Occipital Blocks for Acute Migraine

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.

Conditions

• Chronic Migraine, Headache
• Episodic Migraine

Interventions

DRUG

Lidocaine 4% Topical Application Cream [LMX 4]

Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.

DRUG

Lidocaine Hydrochloride 2 mg/mL Injectable Solution

Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment.

DRUG

Normal Saline

Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Children's Hospital of Philadelphia

  lead OTHER

Principal Investigators

• Christina L. Szperka, MD, MSCE · Children's Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-03

Primary Completion

2023-03-10

Completion

2023-03-10

FDA Drug

Yes

Countries

• United States

Study Locations