At a glance
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Occipital Nerve Blocks for Acute Treatment of Pediatric Migraine
In Brief
A Phase 3 clinical trial evaluating Lidocaine 4% Topical Application Cream [LMX 4], Lidocaine Hydrochloride 2 mg/mL Injectable Solution, and 1 other intervention for Chronic Migraine, Headache and Episodic Migraine. Completed, enrolled 63 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment.
Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator.