Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of back pain. A total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from April 2024 - April 2025. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 34 participants to evaluate for effectiveness and power
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
- •Age 18 - 65 years old
- •Presenting to the Bronson ED with a chief complaint of acute, non-traumatic back pain
- •VAS score >5 cm
排除标准
- •Back pain due to traumatic injury
- •Experiencing saddle anesthesia
- •Has bowel or bladder dysfunction
- •Has an abnormal neurological exam
- •Requires imaging in ED
- •Has a Glascow coma score <15
- •Has one or more abnormal vital signs:
- •HR>120, SBP>180 or <90, temperature >38°, O2 saturation<92%
- •Has an allergy to ketorolac or haloperidol
- •Has a known diagnosis of Lewy Body Dementia
- •Has a known diagnosis of glaucoma.
- •Is known to be pregnant or breastfeeding
- •Is a prisoner or ward of the state
- •Is unable to consent for themselves/ non-english speaking
- •In the opinion of the attending physician or investigator the patient should not participate in the research
研究组 & 干预措施
Haloperidol
Haloperidol 5 mg IM haloperidol
干预措施: Haloperidol (Drug)
Ketoralac
Ketoralac 30 mg IM
干预措施: Ketorolac Tromethamine (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 30, 60, and 90 minutes after drug administration
Mean change in visual analog scale (VAS) of self-rated nausea severity
次要结局
- Length of stay after enrollment(24 hours)
- Patient Satisfaction(24 hours after enrollment up to 1 week)
- Need for rescue medications(30, 60, and 90 minutes after drug administration)