Optic

ID

Name

15.0827

Description

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).

Trial arms

Trial start

2016-02-01

Estimated PCD

2024-11-01

Trial end

2024-11-01

Status

Recruiting

Treatment

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.

Arms:

Auricular Acupuncture

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

Arms:

Medication and Fluid

Other names:

Toradol

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

Arms:

Medication and Fluid

Other names:

Reglan

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

Arms:

Medication and Fluid

Other names:

Benadryl

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

Arms:

Medication and Fluid

Other names:

Normal Saline

Size

80

Primary endpoint

Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)

Baseline and 15 minutes after completion of intervention

Eligibility criteria

Inclusion Criteria: * Confirmation of the diagnosis of migraine headache Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-10-10

Organization

University of Louisville

Product

Indication

Product

Product

Product

Normal saline fluid bolus

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