statistical analysis
Investigators will perform descriptive statistics and compare pain scores and pain relief at each time point with unpaired t-tests.
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
- None
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
- •Subject has severe pain (NRS ≥7)
- •Subject has anticipated ED stay of ≥1 hour
排除标准
- •High acuity trauma patients
- •Patients deemed to critically ill by ED provider
- •Active psychosis
- •Pregnancy
- •History of heart block or bradycardia
- •Allergy to lidocaine or amide type local anesthetic
- •History of seizures
研究组 & 干预措施
Intravenous lidocaine
Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.
At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.
干预措施: Intravenous lidocaine (Drug)
Morphine
ED provider will choose an appropriate dose of intravenous morphine for the patient.
At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.
干预措施: Intravenous morphine (Drug)
结局指标
主要结局
Pain Score (NRS 0-10)
时间窗: At 60 minutes
Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.
次要结局
- Pain Relief at 40 Minutes Compared to Baseline.(At 40 minutes)
- Number of Participants Requiring Rescue Medications(At 20 and 40 minutes)
- Pain Relief at 10 Minutes Compared to Baseline.(At 10 minutes)
- Pain Relief at 20 Minutes Compared to Baseline.(at 20 minutes)
- Pain Relief at 50 Minutes Compared to Baseline.(At 50 minutes)
- Pain Score (NRS 0-10)(At 50 minutes)
- Pain Relief at 60 Minutes Compared to Baseline.(At 60 minutes)
- Pain Relief at 30 Minutes Compared to Baseline.(at 30 minutes)
- Patient Satisfaction(60 minutes)
- Number of Participants Reporting Adverse Events(0-60 minutes)
研究者
Eben Clattenburg
Principle Investigator
Alameda Health System