Auricular Acupuncture vs SOC in Migraine HA

NCT02681211 | Unknown

• 1 other identifier: 15.0827
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

migraine headache; acupuncture

Outcome Measures

Primary Outcomes (1)

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

  Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)

  Baseline and 15 minutes after completion of intervention

Secondary Outcomes (1)

• Duration of pain relief using the VAS pain scale

  2 to 6 days

Study Arms (2)

Auricular Acupuncture

EXPERIMENTAL

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.

Other: Auricular Acupuncture

Medication and Fluid

ACTIVE COMPARATOR

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: Ketorolac 0.5mg/kg, max 30mg; Drug: Metoclopramide 0.1 mg/kg, max 10mg; Drug: Diphenhydramine 1mg/kg, max 50mg; Drug: Normal saline fluid bolus 20mL/kg, max 1000mL

Interventions

Auricular Acupuncture OTHER

ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.

Auricular Acupuncture

Ketorolac 0.5mg/kg, max 30mg DRUG

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

Also known as: Toradol

Medication and Fluid

Metoclopramide 0.1 mg/kg, max 10mg DRUG

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

Also known as: Reglan

Medication and Fluid

Diphenhydramine 1mg/kg, max 50mg DRUG

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

Also known as: Benadryl

Medication and Fluid

Normal saline fluid bolus 20mL/kg, max 1000mL DRUG

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

Also known as: Normal Saline

Medication and Fluid

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Confirmation of the diagnosis of migraine headache

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (2)

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Children's Medical Center

Louisville, Kentucky, 40241, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture, Ear; Ketorolac; MAX protein, human; Ketorolac Tromethamine; Metoclopramide; Diphenhydramine; Saline Solution

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Ethylamines; Amines; Benzhydryl Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Janice Sullivan, MD

  University of Louisville

  STUDY DIRECTOR

Central Study Contacts

Danielle Graff, MD

CONTACT

502-629-7212; dmgraf02@louisville.edu

Mark J McDonald, MD

CONTACT

602-852-3720; mjmcdo01@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 12, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)