Clinical trial NCT02681211: Auricular Acupuncture vs SOC in Migraine HA
Official title: A Randomized Trial Comparing Auricular Acupuncture and Intravenous Migraine Medications in the Treatment of Status Migrainosus in the Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine Headache
Keywords: migraine headache
acupuncture
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Change in baseline pain score by a numerical self-reported visual analog pain score (VAS)
timeFrame: Baseline and 15 minutes after completion of intervention
Secondary outcomes:
measure: Duration of pain relief using the VAS pain scale
timeFrame: 2 to 6 days
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Children's Medical Center
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Janice Sullivan, MD
role: STUDY_DIRECTOR
References: