Tolerance of salivary gland botulinum toxin A injection under local anesthesia for the treatment of sialorrhea in children: An observational study.

OBJECTIVES: The main objective of this study was to assess tolerance of botulinum toxin A injection into the salivary glands under local anesthesia in a pediatric population. Secondary endpoints comprised efficacy and side-effects. MATERIAL AND METHODS: A retrospective observational study included children treated between January 2013 and March 2020 for sialorrhea and/or pharyngeal salivary congestion. Children were identified from the botulinum toxin A injection database. The study included 162 injection sessions in 55 children. Injections were performed under local anesthesia with nitrous oxide, after clinical location of the site. Epidemiological and clinical data, injection tolerance on the FLACC scale, treatment response and complications were recorded. RESULTS: For submandibular gland injections, pain was absent in 81 cases, mild in 64, moderate in 4 and intense in 1. In parotid gland injections, pain was absent in 45 cases, mild in 89, moderate in 17 and intense in 1. Injection tolerance was significantly poorer (P<0.005) in parotid than submandibular glands. Seventy-seven percent of the injections had a positive effect on sialorrhea. Fifteen patients presented transient adverse events: mainly dysphagia and paradoxical increase in sialorrhea. CONCLUSION: Salivary gland botulinum toxin A injections in under local anesthesia were well-tolerated, safe and effective for children with sialorrhea and/or pharyngeal salivary congestion.