Sialorrhea
Conditions
Keywords
Ipratropium bromide, Sialorrhea, Pediatric
Brief summary
Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea
Detailed description
Excess drooling, or sialorrhea, is a chronic problem seen in pediatric patients with oral-motor dysfunction or neurodevelopmental abnormalities. Despite significant social and physical detriment from sialorrhea, an effective and safe treatment remains elusive. The investigator's objective is to study the effect of sublingual ipratropium (an anticholinergic aerosol spray) on sialorrhea in the pediatric population Method: A double-blind, randomized, placebo-controlled cross-over trial of sublingual ipratropium bromide application in pediatric patients with inappropriate drooling. Patients are recruited from the sialorrhea clinic and informed consent is obtained. Patients are randomized to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micrograms per metered dose) or matching placebo, every 6 hours up to a maximum of 4 times per day, in a double-blind, cross-over design using randomization tables. Total treatment length is two weeks for each limb of the study with a 2 week washout period. The primary outcome measure is the reporting of sialorrhea using a validated scales. Secondary outcome includes global assessment of treatment, patient satisfaction, and adverse effects.
Interventions
DRUGIpratropium bromide
ipratropium bromide via metered dose spray (21 micrograms per spray)
OTHERPlacebo
normal saline delivered via metered dose spray
Sponsors
London Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study drug will be dispensed as a metered-dose spray bottle of ipratropium bromide or identical placebo prepared by the Hospital Pharmacy. Clinician, investigator, care provider, as well as outcome assessor will be blinded to the treatment.
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Drooling Severity and Frequency Scale | Change from baseline sialorrhea at 2 weeks following each treatment arm | Also referred to as the Thomas Stonell and Greenberg scale. This is a validated tool using patient reported scores for drooling severity and frequency. Drooling severity is scored on a scale with minimum value of 1 and maximum value of 5. A higher value represents a worse outcome. The frequency is scored on a scale with minimum value of 1 and maximum value of 4. A higher value represents a worse outcome. The subscales (severity and frequency) can be interpreted independently or combined through addition to compute a total score. |
| Change in Drooling impact scale | Change from baseline sialorrhea at 2 weeks following each treatment arm | The drooling impact scale is a validated self-administered questionnaire used to measure saliva-control in children. The scale consists of 10 questions/subscales, each with a minimum score of 1 and a maximum score of 10. For all subscales, the higher value represents a worse outcome. The total score is reported and is calculated by adding the score of all 10 subscales. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Impression of Improvement Scale | At start of trial and weekly self recording up to 8 weeks | The Patient Global Impression of improvement scale is a single 7-point scale that requires the patient/caregiver to assess how much the illness has improved or worsened relative to a baseline state at the beginning of the intervention. The minimum score is 1 and the maximum score is 7. A higher value represents a worse outcome. To be collected through patient booklet |
| Adverse effect | Intermittent up to 8 weeks | Documentation of all adverse effects encountered during study period |
| Patient feedback | Weekly self recording up to 8 weeks. | Open ended patient comment related to the intervention. To be collected through patient booklet |
Contacts
Primary ContactJulie Strychowsky, MD
Backup ContactAgnieszka Dzioba, PhD
Outcome results
None listed