Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- One hour change in pain
研究概览
简要总结
The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are:
- Does a large amount of fluids (bolus) improve pain
- Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours.
Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.
详细描述
Patients will be randomized to one of two treatment groups. The intervention group will receive a 20 mL/kg bolus of normal saline (with a maximum of 1L), given over one hour.
The control group will receive normal saline at half maintenance (with a maximum of 50mL/hr) over one hour.
Both groups will receive:
- ketoralac (Toradol), 0.5mg/kg, with a maximum of 30mg
- diphenhydramine(Benadryl), 0.5mg/kg, with a maximum of 25mg
- prochlorperazine(Compazine), 0.15mg/kg, with a maximum of 10mg
Pain score, heart rate, and blood pressure will be monitored every 30 minutes from the start of the medications/fluids being started, for a period of two hours. Pain will be recorded using a 100mm visual analog scale.
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
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 1 prior headache
- •Minimum pain score of 10mm
- •Headache lasting 2-72 hours
- •At least two of the following four: 1 Bifrontal/bitemporal or unilateral location, 2 Pulsating quality, 3 Moderate or severe pain intensity, 4 Aggravation by or causing avoidance of routine physical activity
- •At least one of the following: 1 Nausea and/or vomiting, 2Photophobia and phonophobia, 3 Not better accounted for by another ICHD-3 diagnosis
排除标准
- •Shunted hydrocephalus
- •Temperature equal to or greater than 38.5C
- •Clinical suspicion of meningitis
- •Known or suspected intracranial lesion
- •Clinical evidence of significant dehydration (or signs of shock, or attending discretion)
- •Head trauma in previous 7 days
- •Pregnancy or breastfeeding
- •Initial pain score less than 10mm
- •Allergy to study medications
- •Patients previously participating in the study
研究组 & 干预措施
Bolus
Will receive a normal saline bolus
干预措施: Ketorolac (Drug)
Bolus
Will receive a normal saline bolus
干预措施: Diphenhydramine (Drug)
Bolus
Will receive a normal saline bolus
干预措施: Prochlorperazine (Drug)
Bolus
Will receive a normal saline bolus
干预措施: bolus (Other)
Control
Will receive 1/2 maintenance normal saline
干预措施: 1/2 maintenance fluids (Other)
Control
Will receive 1/2 maintenance normal saline
干预措施: Ketorolac (Drug)
Control
Will receive 1/2 maintenance normal saline
干预措施: Diphenhydramine (Drug)
Control
Will receive 1/2 maintenance normal saline
干预措施: Prochlorperazine (Drug)
结局指标
主要结局
One hour change in pain
时间窗: one hour
Mean change from baseline pain score, taken at one hour from beginning data collection. A 100 mm visual analog scale is used, with a higher score indicating higher pain. A greater change in pain score means more improved pain.
次要结局
- return visits(Through study completion, up to 48 hours after completion of study protocol.)
- Resolution of pain(Through study completion, up to 24 hours after enrollment)
- length of emergency stay(Through study completion, up to 24 hours after patient enrollment.)
- Admission rate(during emergency department visit, up to 24 hours after patient enrollment)
- Two hour change in pain(two hours)
- 50% reduction of pain(Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department)
研究者
Jonathan Elliott, MD
Principal Investigator
Dayton Children's Hospital