Auricular Acupuncture vs SOC in Migraine HA

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).

Conditions

• Migraine Headache

Interventions

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

Sponsors & Collaborators

• University of Louisville

  lead OTHER

Principal Investigators

• Janice Sullivan, MD · University of Louisville

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2024-11-30

Completion

2024-11-30

Countries

• United States

Study Locations