BOSTON – Hope may be on the horizon for children and teens who suffer from migraine headaches that don’t respond to traditional treatment. Injections of botulinum toxin (BOTOX®) may provide significant relief, suggests a small preliminary study presented at the
ANESTHESIOLOGY® 2017 annual meeting.
Currently, BOTOX® is approved by the U.S. Food and Drug Administration (FDA) only to treat migraines in adults. One in 10 school-aged children and teens suffer from migraines, but there are few FDA-approved medications for this age group. Additionally, some children and teens don't respond well to available options, such as certain migraine "rescue" pain medications, and the pain and disability of migraines can have a severe impact on their lives. In some cases, preventative medications may help. However, currently only one preventative migraine medication, topiramate, is approved for adolescents.
“When children and teens have migraine pain, it can severely affect their lives and ability to function. They miss school, their grades suffer and they are left behind, often unable to reach their full potential. Clearly there is a need for an alternative treatment for those who haven’t found relief,” said Shalini Shah, M.D., lead author of the study and chief of the Division of Pain Medicine at the University of California, Irvine. “After treatment, we saw improvement in functional aspects in all of the children and teens. In fact, one patient was hospitalized monthly for her migraine pain prior to BOTOX® treatment and was expected to be held back in school. After treatment, she only has one or two migraines a year, and is excelling in college.”
The study included nine children and teens (ages 8 to 17) who suffered from migraines from 8 to 29.5 days per month. Most had tried numerous medications and other therapies without much relief. All received BOTOX® injections in the front and back of the head and neck every 12 weeks and were evaluated over a five-year period. After treatment, the patients experienced migraines 2 to 10 days per month. Additionally, when they did have migraines:
- Their headaches didn’t last nearly as long. Patients’ migraines lasted 30 minutes to 24 hours before treatment and lasted 15 minutes to 7 hours after treatment with BOTOX®.
- Their headaches weren’t as painful. Patient-reported pain on a scale of 1-10 (from no pain to worst pain imaginable) ranged from 4 to 8 before treatment and 1.75 to 5 after treatment with BOTOX®.
Eight adverse events were reported during the study, most were due to pain at the injection site. No severe adverse events were reported.
If the results of the current study are confirmed, BOTOX® could provide an alternative for those without treatment options, said Dr. Shah. Her team currently is enrolling patients to study this treatment in a prospective, randomized double-blinded trial to compare BOTOX® to a placebo.
“Many current migraine medications have side effects including sedation, dry mouth and confusion, which aren’t well-tolerated in children and teens,” said Dr. Shah. “Our research of BOTOX® is part of an effort to find better treatments for children and teens with migraines so they can realize their full potential.”
More information on the randomized trial can be found at
ClinicalTrials.gov. (NCT03055767)
The study authors received no funding from the manufacturer of BOTOX®.
THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS
Founded in 1905, the American Society of Anesthesiologists (ASA) is an educational, research and scientific society with more than 52,000 members organized to raise and maintain the standards of the medical practice of anesthesiology. ASA is committed to ensuring that physician anesthesiologists evaluate and supervise the medical care of patients before, during, and after surgery to provide the highest quality and safest care that every patient deserves.
For more information on the field of anesthesiology, visit the American Society of Anesthesiologists online at asahq.org. To learn more about the role physician anesthesiologists play in ensuring patient safety, visit asahq.org/WhenSecondsCount. Join the ANESTHESIOLOGY® 2017 social conversation today. Like ASA on Facebook, follow ASALifeline on Twitter and use the hashtag #ANES17.
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