MigAcu: Auricular Acupuncture vs SOC in Migraine HA

Sponsor

University of Louisville (Other)

Overall Status

Recruiting

CT.gov ID

NCT02681211

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Migraine Headache	Other: Auricular Acupuncture 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	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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: 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	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: 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 Other Names: Toradol 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: 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 Other Names: Reglan 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: 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 Other Names: Benadryl 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: 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 Other Names: Normal Saline

Arm

Intervention/Treatment

Experimental: Auricular Acupuncture

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.

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: 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

Drug: Ketorolac 0.5mg/kg, max 30mg

Other Names:

Toradol

Drug: Metoclopramide 0.1 mg/kg, max 10mg

Other Names:

Reglan

Drug: Diphenhydramine 1mg/kg, max 50mg

Other Names:

Benadryl

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

Other Names:

Normal Saline

Outcome Measures

Primary Outcome Measures

Change in baseline pain score by a numerical self-reported visual analog pain score (VAS) [Baseline and 15 minutes after completion of intervention]
Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)

Secondary Outcome Measures

Duration of pain relief using the VAS pain scale [2 to 6 days]
Data to be collected on this phone follow-up include return of migraine/headache using the VAS pain scale; return to ED or PMD for migraine/headache symptoms; and medications taken for headache since discharge from the ED.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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