Oral v. Parenteral Medications for the Emergency Management of Acute Migraine: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 55
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this pilot randomized control trial is to assess the feasibility of our patient recruitment and data collection strategy ahead of a full scale RCT investigating the efficacy of oral v. parenteral medications in the management of acute migraine headaches in the emergency department. Patients will be randomly assigned to receive either (A) standard medical therapy for the treatment of acute migraine headache (metoclopramide and ketorolac IV) and oral placebo or (B) oral metoclopramide and ibuprofen with normal saline IV. Primary outcome measures are recruitment rate and improvement in pain score at 60 minutes from medication administration.
详细描述
Objectives
The planned study is a pilot study designed to assess the feasibility of our recruitment and data collection strategy. The primary feasibility outcome will be recruitment rate, which is defined as the proportion of eligible patients approached who are successfully recruited over the proposed 6-month pilot study period. Our secondary feasibility outcomes are (a) proportion of eligible patients approached and (b) rate of attrition during the study period.
Our preliminary primary outcome will be improvement in pain from baseline to 60 minutes after medication administration using the visual analogue scale (Bijur et al. 2008). Preliminary secondary outcomes will include headache relief and freedom from headache at 2 h, the need for rescue medication, ED length of stay and return to ED within 24h of discharge. The frequency of adverse effects, including gastrointestinal upset, patient-reported restlessness or dystonic reaction and fatigue, will be assessed.
Design
In this parallel, noninferiority, double-blind randomised control pilot study, eligible patients presenting to the emergency department with a chief complaint of headache will be randomly assigned with an allocation ratio of 1:1 to receive one of 2 treatments: intravenous ketorolac (10 mg) and metoclopramide (10 mg) v. oral ibuprofen (400 mg) and metoclopramide (10 mg). Dosing was selected to reflect the lowest effective doses recommended for emergency department management of migraine headaches (Friedman et al. 2011, Motov et al. 2017). The study will last 6 months at which time it will stop.
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)
盲法说明
Treatment will be randomly assigned using a random number generator by an independent research assistant who is not involved in data collection. Contents of treatment will be known only to the research pharmacist and this information will be stored remotely from the ED; patients, administering nurses and treating physicians will be blind to the treatment group, as well the research assistants collecting outcome data.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presentation to emergency department with headache
排除标准
- •Vomiting or unable to tolerate PO at tie of med admin
- •Focal neurologic symptoms
- •Head trauma within 14d
- •Pregnancy
- •Concurrent use of blood thinners
- •Hypersensitivity reaction to any of the study medications
- •>14 HA days per month
研究组 & 干预措施
Oral medications
10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml NS administered over 15 minutes.
干预措施: Oral metoclopramide and ibuprofen (Drug)
IV medications
2 x placebo tablets, 10 mg metoclopramide in 50 cc NS and 10 mg ketorolac in 50 ml NS administered over 15 min.
干预措施: Intravenous metoclopramide and ketorolac (Drug)
结局指标
主要结局
Recruitment rate
时间窗: 6 months
Proportion of eligible patients presenting to ED who are successfully recruited
Pain relief
时间窗: 60 minutes
Change in visual analogue scale (0-10 where 0 is no pain and 10 is maximal pain) from baseline to 60 minutes after medication administration
次要结局
- Proportion of eligible patients approached(6 months)
- Rate of attrition during the study period(24 hours)
- Pain relief at 2 hours(120 minutes)
- Need for rescue medication(24 h)
- Freedom from headache(60 minutes)
- Emergency department length of stay(24 hours)
- Adverse reactions(24 hours)
- Return to emergency department(24 hours)