To determine the safety and efficacy of glycopyrrolate in the treatment of developmentally disabled children with sialorrhea.
Placebo-controlled, double-blind, crossover dose-ranging study.
Outpatient facilities in 2 pediatric hospitals.
Thirty-nine children with both developmental disabilities and excessive and bothersome sialorrhea.
Main Outcome Measures
Parent and investigator evaluation of change in sialorrhea and adverse effects.
Glycopyrrolate in doses of 0.10 mg/kg per dose is effective at controlling sialorrhea. Even at low doses, 20% of children may exhibit adverse effects severe enough to require discontinuation.
Glycopyrrolate is effective in the control of excessive sialorrhea in children with developmental disabilities. Approximately 20% of children given glycopyrrolate may experience substantial adverse effects, enough to require discontinuation of medication.