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Treatment of sialorrhea with glycopyrrolate: A double-blind, dose-ranging study
R J Mier1, S J Bachrach, R C Lakin
1Shriners Hospital for Children, 1900 Richmond Rd, Lexington, KY 40502, USA. rjmier@aol.com
Insights
Glycopyrrolate effectively controls sialorrhea in children with developmental disabilities. However, about 20% of these children may experience significant adverse effects requiring medication discontinuation.
Area of Science:
- Pediatric pharmacology
- Neurodevelopmental disorders
- Salivary gland dysfunction
Background:
- Sialorrhea, or excessive drooling, is a common challenge in children with developmental disabilities.
- Effective management strategies are crucial for improving quality of life and preventing complications.
Purpose of the Study:
- To evaluate the safety and efficacy of glycopyrrolate for treating sialorrhea in developmentally disabled children.
- To determine optimal dosing and identify potential adverse effects.
Main Methods:
- A placebo-controlled, double-blind, crossover, dose-ranging study was conducted.
- Thirty-nine children with developmental disabilities and bothersome sialorrhea participated.
- Outcomes were assessed via parent and investigator evaluations of sialorrhea reduction and adverse events.
Main Results:
- Glycopyrrolate demonstrated efficacy in controlling sialorrhea at a dose of 0.10 mg/kg per administration.
- A significant proportion of children (20%) experienced adverse effects necessitating treatment cessation, even at low doses.
Conclusions:
- Glycopyrrolate is an effective treatment for excessive sialorrhea in pediatric patients with developmental disabilities.
- Clinicians should be aware of the potential for substantial adverse effects in approximately 20% of treated children.
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.