A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine
Condition: Migraine in Children; Posttraumatic Headache
MeSH terms: Migraine Disorders; Post-Traumatic Headache; Headache
Study type: Interventional
Phase: Phase 1

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.
    


Intervention name(s): Lidocaine 2% Injectable Solution; Normal Saline Flush, 0.9% Injectable Solution
Intervention type(s): Drug; Drug
Intervention description(s): The Barre method of intranasal administration will be used to instil 1mL of lidocaine 2% in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.; The Barre method of intranasal administration will be used to instil 1mL of saline 0.9% in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.
Intervention MeSH terms: Lidocaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment