69 Submandibular Duct Ligation After Botulinum Neurotoxin A Treatment of Drooling in Children With Cerebral Palsy 3 Table 1: Inclusion and exclusion criteria Inclusion criteria Exclusion criteria Age 4–18y Simultaneous medical treatment for drooling Diagnosed with cerebral palsy or non-progressive developmental disorders Simultaneous use of benzodiazepines Severe drooling (Teacher Drooling Scale ≥3)a Treatment with BoNT-A ≤6mo before surgery At least one treatment with BoNT-A in submandibular glands before bilateral submandibular duct ligation Missing baseline value or >1 subsequent missing measurement Treated with bilateral submandibular duct ligation More than 5y between BoNT-A and bilateral submandibular duct ligation aTeacher Drooling Scale: 1, no drooling; 2, infrequent drooling, small amount; 3, occasional drooling, on and off all day; 4, frequent drooling, but not profuse; 5, constant drooling, always wet. BoNT-A, botulinum neurotoxin A. Procedures All participants had previously undergone BoNT-A injections followed by surgery at least 6 months later. Both procedures were performed as part of day care. BoNT-A (Botox; Allergan, Dublin, Republic of Ireland) was administered under general anaesthesia, fractioning 1ml over two or three sites throughout the submandibular gland using a Spinocan needle and ultrasound guidance.6 Surgery was also performed under general anaesthesia. After the floor of the mouth was infiltrated with local anaesthetic and adrenaline, the submandibular ducts were identified through a midline incision parallel to the lingual frenulum. After identification, the duct was freed for 1 to 2cm. Initially, the submandibular ducts were ligated with non-resorbable 3-0 polyester sutures (n=3). From August 2008, metal vascular clips were used as substitutes for ligation (n=26). Vicryl 3-0 intraoral resorbable sutures were used to close the floor of the mouth. Antibiotics (combination of amoxicillin and clavulanate potassium) were prescribed for 7 days and diclofenac for 5 days postoperatively. Outcome measures Drooling was assessed subjectively by caretakers using the Visual Analogue Scale (VAS) for severity of drooling during the 2 weeks before assessment. The assigned drooling score ranged from 0 (no drooling) to 100 (severe drooling) at all visits.
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