NCT02681211

Auricular Acupuncture vs SOC in Migraine HA

A Randomized Trial Comparing Auricular Acupuncture and Intravenous Migraine Medications in the Treatment of Status Migrainosus in the Pediatric Emergency Department

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
OTHER	Auricular Acupuncture	ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.
DRUG	Ketorolac 0.5mg/kg, max 30mg	If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include: 1. Ketorolac 0.5mg/kg, max 30mg 2. Metoclopramide 0.1 mg/kg, max 10mg 3. Diphenhydramine 1mg/kg, max 50mg 4. Normal saline fluid bolus 20mL/kg, max 1000mL
DRUG	Metoclopramide 0.1 mg/kg, max 10mg	If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include: 1. Ketorolac 0.5mg/kg, max 30mg 2. Metoclopramide 0.1 mg/kg, max 10mg 3. Diphenhydramine 1mg/kg, max 50mg 4. Normal saline fluid bolus 20mL/kg, max 1000mL
DRUG	Diphenhydramine 1mg/kg, max 50mg	If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include: 1. Ketorolac 0.5mg/kg, max 30mg 2. Metoclopramide 0.1 mg/kg, max 10mg 3. Diphenhydramine 1mg/kg, max 50mg 4. Normal saline fluid bolus 20mL/kg, max 1000mL
DRUG	Normal saline fluid bolus 20mL/kg, max 1000mL	If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include: 1. Ketorolac 0.5mg/kg, max 30mg 2. Metoclopramide 0.1 mg/kg, max 10mg 3. Diphenhydramine 1mg/kg, max 50mg 4. Normal saline fluid bolus 20mL/kg, max 1000mL

Timeline

• Start date: 2016-02-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2016-02-12
• Last updated: 2023-10-10

Locations

2 sites across 1 country: United States