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December 2000

Treatment of Sialorrhea With Glycopyrrolate: A Double-blind, Dose-Ranging Study

Author Affiliations

From the Shriners Hospital for Children, Lexington, Ky (Dr Mier, Mr Lakin, and Ms Barker), and the Alfred I. duPont Hospital for Children, Wilmington, Del (Drs Bachrach and Childs and Ms Moran).

Arch Pediatr Adolesc Med. 2000;154(12):1214-1218. doi:10.1001/archpedi.154.12.1214

Objective  To determine the safety and efficacy of glycopyrrolate in the treatment of developmentally disabled children with sialorrhea.

Design  Placebo-controlled, double-blind, crossover dose-ranging study.

Setting  Outpatient facilities in 2 pediatric hospitals.

Patients  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.

Results  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.

Conclusions  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.