Recruiting

Auricular Acupuncture vs. SOC

Sponsor:

University of Louisville

Code:

NCT02681211

Conditions

Migraine Headache

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Auricular Acupuncture

Ketorolac 0.5mg/kg, max 30mg

Metoclopramide 0.1 mg/kg, max 10mg

Diphenhydramine 1mg/kg, max 50mg

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

Study Details

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

Study ID

NCT02681211

Start date

Feb, 2016

Status verified date

Oct, 2023

Completion date

Nov, 2024

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auricular Acupuncture

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.

active comparator: Medication and Fluid

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

Interventions

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.

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

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

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

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

Primary outcome measure

  • Change in baseline pain score by a numerical self-reported visual analog pain score (VAS) [ Time Frame: Baseline and 15 minutes after completion of intervention ]

Central Contacts and Locations

Central contacts

Danielle Graff, MD

502-629-7212dmgraf02@louisville.edu

Mark J McDonald, MD

602-852-3720mjmcdo01@louisville.edu

Locations

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Danielle M Graff, MD, MSc

Norton Children's Medical Center

Recruiting

Louisville, Kentucky, United States, 40241

Principal Investigator:

Danielle Graff, MD, MSc

More Information

Sponsor

University of Louisville

Last update posted

Oct 10, 2023

Last verified

Oct, 2023

Keywords

  • migraine headache
  • acupuncture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2023-10-10.