Auricular Acupuncture vs SOC in Migraine HA

Conditions:Migraine Headaches, Migraine Headaches
Therapuetic Areas:Neurology
Age Range:8 - 18
Start Date:February 2016
End Date:June 2019
Contact:Danielle Graff, MD

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

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).

Potential subjects will be identified using the diagnosis of migraine headache classified by
the modified ICHD-II (International Classification for Headache Disorders) criteria proposed
by Hershey et. al. This diagnosis will be confirmed by the investigators prior to enrollment
of the subject and will be documented in the study documents. Subjects will be recruited
during the scheduled work or research hours of the investigators in the ED.

Eligible patients will be informed of the study including a discussion of the two possible
interventions. After informed consent and assent are obtained, patients will be randomly
assigned 1 of the 2 arms of the study. The target is 40 subjects in each arm. Subjects will
be assigned to a study group using a computer generated randomization schema. This
randomization will only be known to one unblinded collaborator that will not be enrolling
subjects or be involved in the data analysis.

If assigned to receive intravenous migraine medications the subject will be treated with the
standard of care medications which include ketorolac (0.5mg/kg, max 30mg), metoclopramide
(0.1 mg/kg, max 10mg), diphenhydramine (1mg/kg, max 50mg) plus a normal saline fluid bolus
(20mL/kg, max 1000mL).

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.
If the subject does not improve with acupuncture, they will be assessed by the ED physician
and at the MD discretion further emergency department treatment will be administered which
may include intravenous migraine medications as this is the current standard of care in the
Norton Children's Hospital/Norton Children's Medical Center (KCH/KCMC) ED.

All subjects will be contacted 2 to 6 days after discharge to determine their clinical
status. If the darts are still in place at the follow-up call, the subjects will be contacted
at 2 weeks and weekly thereafter until all darts have fallen out.

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
We found this trial at
Louisville, Kentucky 40202
Principal Investigator: Danielle M Graff, MD, MSc
Louisville, KY
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Louisville, Kentucky 40241
Principal Investigator: Danielle Graff, MD, MSc
Louisville, KY
Click here to add this to my saved trials