Occipital Blocks for Acute Migraine

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Migraine affects 10-28% of children and adolescents and yet 20-30% of patients are ineffectively treated with current oral and nasal options. Peripheral nerve blocks (PNBs), injections of local anesthetics over branches of the occipital and/or trigeminal nerves, have been associated with possible benefit for pediatric headaches in case series, and may be useful for both acute and preventive treatment of migraine for children who fail less invasive treatments. In fact, 80% of pediatric headache specialists reported using peripheral nerve blocks and carry low risk of serious side effects; however, peripheral nerve blocks have never been tested, formally, in a randomized pediatric trial.

By applying a novel design that utilizes lidocaine cream as a run-in step, investigators intend to test the efficacy of the most commonly used peripheral nerve block, the greater occipital nerve (GON) block, as an acute treatment for pediatric migraine and determine whether lidocaine cream leads to successful blinding of the injection.

The GON block is expected to prove effective in decreasing the pain of migraine, with lidocaine being superior to saline and lidocaine cream maintaining blinding.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Children / Adolescents:

• Males or females, ages 7 - 21, of any gender, race, or ethnicity

• Diagnosis of episodic or chronic migraine with acute headache flare lasting up to 3 months unresponsive to acute 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 less than 3 months ago or more than 2 previous nerve blocks

• Allergy to local anesthetics

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

• 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