title: Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study.
abstract: The aim of this prospective open-label study was to treat disabling drooling in children with cerebral palsy (CP) with onabotulinumtoxin A (A/Ona, Botox®) into submandibular and parotid glands and find the lowest effective dosage and least invasive method. A/Ona was injected in 14 children, Mean age 9 years, SD 3 years, under ultrasonic guidance in six successive Series, with at least six months between injections. Doses and gland involvement increased from Series A to F (units (U) per submandibular/parotid gland: A, 10/0; B, 15/0; C, 20/0; D, 20/20; E, 30/20; and F, 30/30). The effect was assessed 2, 4, 8, 12, and 20 weeks after A/Ona (drooling problems (VAS), impact (0-7), treatment effect (0-5), unstimulated whole saliva (UWS) flow and composition)) and analyzed by two-way ANOVA. The effect was unchanged-moderate in A to moderate-marked in F. Changes in all parameters were significant in E and F, but with swallowing problems ≤5 weeks in 3 of 28 treatments. F had largest VAS and UWS reduction (64% and 49%). We recommend: Start with dose D A/Ona (both submandibular and parotid glands and a total of 80 U) and increase to E and eventually F (total 120 U) without sufficient response.
authors.affiliation: Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen DK-2200, Denmark. eigild.moller@gmail.com.|Department of Neurology, Bispebjerg University Hospital, Copenhagen DK-2400, Denmark. eigild.moller@gmail.com.
authors.forename: Eigild
authors.initials: E
authors.lastname: Møller
authors.affiliation: Departments of Pediatrics and Radiology, Hvidovre University Hospital, Hvidovre DK-2650, Denmark. sap@dadlnet.dk.
authors.forename: Søren Anker
authors.initials: SA
authors.lastname: Pedersen
authors.affiliation: Departments of Pediatrics and Radiology, Hvidovre University Hospital, Hvidovre DK-2650, Denmark. pablo.gustavo.vinicoff@regionh.dk.
authors.forename: Pablo Gustavo
authors.initials: PG
authors.lastname: Vinicoff
authors.affiliation: Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen DK-2200, Denmark. alba@sund.ku.dk.
authors.forename: Allan
authors.initials: A
authors.lastname: Bardow
authors.affiliation: Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen DK-2200, Denmark. jsly@sund.ku.dk.
authors.forename: Joan
authors.initials: J
authors.lastname: Lykkeaa
authors.affiliation: Gerbrandskolen, Copenhagen Municipal Dental Service, Copenhagen DK-2300, Denmark. piasvendsen42@gmail.com.
authors.forename: Pia
authors.initials: P
authors.lastname: Svendsen
authors.affiliation: Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen DK-2200, Denmark. mbak@sund.ku.dk.
authors.forename: Merete
authors.initials: M
authors.lastname: Bakke
mesh_terms: D000293:Adolescent; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000150:complications / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D010306:Parotid Gland / Q000187:drug effects; D011446:Prospective Studies; D012798:Sialorrhea / Q000209:etiology / Q000517:prevention & control*; D013363:Submandibular Gland / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D019274:Botulinum Toxins, Type A
keywords: botulinum toxin; cerebral paresis; children; drooling; salivary flow