A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine
Status:
Completed
Trial end date:
2020-12-03
Target enrollment:
Participant gender:
Summary
Headaches in children are very common and are a source of significant distress for the
patient and their family. Migraines are the most common headache disorder in children and are
associated with episodic pain and other symptoms such as nausea and sensitivity to light and
sound that can impair a child's ability to participate in daily activities and lead to missed
school or parental missed work. When home treatment fails to relieve symptoms, children often
seek care in the emergency department (ED) where a limited number of treatment options exist;
while largely effective, these rescue treatments currently all require needle insertion of an
intravenous line, take time to administer, result in prolonged ED stays, and have potential
unpleasant side effects. In adult patients, a number of studies suggest that lidocaine, a
local anesthetic administered intranasally, may provide relief of migraine and migraine-like
headache pain in minutes. This approach has the benefit of working quickly, not requiring a
needle, and having fewer side effects as the medication acts locally on nerves in the nose.
Intranasal lidocaine has not yet been studied in children for this purpose. This study will
compare the use of intranasal lidocaine to placebo. The goal of this pilot study is to
provide information to inform the sample size calculation for the definitive randomized
controlled trial that will aim to measure the efficacy of intranasal lidocaine as an
analgesic option for children age 7 years and older who present to the Pediatric ED with a
chief complaint of migraine or post traumatic headache with migraine-like features. Secondary
objectives will be to report on the frequency and severity of rebound headache between the
two treatment groups, adverse events of the study drug, as well as the impact on healthcare
utilization measures.The investigators hypothesize that children receiving intranasal
lidocaine will have faster and more effective pain recovery compared to children receiving
placebo and will be less likely to require the standard therapy for migraine headache. Given
very few side effects reported in adult studies and the relatively benign nature of those
reported, the investigators do not expect any major safety concerns in the study. It is also
hypothesized that intranasal lidocaine will lead to shorter ED visits, thus reducing use of
staff and hospital resources and saving money for the healthcare system as a whole.