Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Pain Severity in the Emergency Department: Numeric Rating Scale
研究概览
简要总结
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period after discharge. The investigators will compare the lorazepam arm to a placebo arm.
详细描述
The investigators will enroll 120 medically stable adult patients who present to two emergency departments with a physical injury (< 24 hours ago) and a chief complaint of pain.
The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department providers and patients will be blind to treatment allocation.
All participants will complete measures of negative affect and pain scores at baseline, and and 1 and 2 hours post-study drug administration. The investigators will record any analgesics administered in the emergency department until discharge. Patients will also undergo quantitative sensory testing in the Emergency Department at baseline, and after study drug administration. At 14-days post-discharge, the investigators will measure summary reports of pain, mood, and analgesic medication used.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 18-65
- •Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale [NRS] from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"
- •Expected to be in the ED for at least 2 hours, in a private treatment room
- •Ownership of a cell phone with text messaging capabilities
- •Emergency Department admission assessment confirmed subject is not suicidal.
排除标准
- •Non-English speaking
- •Not medically suitable for lorazepam per treating MD (e.g. medical condition where benzodiazepines are contraindicated or may be unsafe)
- •Not alert and oriented
- •Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- •Seeking treatment due to a mental health or substance use disorder
- •History of chronic opioid use
- •Prescribed opioid or benzodiazepine use within the past 24 hours
- •Alcohol use within the past 12 hours or medical history of alcoholism.
- •Clinical indication for open-label benzodiazepine administration in the ED.
- •Any use of recreational narcotics throughout lifetime
- •Sensitivity or allergy or intolerance to opioids or benzodiazepines
- •Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
研究组 & 干预措施
Drug: Oral Lorazepam (1mg)
Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
干预措施: Lorazepam (Drug)
Drug: Oral Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Pain Severity in the Emergency Department: Numeric Rating Scale
时间窗: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
次要结局
- Negative Affect in the Emergency Department(The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.)
研究者
Maria Pacella
Research Assistant Professor
University of Pittsburgh