Ipratropium Bromide Spray as Treatment for Sialorrhea in Children: a Randomized, Double-blind, Placebo-controlled Crossover Study
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 主要终点
- Change in Drooling Severity and Frequency Scale
研究概览
简要总结
Double-blind, clinical trial investigating the effects of ipratropium spray versus placebo spray in children with sialorrhea
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 5-18 with a history of excessive drooling
排除标准
- •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
研究组 & 干预措施
Intervention
ipratropium bromide administered via metered dose spray (21 micrograms per spray). 1-2 spray sublingual or to buccal mucosa every 6 hours up to 4 times a day
干预措施: Ipratropium bromide (Drug)
Placebo
normal saline administered via metered dose spray. 1-2 spray sublingual or to buccal mucosa every 6 hours up to 4 times a day
干预措施: Placebo (Other)
结局指标
主要结局
Change in Drooling Severity and Frequency Scale
时间窗: 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
时间窗: 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.
次要结局
- Patient Global Impression of Improvement Scale(At start of trial and weekly self recording up to 8 weeks)
- Adverse effect(Intermittent up to 8 weeks)
- Patient feedback(Weekly self recording up to 8 weeks.)
研究者
Peng You
Principle Investigator, Department of Otolaryngology Head and Neck Surgery, Western University
London Health Sciences Centre