Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:34 PM
Ignite Modification Date:
2025-12-24 @ 1:34 PM
NCT ID:
NCT03806595
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 7-16 years
2. 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:
3. 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
4. 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
5. Normal vital signs for age
6. Normal neurological exam (no focal deficits or abnormalities)
Exclusion Criteria:
1. Families not providing informed consent or assent, where appropriate
2. History of acute trauma or seizure in the preceding 24 hours
3. Clinical suspicion of or known intracranial pathology or underlying central nervous system disease
4. Headache associated with fever or meningismus
5. Known allergy/sensitivity to lidocaine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
16 Years
Study:
NCT03806595
Study Brief:
Protocol Section:
NCT03806595