42 CHAPTER 2 ABSTRACT Objective To compare the effect of submandibular Duct Ligation (2-DL) and submandibular Botulinum neurotoxin type A (BoNT-A) for drooling in children and adolescents with neurodevelopmental disabilities. Methods A randomized, interventional, controlled, and partly single-blinded study (trialregister.nl identifier NTR3537) was performed in which submandibular BoNT-A was compared with 2-DL to treat excessive drooling. Main outcomes included a Visual Analogue Scale (VAS), drooling quotient (DQ) and drooling severity and frequency scale (DS/DF scale. Each was obtained at baseline, and 8 and 32 weeks post-treatment. Results 57 patients (mean age: 11 years, mean baseline VAS 7.9, mean baseline DQ 27.3%) were randomized to 2-DL or BoNT-A. Four patients were excluded from analyses, leaving 53 patients for intention to treat analyses. Response to treatment, defined as a ≥50% reduction in DQ or VAS, was higher for 2-DL after 32 weeks (63.0% vs 26.9%, p = 0.008). Both VAS (24.5, p < 0.001) and DQ (-9.3%, p = 0.022) were significantly lower at follow-up after 2-DL vs BoNT-A. The total amount of adverse events (p = 0.088, 40.7% vs. 19.2%) and postoperative complaints were higher (p < 0.001, mean 9.6 vs. 3.6 days) for 2-DL than for BoNT-A. Conclusion 2-DL is a more effective treatment for drooling than botulinum toxin, but carries a slightly greater risk for complications and morbidity. Classification of evidence This study provides Class III evidence that for children and adolescents with neurodevelopmental disabilities and severe drooling, 2-DL compared to a one-time intraglandular BoNT-A injection is more effective at reducing drooling at 32 weeks.
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