Occipital Blocks for Acute Migraine

There are two substantial hurdles that must be overcome in designing a trial to test the
efficacy of PNBs: high placebo response rate and possible unblinding. In order to test the
efficacy of this commonly used treatment for children and adolescents with difficult-to-treat
headache, we need utilize a trial design which will address the high placebo response rate
and the potential lack of blinding.

About 58 children, recruited over a 3.5 year period at Children's Hospital of Philadelphia,
will take part in this study. Participation will last about one month and involve one
in-person study visit, and then completion of headache-related surveys, at home, for 28 days.
Lidocaine cream lead-in will be used open-label for all subjects followed by double-blind
randomized injections of active treatment (lidocaine) versus comparator (saline) in subjects
who continue to have significant headache.

To accomplish our secondary objectives, we will examine how expectation is affected by
perceived treatment, and how expectations, measured in patients, parents, and providers,
influence outcomes in pediatric and adolescent acute migraine.

Inclusion Criteria:

- Children / Adolescents:

- Males or females, ages 7 - 17, of any gender, race, or ethnicity

- Diagnosis of episodic or chronic migraine with acute headache flare lasting 24
hours to 4 weeks unresponsive to acute oral and/or nasal medications. Patients
who report that acute medications were not used during this headache flare
because those medications have been ineffective for several prior headache flares
will be included

- Informed parental consent and subject assent

- Girls, who have reached menarche, must have a negative urine or serum pregnancy
test

- Weight > 25kg

- Parents:

- Parents or guardians of children enrolled, who speak either English or Spanish,
and provide parental/guardian permission (informed consent) for their own
participation

- Subject (child) assent

Exclusion Criteria:

- Children / Adolescents:

- Previous nerve block

- Allergy to local anesthetics

- Skull defect or break in the skin at the planned site of cream application or GON
injection

- Use of IV medications to treat current headache flare prior to enrollment

- Any investigational drug use within 30 days prior to enrollment, or 90 days prior
to enrollment for medications targeted at Calcitonin Gene-Related Peptide

- Pregnant or lactating females

- Parents/guardians or subjects who, in the opinion of the Investigator, may be
non- compliant with study schedules or procedures

- Significant adverse event with prior injection or procedure

- New abnormalities on physical or neurological examination

- Newly reported red flags in headache history which prompt investigation for
secondary headache

- Non-English and Non-Spanish speaking

- Non-English speaking with no Spanish interpreter available

- Parents:

- Parents or guardians of children enrolled, who do not speak either English or
Spanish

- Parental/guardian permission and/or subject (child) assent has been declined

- Parents or guardians, who in the opinion of the investigator, may be
non-compliant or unable to complete the questionnaires