Intranasal Lidocaine to Treat Pediatric Migraine in the Emergency Department



Status:Recruiting
Conditions:Migraine Headaches, Hospital
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:10 - 20
Updated:3/3/2019
Start Date:October 15, 2018
End Date:December 2019
Contact:Wende Gelb, MD
Email:gelbw@nychhc.org
Phone:718-918-5312

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The purpose of the study is to determine the effect of intranasal lidocaine on pain score in
pediatric patients with migraine. Patients with significant pain after oral analgesics and
plan for intravenous (IV) abortive therapy will be asked to participate. Half of patients
will be given intranasal lidocaine and the other half will be given placebo. Pain scores and
associated migraine symptoms (i.e. nausea, vomiting, photophobia, phonophobia, avoidance of
activities, and aura) will be monitored and compared between the groups.

This will be a double-blinded, randomized-controlled trial using intranasal lidocaine to
provide fast-acting pain relief in pediatric patients presenting with migraine to an urban
pediatric emergency department (ED). Typically, abortive therapy for migraine in many
emergency departments begins with oral analgesics such as ibuprofen and acetaminophen.
However, many patients with inadequate pain relief after oral analgesics will require
intravenous (IV) medications to abort their migraine symptoms. These medications can take up
to thirty minutes or more for the onset of action to begin, potentially leaving patients in
significant pain during that time. Also, obtaining IV access in children can be
time-consuming and technically difficult, further delaying time to pain relief. Subjects will
be given either intranasal lidocaine or placebo while awaiting IV placement and IV
metoclopramide administration. Pain scales and associated migraine symptoms will be compared
between the two arms before study medication administration and again at 5, 10, and 20
minutes.

Inclusion Criteria:

- Patients who will be receiving IV metoclopramide because their migraine is refractory
to oral analgesics, as determined by the treating physician.

- Moderate to severe headache with NRS score greater than or equal to 6

- Headache lasting between 2-72 hours

- Two of the following:

1. non-occipital location of headache (frontal, frontotemporal, or unilateral)

2. pulsating or throbbing quality

3. aggravated by or causing avoidance of routine physical activity

4. nausea, vomiting, or both

5. photophobia and/or phonophobia (may be inferred from behavior)

Exclusion Criteria:

- unstable vital signs

- pregnancy

- lactating

- altered mental status

- developmental delay

- intractable vomiting

- first-time headache

- history of cardiac arrythmia

- previous adverse reaction or allergy to lidocaine

- non-English speaking
We found this trial at
1
site
1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Principal Investigator: Katherine Chou, MD
Phone: 718-918-5312
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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from
Bronx, NY
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