Status:
COMPLETED
A Pilot Study of Intranasal Lidocaine in Acute Management of Pediatric Migraine
Lead Sponsor:
University of British Columbia
Conditions:
Migraine in Children
Posttraumatic Headache
Eligibility:
All Genders
7-16 years
Phase:
PHASE1
Brief 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 epi...
Eligibility Criteria
Inclusion
- Children aged 7-16 years
- Migraine headache fulfilling Irma's criteria:
- Headache lasting 1-72 hours with at least 4 out of 6 of the following features:
- Moderate to severe episode of impaired daily activities
- Focal localization of headache
- Pulsatile description
- Nausea or vomiting or abdominal pain
- Photophobia, phonophobia, or avoidance of light and noise, or
- Symptoms increasing with activity or resolving by rest.
- OR:
- Post-traumatic headache as per ICHD-3 (beta edition) definition with migraine-like features (see above):
- A) Any headache fulfilling criteria C and D
- B) Traumatic injury to the head has occurred
- C) Headache is reported to have developed within 7 days after one of the following:
- i. The injury to the head, ii. Regaining of consciousness following the injury to the head, iii. Discontinuation of medication(s) that impair ability to sense or report headache following the injury to the head
- D) Headache persists for \> 3 months after the injury to the head
- E) Not better accounted for by another ICHD-3 diagnosis
- Verbal report of a pain score of 4 or greater on a 10 point numeric pain score (range 0-10 with increasing severity, i.e. 0 = no pain and 10 = most severe pain) after receiving first line therapy (non-narcotic analgesia) in either the out-patient or PED setting
- Normal vital signs for age
- Normal neurological exam (no focal deficits or abnormalities)
Exclusion
- Families not providing informed consent or assent, where appropriate
- History of acute trauma or seizure in the preceding 24 hours
- Clinical suspicion of or known intracranial pathology or underlying central nervous system disease
- Headache associated with fever or meningismus
- Known allergy/sensitivity to lidocaine
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03806595
Start Date
July 3 2019
End Date
December 3 2020
Last Update
April 28 2021
Active Locations (1)
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1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1