Botox(®) to reduce drooling in a paediatric population with neurological impairments: a Phase I study.

BACKGROUND: The treatment of drooling in a paediatric population with neurological impairments is clinically challenging. Surgery is considered invasive, while behaviour modification techniques, correction of situational factors and oral-motor therapy do not always produce sustained improvement. In recent years the use of Botox® to decrease drooling has been investigated.

AIMS: To review the clinical data from a Drooling Treatment Project for children with neurological impairments and to establish the validity of the drooling severity and frequency rating scales, establishing Phase I-level information about the therapeutic use of submandibular salivary gland injections of Botox® in various contexts.

METHOD & PROCEDURES: A retrospective, explanatory design was used to review the data. Nine children, seven with cerebral palsy and two with operculum syndrome, ranging in age from 5 to 17 years (mean = 9;3 years) were included. Drooling was assessed by qualified speech-language therapists using drooling rating scales, in five different situations and at different time points pre- and post-Botox® injection up to 6 months. Quantitative and qualitative analyses were computed. Parents'/primary caregivers' perceptions of drooling and treatment with Botox® were also considered using an interview form and a quality of life questionnaire.

OUTCOMES & RESULTS: Statistically significant reductions in drooling with large effect sizes were obtained in the communicating and general appearance situations. There was a difference in the pattern of response between the children with cerebral palsy and those with operculum syndrome. Discrepancies between the parents and the speech-language therapists regarding the context of drooling reduction were found. Most parents/primary caregivers felt their children's lives and their own had improved following the Botox® injection and would repeat the treatment. The drooling rating scales were a valid method to assess drooling in a clinical situation.

CONCLUSIONS & IMPLICATIONS: In the clinical setting of the Drooling Treatment Project, the results indicated that the context in which drooling occurs is an important factor and suggested the value of considering the situational context when making drooling judgments. Further, there was a difference in the pattern of response between the children with cerebral palsy and those with operculum syndrome, suggesting that aetiology may be involved in the response to Botox®.