NCT03806595

A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine

A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine and Migraine-like Headache: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 7 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Migraine in Children
• Posttraumatic Headache

Interventions

Type	Name	Description
DRUG	Lidocaine 2% Injectable Solution	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.
DRUG	Normal Saline Flush, 0.9% Injectable Solution	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.

Timeline

• Start date: 2019-07-03
• Primary completion: 2020-12-03
• Completion: 2020-12-03
• First posted: 2019-01-16
• Last updated: 2021-04-28

Locations

1 site across 1 country: Canada