Ipratropium Bromide Spray as Treatment for Sialorrhea in Children

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London Health Sciences Centre
• Treatments: Bromides; Ipratropium

Criteria

Inclusion Criteria:

• Children and adolescents aged 5-18 with a history of excessive drooling

Exclusion Criteria:

• known hypersensitivity to ipratropium bromide

• surgery for sialorrhea within one year

• the concurrent use of acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents

• botulinum toxin for drooling within the preceding six months

• a history of glaucoma

• the presence of clinically significant urinary retention or outflow obstruction as evidenced by patient history or documented urodynamic studies