Occipital Blocks for Acute Migraine
Condition: Chronic Migraine, Headache; Episodic Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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 194 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.
    

Intervention name(s): Lidocaine 4% Topical Application Cream [LMX 4]; Lidocaine Hydrochloride 2 mg/mL Injectable Solution; Normal Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): 0.9% Sodium Chloride
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind greater occipital nerve injection of lidocaine versus saline after open-label lidocaine cream run-in
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Chronic Migraine; Episodic Migraine; Headache; Nerve Block