64 CHAPTER 3 ABSTRACT Aim To assess: (1) the effect on drooling of bilateral submandibular duct ligation as surgical therapy after the administration of submandibular botulinum neurotoxin A (BoNT-A) for excessive drooling and (2) the predictive value of treatment success with BoNT-A on treatment success after bilateral submandibular duct ligation. Methods This was a within-participant retrospective observational study in which 29 children with severe drooling (15 males, 14 females) received BoNT-A treatment at a mean age of 9 years 6 months (SD 2y 5mo), followed by bilateral submandibular duct ligation at a mean age of 10 years 11 months (SD 2y 4mo). Fifteen children were diagnosed with cerebral palsy (CP), with 12 children classified in Gross Motor Function Classification System levels IV and V. The 14 children without CP had nonprogressive developmental disorders. The primary drooling severity outcomes were the Visual Analogue Scale (VAS; subjective assessment) and drooling quotient (objective assessment). Measurements were taken before each intervention and again at 8 and 32 weeks. Results The VAS was significantly lower after bilateral submandibular duct ligation at followup compared to BoNT-A treatment (mean difference −33, p≤0.001; 95% confidence interval [CI]=−43.3 to −22.9). The mean drooling quotient did not significantly differ between BoNT-A treatment and bilateral submandibular duct ligation at follow-up (3.3, p=0.457; 95% CI=−4.35 to 9.62) or between 8 and 32 weeks (4.7, p=0.188; 95% CI=−2.31 to 11.65). Interpretation BoNT-A treatment and bilateral submandibular duct ligation are both effective treatment modalities for drooling. At 32 week follow-up, subjective drooling severity after bilateral submandibular duct ligation was significantly lower compared to
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