{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T02:53:13Z","timestamp":1771296793648,"version":"3.50.1"},"reference-count":21,"publisher":"BMJ","issue":"1","funder":[{"DOI":"10.13039\/100002605","name":"American Society of Regional Anesthesia and Pain Medicine","doi-asserted-by":"publisher","award":["Chronic Pain Research Grant"],"award-info":[{"award-number":["Chronic Pain Research Grant"]}],"id":[{"id":"10.13039\/100002605","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["Reg Anesth Pain Med"],"accepted":{"date-parts":[[2020,9,15]]},"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>OnabotulinumtoxinA (OBTA) is approved for treating chronic headaches and migraines in adults, but there is limited scientific literature on the outcomes in pediatric patients. The aim of this study was to determine if subjects treated with OBTA reported a statistically significant improvement in the primary features (frequency, intensity, duration and disability scoring) associated with migraines compared with placebo at follow-up visits.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>After obtaining approval by the appropriate local (HS# 2016\u20133108) and federal institutions, the principal investigator enrolled candidates aged 8 to 17 years old diagnosed with chronic migraines (at least 6 months), and 15 or more headache days in a 4-week baseline period. This randomized control trial consisted of two phases: double-blind and open-label for the first two and last two sets of treatments, respectively. Subjects were randomly assigned to receive a treatment protocol\u2014155 units at 31 injection sites\u2014in 3-month intervals and follow-up visits every 6 weeks. Non-parametric testing (Wilcoxon signed-rank test) was performed using widely available open-source statistical software (\u2018R\u2019).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From February 2017 to November 2018, 17 subjects presented for a screening visit; 15 met eligibility criteria. Subjects that received OBTA reported a statistically significant decrease from the following baseline values compared with placebo 6-week post-treatment compared with placebo: frequency (20 (7 to 17) vs 28 (23 to 28); p=0.038), intensity (5 (3 to 7) vs 7 (5 to 9); p=0.047), and PedMIDAS (Pediatric Migraine Disability Score) (3 (2 to 4) vs 4 (4 to 4); p=0.047). There was no statistically significant difference in the duration (10 (2 to 24) vs 24 (4 to 24); p=0.148) of migraines between the two groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>OnabotulinumtoxinA showed a statistically significant decrease in frequency and intensity of migraines compared with placebo. No adverse effects or serious adverse events related to the use of OBTA were reported. In the future, we aim to evaluate the specific nature of migraines, for example, quality\/location of pain presented during an initial consult to predict the likelihood of OBTA being a truly effective modality of pain management for pediatric migraineurs.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03055767\">NCT03055767<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rapm-2020-101605","type":"journal-article","created":{"date-parts":[[2020,10,26]],"date-time":"2020-10-26T17:11:10Z","timestamp":1603732270000},"page":"41-48","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":32,"title":["Effectiveness of onabotulinumtoxinA (BOTOX) in pediatric patients experiencing migraines: a randomized, double-blinded, placebo-controlled crossover study in the pediatric pain population"],"prefix":"10.1136","volume":"46","clinical-trial-number":[{"clinical-trial-number":"nct03055767","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Shalini","family":"Shah","sequence":"first","affiliation":[{"name":"Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael-David","family":"Calderon","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nikhil","family":"Crain","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason","family":"Pham","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Rinehart","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology & Perioperative Care, University of California Irvine Health, Orange, CA, 92868"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,10,26]]},"reference":[{"key":"2025101112163066000_46.1.41.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pediatrneurol.2010.06.001"},{"key":"2025101112163066000_46.1.41.2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0032-1330856"},{"key":"2025101112163066000_46.1.41.3","doi-asserted-by":"crossref","first-page":"1247","DOI":"10.1007\/s12098-010-0210-2","article-title":"Profile of children with migraine","volume":"77","author":"Aydin","year":"2010","journal-title":"Indian J Pediatr"},{"key":"2025101112163066000_46.1.41.4","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1016\/j.ejpn.2015.09.011","article-title":"Evaluation and management of vestibular migraine in children: experience from a pediatric vestibular clinic","volume":"20","author":"Brodsky","year":"2016","journal-title":"Eur J Paediatr Neurol"},{"key":"2025101112163066000_46.1.41.5","doi-asserted-by":"publisher","DOI":"10.1016\/0304-3959(94)00210-6"},{"key":"2025101112163066000_46.1.41.6","doi-asserted-by":"publisher","DOI":"10.1111\/head.12105"},{"key":"2025101112163066000_46.1.41.7","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2011.01990.x"},{"key":"2025101112163066000_46.1.41.8","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2010.01678.x"},{"key":"2025101112163066000_46.1.41.9","doi-asserted-by":"crossref","first-page":"35","DOI":"10.2147\/NDT.S17923","article-title":"Critical analysis of the use of onabotulinumtoxinA (botulinum toxin type A) in migraine","volume":"8","author":"Robertson","year":"2012","journal-title":"Neuropsychiatr Dis Treat"},{"key":"2025101112163066000_46.1.41.10","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1055\/s-0032-1329612","article-title":"Ten-Year follow-up in a case series of integrative botulinum toxin intervention in adolescents with chronic daily headache and associated muscle pain","volume":"43","author":"Schroeder","year":"2012","journal-title":"Neuropediatrics"},{"key":"2025101112163066000_46.1.41.11","doi-asserted-by":"crossref","DOI":"10.1007\/s11916-015-0536-6","article-title":"Prophylactic drug treatment of migraine in children and adolescents: an update","volume":"20","author":"Tajti","year":"2016","journal-title":"Curr Pain Headache Rep"},{"key":"2025101112163066000_46.1.41.12","unstructured":"Michael-David Calderon BS , Wei Der Wu BS , Michael Ma BS , et al . 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