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Trial record 51 of 3374 for:    Louisville

Auricular Acupuncture vs SOC in Migraine HA (MigAcu)

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ClinicalTrials.gov Identifier: NCT02681211
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Danielle Graff, University of Louisville

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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:

  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

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
Other Name: 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:

  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
Other Name: 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:

  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
Other Name: 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:

  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
Other Name: Normal Saline




Primary Outcome Measures :
  1. 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 ]
    Pre-and post-intervention pain scores (0 to 10) by a numerical self-reported visual analog pain score (VAS)


Secondary Outcome Measures :
  1. Duration of pain relief using the VAS pain scale [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681211


Contacts
Contact: Danielle Graff, MD 502-629-7212 dmgraf02@louisville.edu
Contact: Mark J McDonald, MD 602-852-3720 mjmcdo01@louisville.edu

Locations
United States, Kentucky
Norton Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Danielle M Graff, MD, MSc         
Principal Investigator: Danielle M Graff, MD, MSc         
Sub-Investigator: Mark McDonald, MD         
Sub-Investigator: Ron Paul, MD         
Sub-Investigator: Amy Hanson, MD         
Sub-Investigator: Keith Cross, MD         
Sub-Investigator: Brit Anderson, MD         
Norton Children's Medical Center Recruiting
Louisville, Kentucky, United States, 40241
Contact: Danielle Graff, MD, MSc         
Principal Investigator: Danielle Graff, MD, MSc         
Sub-Investigator: Mark McDonald, MD         
Sub-Investigator: Keith Cross, MD         
Sub-Investigator: Amy Hanson, MD         
Sub-Investigator: Ron Paul, MD         
Sub-Investigator: Brit Anderson, MD         
Sponsors and Collaborators
University of Louisville
Investigators
Study Director: Janice Sullivan, MD University of Louisville

Responsible Party: Danielle Graff, Clinical Instructor, University of Louisville
ClinicalTrials.gov Identifier: NCT02681211     History of Changes
Other Study ID Numbers: 15.0827
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Danielle Graff, University of Louisville:
migraine headache
acupuncture

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Diphenhydramine
Metoclopramide
Promethazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Antiemetics