A Randomized Trial Comparing Auricular Acupuncture and Intravenous Migraine Medications in the Treatment of Status Migrainosus in the Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
研究概览
简要总结
Patients with migraine headache will be offered the opportunity to participate in this randomized study evaluating auricular acupuncture versus standard treatment for migraine headaches for patients in the pediatric emergency department (ED).
详细描述
Potential subjects will be identified using the diagnosis of migraine headache classified by the modified ICHD-II (International Classification for Headache Disorders) criteria proposed by Hershey et. al. This diagnosis will be confirmed by the investigators prior to enrollment of the subject and will be documented in the study documents. Subjects will be recruited during the scheduled work or research hours of the investigators in the ED.
Eligible patients will be informed of the study including a discussion of the two possible interventions. After informed consent and assent are obtained, patients will be randomly assigned 1 of the 2 arms of the study. The target is 40 subjects in each arm. Subjects will be assigned to a study group using a computer generated randomization schema. This randomization will only be known to one unblinded collaborator that will not be enrolling subjects or be involved in the data analysis.
If assigned to receive intravenous migraine medications the subject will be treated with the standard of care medications which include ketorolac (0.5mg/kg, max 30mg), metoclopramide (0.1 mg/kg, max 10mg), diphenhydramine (1mg/kg, max 50mg) plus a normal saline fluid bolus (20mL/kg, max 1000mL).
If assigned to the auricular acupuncture arm, efficacious ear points will be located by a needle contact test and/or an electrical point finder which emits an acoustic alarm when a change in electrical resistance is detected signifying a potential active auricular acupoint. If the subject does not improve with acupuncture, they will be assessed by the ED physician and at the MD discretion further emergency department treatment will be administered which may include intravenous migraine medications as this is the current standard of care in the Norton Children's Hospital/Norton Children's Medical Center (KCH/KCMC) ED.
All subjects will be contacted 2 to 6 days after discharge to determine their clinical status. If the darts are still in place at the follow-up call, the subjects will be contacted at 2 weeks and weekly thereafter until all darts have fallen out.
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
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmation of the diagnosis of migraine headache
排除标准
- •Patients who received ED migraine medications (including ibuprofen or other NSAIDS) prior to study evaluation.
- •Allergy to any of the medications used in our migraine regimen protocol.
- •Patients exhibiting focal clinical neurological exam findings that the investigator deems makes the patient not a good candidate for this study.
- •Patients with underlying abnormal brain pathology (e.g. mass or bleed) as the potential cause of the migraine
研究组 & 干预措施
Auricular Acupuncture
If assigned to the auricular acupuncture arm, efficacious ear points will be located by a needle contact test and/or an electrical point finder which emits an acoustic alarm when a change in electrical resistance is detected signifying a potential active auricular acupoint.
干预措施: Auricular Acupuncture (Other)
Medication and Fluid
If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
- Ketorolac 0.5mg/kg, max 30mg
- Metoclopramide 0.1 mg/kg, max 10mg
- Diphenhydramine 1mg/kg, max 50mg
- Normal saline fluid bolus 20mL/kg, max 1000mL
干预措施: Ketorolac 0.5mg/kg, max 30mg (Drug)
Medication and Fluid
If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
- Ketorolac 0.5mg/kg, max 30mg
- Metoclopramide 0.1 mg/kg, max 10mg
- Diphenhydramine 1mg/kg, max 50mg
- Normal saline fluid bolus 20mL/kg, max 1000mL
干预措施: Metoclopramide 0.1 mg/kg, max 10mg (Drug)
Medication and Fluid
If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
- Ketorolac 0.5mg/kg, max 30mg
- Metoclopramide 0.1 mg/kg, max 10mg
- Diphenhydramine 1mg/kg, max 50mg
- Normal saline fluid bolus 20mL/kg, max 1000mL
干预措施: Diphenhydramine 1mg/kg, max 50mg (Drug)
Medication and Fluid
If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
- Ketorolac 0.5mg/kg, max 30mg
- Metoclopramide 0.1 mg/kg, max 10mg
- Diphenhydramine 1mg/kg, max 50mg
- Normal saline fluid bolus 20mL/kg, max 1000mL
干预措施: Normal saline fluid bolus 20mL/kg, max 1000mL (Drug)
结局指标
主要结局
Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
时间窗: Baseline and 15 minutes after completion of intervention
Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)
次要结局
- Duration of pain relief using the VAS pain scale(2 to 6 days)
研究者
Danielle Graff
Associate Professor
University of Louisville