Occipital Blocks for Acute Migraine

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    58
  • sponsor
    Children's Hospital of Philadelphia
Updated on 23 May 2021

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.

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 58 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.

Details
Condition Episodic Migraine, Chronic Migraine, Headache
Treatment Normal saline, Lidocaine 4% Topical Application Cream [LMX 4], Lidocaine Hydrochloride 2 mg/mL Injectable Solution
Clinical Study IdentifierNCT03526874
SponsorChildren's Hospital of Philadelphia
Last Modified on23 May 2021

Eligibility

Yes No Not Sure

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 up to 3 months unresponsive to acute medications. Patients who report that acute medications were not used during this headache flare because those medications have 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 pregnancy test
Weight > 25kg
Parents
Parents or guardians of children enrolled, who speak either English or Spanish, and provide parental/guardian permission (informed consent) for their own participation
Subject (child) assent

Exclusion Criteria

Children / Adolescents
Previous nerve block less than 3 months ago or more than 2 previous nerve blocks
Allergy to local anesthetics
Skull defect or break in the skin at the planned site of cream application or GON injection
Any investigational drug use within 30 days prior to enrollment, or 90 days prior 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 be non- 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 for secondary 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 or Spanish
Parental/guardian permission and/or subject (child) assent has been declined
Parents or guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the questionnaires
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note