Low- Dose Propofol Infusion as an Abortive Treatment for Migraine Headaches in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in Headache Pain Score
研究概览
简要总结
Propofol has been used in adult populations to treat migraines as an abortive agent. Investigators plan to investigate its efficacy as an abortive agent in the pediatric population when administered as a safe low-dose infusion. Goals of the study are to:
- Evaluate efficacy of low-dose propofol infusion as an abortive agent in pediatric migraine headaches
- Evaluate effective and safe dosing limits in pediatric populations
- Evaluate duration of effect reached from a low-dose propofol infusion as an abortive agent
Endpoints for the study will be:
- Number of enrolled patients
- Safety endpoints reached, including: cardiopulmonary depression, excessive somnolence Risks of the study are minimal due to the use of sub-anesthetic dosing of propofol under the guidance and supervision of a board certified pediatric anesthesiologist with the appropriate monitoring equipment and readily available emergency equipment. Investigators hope to demonstrate more rapid improvement and decreased side-effect as compared to standard care.
详细描述
The aim of this prospective study is to evaluate the efficacy and safety of propofol administration in a hospital setting, as an abortive medication for children aged 7-18 with migraines.
Primary outcome:
Based on the adult and the limited pediatric data available we hypothesize that propofol infusion in sub anesthetic dose, will result in either complete resolution or improve the headache pain scores by 50% from the baseline pain scores. Patients will be assessed with a 0-10 Numeric Pain Rating Scale.
Secondary outcomes:
- Time to beginning of effect (from the beginning of the propofol infusion till first improvement in pain score noted)
- Duration of effect (from the end of propofol administration till discharge criteria are meet or if treatment is ineffective, till start of new therapy)
- Total propofol dose based on weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of migraine headache per ICHD - 3 (International Classification of Headache Disorders)
- •The subjects will have a history of migraine headaches with a presentation consistent with presentations of their headaches in the past with no indication for further investigation for secondary causes of his/her headache
- •Documented pain score greater than or equal to 6 on a 0-10 Numeric Pain Rating Scale
- •Current migraine has a greater than 24 hours duration with a current pain score of 6 or greater on a 0-10 Numeric Pain Rating Scale
- •Subjects will be scheduled for DHE infusion therapy for treatment of migraines per standard medical care
- •Patients age 7-18 years old
- •Gender: both male and female
- •Appropriate fasting interval as per ASA guidelines
排除标准
- •No long acting triptan therapy within 24 hours
- •No shorter acting triptan therapy within 6 hours
- •No ergot alkaloid derivatives within the last 24 hours
- •No opioid within 2 hours
- •No NSAID or acetaminophen within 1 hour of infusion
- •Use of sedative medications within 6 hours of infusion, including opioids, benzodiazepines, barbiturates
- •Headache not consistent with subject's headache history needing further work-up
- •Headache duration less than 24 hours
- •Subjects in which an intravenous line could not be secured
- •Subjects with history of significant reflux or hiatal hernia
- •Subjects with history of significant cardio pulmonary disorders
- •Patient not fasting as per ASA guidelines
研究组 & 干预措施
Propofol infusion
All subjects will be treated with an intravenous propofol infusion at the following escalating rate schedule:
20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes
干预措施: Propofol (Drug)
结局指标
主要结局
Improvement in Headache Pain Score
时间窗: Duration of propofol infusion (between 5 and 60 minutes)
Change in pain score on 0-10 Numeric Pain Rating Scale with 0 being no pain and 10 being severe pain. Subjects assessed at 10 minute intervals for the duration of the infusion with reporting of change from baseline to 60 minutes
次要结局
- NPRS Pain Scores at 24 and 48 Hours Post Infusion(Assessments of NPRS Pain scores on a scale of 0-10 with 0 being no pain and 10 being severe pain at 24 and 48 hours after discharge from infusion)
- Total Propofol Dose(60 minutes)
研究者
Deryk Walsh
Associate Professor
University of Texas Southwestern Medical Center