Treatment of sialorrhea with glycopyrrolate - A double-blind, dose-rangingstudy

Objective: To determine the safety and efficacy of glycopyrrolate in the tr eatment of developmentally disabled children with sialorrhea. Design: Placebo-controlled, double-blind, crossover dose-ranging study. Setting: Outpatient facilities in 2 pediatric hospitals. Patients: Thirty-n ine children with bo th developmental disabilities and excessive and bother some sialorrhea. Main Outcome Measures: Parent and investigator evaluation of change in sial orrhea and adverse effects. Results: Glycopyrrolate in doses of 0.10 mg/kg per dose is effective at con trolling sialorrhea. Even at low doses, 20% of children may exhibit adverse effects severe enough to require discontinuation. Conclusions: Glycopyrrolate is effective in the control of excessive sialor rhea in children with developmental disabilities. Approximately 20% of chil dren given glycopyrrolate may experience substantial adverse effects, enoug h to require discontinuation of medication.