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