Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the effectiveness of botulinum toxin in treatment of drooling
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.
详细描述
Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side 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
- Double
入排标准
- 年龄范围
- 6 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of cerebral palsy
- •severe drooling
- •aged 6-21 yrs
- •subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form
排除标准
- •age below 6 yrs or above 21 yrs
- •known allergy or sensitivity to the study medication or its component
- •diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
- •subjects who have prior surgery of the submandibular gland
- •subjects who are receiving medication that affect drooling such as anticholinergic drug
- •inability to give informed consent
结局指标
主要结局
the effectiveness of botulinum toxin in treatment of drooling
次要结局
- the most appropriated dosage of treatment
- duration of effect
- side effects
