Occipital Blocks for Acute Migraine

Last updated: March 28, 2025
Sponsor: Children's Hospital of Philadelphia
Overall Status: Completed

Phase

3

Condition

Pain

Migraine (Pediatric)

Pain (Pediatric)

Treatment

Lidocaine Hydrochloride 2 mg/mL Injectable Solution

Normal Saline

Lidocaine 4% Topical Application Cream [LMX 4]

Clinical Study ID

NCT03526874
18-014939
K23NS102521
  • Ages 7-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 upto 3 months unresponsive to acute medications. Patients who report that acutemedications were not used during this headache flare because those medicationshave 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 pregnancytest

  • Weight > 25kg

  • Parents:

  • Parents or guardians of children enrolled, who speak either English or Spanish,and provide parental/guardian permission (informed consent) for their ownparticipation

  • Subject (child) assent

Exclusion

Exclusion Criteria:

  • Children / Adolescents:

  • Previous nerve block less than 3 months ago or more than 2 previous nerveblocks

  • Allergy to local anesthetics

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

  • Any investigational drug use within 30 days prior to enrollment, or 90 daysprior 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 benon- 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 forsecondary 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 orSpanish

  • Parental/guardian permission and/or subject (child) assent has been declined

  • Parents or guardians, who in the opinion of the investigator, may benon-compliant or unable to complete the questionnaires

Study Design

Total Participants: 63
Treatment Group(s): 3
Primary Treatment: Lidocaine Hydrochloride 2 mg/mL Injectable Solution
Phase: 3
Study Start date:
April 03, 2019
Estimated Completion Date:
March 10, 2023

Study 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.

Connect with a study center

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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