45 Randomized controlled trial comparing botulinum versus surgery for drooling in neurodisabilities 2 4. Ability and willingness to follow the study protocol and attend the 8 and 32-weeks visits. 5. Written and informed consent from caregivers, and when appropriate, oral consent from the child. Patients with potentially progressive oro-motor impairment, those who were receiving medical treatment (glycopyrrolate or scopolamine) at the time of inclusion, those with a surgical history intervening with 2-ductligation (2-DL), those with any other contraindication for general anesthesia, BoNT-A injections or surgery, or those who used benzodiazepines, were excluded from the study. Concurrent use of benzodiazepines was part of the exclusion criteria because of potential influences on the swallowing process, thus causing increased drooling, particularly at high doses.16 Interventions. After baseline assessment, patients were randomized to BoNT-A or 2-DL. Onabotulinum toxin A (25 U in 0.9% saline per submandibular salivary gland; Botox; Allergan; Nieuwegein, the Netherlands), was administered under general anesthesia in a single procedure using ultrasonographic guidance with a 25-gauge needle and a 1-mL syringe.17 Only the submandibular glands were injected. In our institution, combined BoNT-A injections in both the submandibular and the parotid glands are generally only considered if there has been insufficient response to submandibular injections.18 2-DL was also performed under general anesthesia. The floor of the mouth was infiltrated with 1% lidocaine with 1:100.000 epinephrine, and incised parallel to the frenulum. After identification of the duct, it was dissected for 1 to 2 cm and ligated using a disposable stapler, applying two vascular clips per duct. The incision was closed with absorbable sutures. Both procedures were performed in an outpatient setting, and all patients allocated to 2-DL received antibiotics (amoxicillin/clavulanic acid) for 7 days and analgesics (paracetamol and diclofenac) for 5 days postoperatively. Randomization. Patients were randomly assigned by the research associates in a 1:1 ratio using a centrally held, statistician primed, computer generated
RkJQdWJsaXNoZXIy MjY0ODMw