Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in median pian VAS score
研究概览
简要总结
Headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. Of these headaches, approximately 90% are migraine, tension headache, or combined presentations. The most commonly used migraine therapy in the ED is intravenous prochlorperazine, but its administration requires close nursing observation, a bed, and the insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form of delivery that enables rapid achievement of therapeutic blood levels and may lead to symptom resolution. In a randomized, controlled, prospective study,the investigators plan to assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency department treatment of migraine headaches.
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
- •Patients between 18-65 years of age evaluated in the emergency department at Harbor-UCLA with migraine headache as defined by the Headache Classification Committee of the International Headache Society. (Patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia).
- •Only subjects able to consent to treatment will be included.
排除标准
- •Patients with the following conditions:
- •pregnancy
- •breastfeeding
- •fever greater or equal to 100.4 degrees
- •diastolic blood pressure of 105 or higher
- •altered mental status
- •meningeal signs
- •suspicion for intracranial process requiring further investigation
- •known allergy to prochlorperazine
- •the use of ergotamines, antiemetics, antipsychotics or sedatives in the previous 24 hours of study entry.
研究组 & 干预措施
Buccal Prochlorperazine
Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline
干预措施: Prochlorperazine (Drug)
Intravenous Prochlorperazine
Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.
干预措施: Prochlorperazine (Drug)
结局指标
主要结局
Change in median pian VAS score
时间窗: From Time 0 (baseline) to Time 60 minutes after administration of medication
Primary end point will be a detectable difference in the median pain VAS score recorded from Time 0 (baseline) to Time 60 minutes (conclusion of the study) for each of the two groups.
次要结局
- Change in median sedation VAS scores(From Time 0 (baseline) to Time 60 minutes after administration of medication)
- Rescue Medication(At the conclusion of the study (60 minutes))
- Change in median nausea VAS scores(From Time 0 (baseline) to Time 60 minutes after administration of medication)
- Follow-up for persistence or recurrence of headache(24 -48 hours)
研究者
David Tanen
Professor of Medicine
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center