Randomized, Prospective, Open-label, Controlled Trial of 0.5% Bupivacaine Lower Cervical Intramuscular Injection vs IV Medications in Treatment of Non-Traumatic Headache in the Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual analog scale pain score 0-10
研究概览
简要总结
Headache is a frequent chief complaint among patients presenting to the Emergency Department (ED), accounting for 2.1 million visits annually in the United States. Often, individuals resort to ED care only after over-the-counter or home remedies have failed, leading to the predominant use of intravenous (IV) medications in the ED, including NSAIDs, triptans, neuroleptics, antiepileptics, and dopaminergic antagonists. Unfortunately, these pharmacologic treatments frequently induce side effects such as cognitive impairment, extrapyramidal reactions, and the potential for medication dependency. In the ED, patients frequently require concurrent administration of multiple systemic medications to achieve satisfactory pain relief, thereby elevating the risk associated with medication use. Despite these medication regimens, a significant portion of patients continue to experience inadequate pain relief. Consequently, the search for an optimal headache therapy-characterized by rapid and effective pain relief, long lasting results, minimal side effects, and allows for rapid ED patient turnover-continues to be a popular area of research in emergency medicine. The investigators plan to evaluate the use of 0.5% bupivacaine cervical IM injection at the c6-7 location for the treatment of non traumatic headaches using a non-inferiority design, randomized, prospective, open-label, controlled trial comparing it to physicians choice of intravenous medications in treatment of headache in the Emergency Department at North Florida Hospital.
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
- •Patient has to be able to provide own consent
- •English-speaking only
- •Non traumatic headache with VAS pain score of 5 or above out of 10
排除标准
- •traumatic headache
- •Confused patients
- •allergy to bupivacaine
- •infection over injection site
- •recent neck surgery
- •hemodynamically unstable
- •bleeding disorder
- •anticoagulation use
- •pregnant, lactating women
- •prisoners
研究组 & 干预措施
Intravenous medication
physicians choice of intravenous medication for headache treatment
干预措施: standard IV treatment for headache (Drug)
cervical IM injection
bilateral cervical injections of 0.5% bupivacaine into the paraspinous muscle at the c6-7 location
干预措施: 0.5% Bupivacaine HCl (Drug)
结局指标
主要结局
Visual analog scale pain score 0-10
时间窗: 24 hours
Pain score at 30 minutes and 24 hours after treatment. 0 being no pain and 10 being the worse pain possible.
次要结局
- Need for additional medications(24 hours)
- Emergency department length of stay(24 hours)
研究者
Zhengqiu Zhou
Faculty
HCA Florida North Florida Hospital
