Treatment of sialorrhea in children with cerebral palsy: a double-blind placebo controlled trial.
OBJECTIVE
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).


METHODS
Twenty-four children, ages 21 months to 7 years, were recruited and randomized to receive either treatment with 100U 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 140U 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.


CONCLUSIONS
Botulinum toxin is an effective and safe treatment option for drooling in children with CP.
Alrefai
Ali H
AH
Jordan University of Science and Technology, Jordan.
Aburahma
Samah K
SK
Khader
Yousef S
YS
D018726:Anti-Dyskinesia Agents / Q000008:administration & dosage / Q000627:therapeutic use; D001905:Botulinum Toxins / Q000008:administration & dosage / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000150:complications*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010306:Parotid Gland / Q000187:drug effects / Q000503:physiopathology; D011446:Prospective Studies; D012463:Saliva / Q000187:drug effects / Q000378:metabolism; D012798:Sialorrhea / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D016896:Treatment Outcome
D018726:Anti-Dyskinesia Agents; D001905:Botulinum Toxins