Clinical study of botulinum-A toxin in the treatment of sialorrhea in children with cerebral palsy.

OBJECTIVE

To assess the safety and efficacy of intraglandular (parotid and submandibular) botulinum-A toxin (BTX-A) in the treatment of sialorrhea in children with cerebral palsy (CP).

STUDY

DESIGN

Prospective, open-label, dose-escalation study.

SETTING

Tertiary care Children's Hospital.

PATIENTS: Twenty-two subjects between 8 and 21 years of age with CP and significant sialorrhea.

INTERVENTION/TECHNIQUE: The first 12 subjects were injected in only the submandibular gland and the second 10 in the submandibular and parotid glands. Injections were performed under ultrasound localization. The first group (divided into 3) received a total of 10, 20, or 30 units of BTX-A. The second group (divided into 3) received a standard of 30 units in the submandibular gland and 20, 30, or 40 units in the parotid glands.

MAIN OUTCOME MEASURE(S): Drool quantification using a pre- and postinjection "drool rating scale," dental roll weights, and "drool quotient." Swallowing was evaluated pre- and postinjection with a formal speech therapy evaluation.

RESULTS

All subjects successfully underwent BTX-A injections without local or systemic complications. There were no adverse effects on swallowing. Objective "drool quantification" with dental rolls was extremely difficult in this population. Most indicative of results was the "drool rating" questionnaire and the "drool quotient."

CONCLUSIONS

BTX-A is a potentially safe and promising, minimally invasive treatment for sialorrhea in children with cerebral palsy.