Treatment of sialorrhea in children with Cerebral Palsy: A double-blind placebo controlled trial

Abstract

Objectives To prospectively study the efficacy and safety of intraparotid gland injection of Botulinum neurotoxin serotype A (Dysport ®) for the treatment of sialorrhea (drooling) in children with cerebral palsy (CP). Patients and methods Twenty-four children, ages 21 months to 7 years, were recruited and randomized to receive either treatment with 100 U Botulinum toxin or placebo. Rating scales for the frequency and severity of drooling were performed at the time of injection, at 1 month, and at baseline prior to the second injection. A second set of injections of either 140 U of drug or placebo was given 4 months later, and the same rating scales were used. Eight patients declined the second injection. Due to high dropouts in the placebo group in second set of injections, statistical analysis was performed for the results of the initial injection only. Results Scores of the median frequency ( p = 0.034) and severity ( p = 0.026) of drooling were reduced in the treatment group. Median total score also declined in the treatment group ( p = 0.027). After the second injection, five out of nine patients injected with the drug showed a decline in the total score; including three patients who did not respond to the first injection. Only two patients experienced transient increase in drooling after the treatment with the drug. Conclusion Botulinum toxin is an effective and safe treatment option for drooling in children with CP.