Oral Rapidly Dissolving Olanzapine for Acute Primary Headache in the Emergency Department Setting: A Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in Pain Scores Based on Patient Questionnaire
研究概览
简要总结
This trial is a prospective, randomized, feasibility trial with the primary aim of comparing how well oral rapidly dissolving olanzapine controls primary headache pain when compared to the current treatment strategies used in emergency departments which often require intravenous or intramuscular medications.
详细描述
Primary Question:
Does oral rapidly dissolving olanzapine provide efficacious analgesia in patients with acute headache of non-organic origin (primary headache) who come to the ED for abortive therapy when compared to current standard of care?
Secondary Aim:
Additionally, the study will aim to see if oral rapidly dissolving olanzapine decreases 1) duration of ED length of stay and 2) need for IV access when compared to the current standard of care.
This is a prospective, randomized, convenience sample, feasibility trial to test for non-inferiority of oral rapidly dissolving olanzapine versus current emergency department standard of care in providing symptomatic relief to patients presenting with primary headache.
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
盲法说明
Open label, not blinded, randomized 2-arm trial
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
- 是
入选标准
- •Adult patient between 18-65 years of age presenting to the emergency department with acute primary headache
- •Patient approved for inclusion by primary attending physician in the emergency department
排除标准
- •Age < 18 or > 65
- •Known allergy to olanzapine
- •Known QT prolongation or underlying condition that places patient at risk for QT prolongation
- •Inability to give written consent (intoxication, altered mental status)
- •Headache of organic origin (trauma, infection, previous recent head or neck surgery)
- •Patient already prescribed daily olanzapine on an outpatient basis
- •Patient has been administered olanzapine within the past 24 hours
- •Language barrier
研究组 & 干预措施
Standard of Care
IV Morphine or any medication per attending decision
干预措施: Standard of Care as per attending physician (Drug)
Olanzapine
oral rapidly dissolving olanzapine (Zydis) 5 mg for analgesia in acute primary headaches.
干预措施: 5mg rapidly dissolving olanzapine (Drug)
结局指标
主要结局
Change in Pain Scores Based on Patient Questionnaire
时间窗: baseline, 30, 60, and 90 minutes post drug administration
Change in patient reported pain score from baseline using the Numeric Pain Rating Scale (PNRS) Minimum score = 0 Maximum score = 10 Lower score indicates lower pain level, with zero indicating no pain and 10 indicating the worst pain imaginable.
次要结局
- Comparison of Duration of ED Length of Stay(Length of Emergency Department stay (Time Frame: up to 12 hours))
- Number of Participants That Receive Peripheral Intravenous Catheterization(Length of Emergency Department stay (Time Frame: up to 12 hours))