Auricular Acupuncture for Migraines (MigAcu Trial)

Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Recruiting

Sponsor: University of Louisville

No Placebo Group

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This trial compares ear acupuncture and standard IV medications for treating migraines in children in the emergency room. Ear acupuncture uses needles in the ear to change nerve signals and reduce pain, while standard treatments use drugs to relieve symptoms.

Eligibility Criteria

This trial is for pediatric patients with confirmed migraine headaches who haven't taken any ED migraine medications like ibuprofen before the study. It's not for those allergic to the meds used in this trial, showing specific neurological symptoms, or with brain conditions like a mass or bleed causing their migraines.

Exclusion Criteria

I have taken migraine medication, including ibuprofen, before this study.

My migraines may be caused by a brain condition like a tumor or bleeding.

Treatment Details

The study compares auricular acupuncture against standard treatments (including Ketorolac, Metoclopramide, Diphenhydramine, and saline fluid) for migraines in children at the emergency department. Patients are randomly chosen to receive either acupuncture or standard care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Auricular AcupunctureExperimental Treatment1 Intervention

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.

Group II: Medication and FluidActive Control4 Interventions

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

Auricular Acupuncture is already approved in China, European Union, United States for the following indications:

🇨🇳 Approved in China as Auricular Acupuncture for: