43 Randomized controlled trial comparing botulinum versus surgery for drooling in neurodisabilities 2 INTRODUCTION Drooling is a common problem in children with Cerebral Palsy (CP) and other neurodevelopmental disabilities as approximately 40% of the children with CP suffer from drooling. Drooling is a disabling condition associated with physical and emotional distress.2-4 Current treatment and its limitations If drooling proves refractory to conservative treatment (speech or behavioral therapy), or patients are ineligible for conservative or systemic treatment, intraglandular botulinum neurotoxin type A (BoNT-A) can be considered.5 Injected under general anesthesia, it is effective in approximately 50% of children for a median of 22 weeks.3 Botulinum toxin by nature only has a limited duration of effect. If drooling persists despite repeated injections, patients and caregivers often express a desire for a more permanent solution. Surgical techniques such as Submandibular Gland Excision (SMGE) and Submandibular Duct Relocation (SMDR) are effective in a majority of patients.6-10 Both have several downsides, however: SMGE is associated with external scars, while SMDR is a more technically challenging procedure and is contraindicated in posterior drooling.11-13 Both procedures are also associated with significant operative time and, in the case of SMDR, require several days hospitalization. Submandibular Duct Ligation (2-DL) recently gained popularity as a minimally invasive, simple and short procedure with limited dissection and peri-operative morbidity that appears to rival BoNTinjections.14 However, the effectiveness of 2-DL is less well-established than SMDR and SMGE. This randomized clinical trial compares the effect of 2-DL to BoNT-A for drooling in children and adolescents with neurodevelopmental disabilities. METHODS Trial design The study was designed as a randomized controlled trial. In the early stage of
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