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

Arch Pediatr Adolesc Med. 2000 Dec;154(12):1214-8. doi: 10.1001/archpedi.154.12.1214.

Abstract

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. Arch Pediatr Adolesc Med. 2000;154:1214-1218.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Child, Preschool
  • Cross-Over Studies
  • Developmental Disabilities / complications*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Glycopyrrolate / adverse effects
  • Glycopyrrolate / therapeutic use*
  • Humans
  • Muscarinic Antagonists / adverse effects
  • Muscarinic Antagonists / therapeutic use*
  • Sialorrhea / complications*
  • Sialorrhea / drug therapy*

Substances

  • Muscarinic Antagonists
  • Glycopyrrolate