A comparative study on efficacy between ultrasound-guided botulinum toxin type a injection to salivary glands and oral glycopyrrolate therapy for management of sialorrhea in cerebral palsy

Objective of proposed research:

To observe separate efficacy between ultrasound guided botulinum toxin type A injection to salivary glands (parotid and submandibular) and oral Glycopyrrolate therapy for management of sialorrhea in children with cerebral palsy and compare between them.

Background of present study:

 It is noted in our regular practice that sialorrhea is one of the common presentations in children

with cerebral palsy. Around (15-20%) of physically disabled children are affected by Cerebral Palsy (CP). In India, the estimated incidence is around 3/1000 live births. CP is associated with many comorbidities including sialorrhea. The most common cause of sialorrhea in children is cerebral palsy with an incidence rate of approximate (10 to 58%).

There are a lot of approaches to manage sialorrhea including behavioural interventions, oral and topical medications, radiation therapy and surgery. However, there is currently no satisfactory solution. The use of oral anticholinergic medication like glycopyrrolate is also limited because of several side effects although it has faster onset of action. As sialorrhea is very much difficult to control with this already existing therapy including oral pharmacological therapy. Hence the need for intervention rises.

The application of ultrasound guided botulinum toxin type A injection to salivary glands (parotid and submandibular) has been shown to be a safe and effective option to treat children with moderate and severe sialorrhea, improving quality of life physically and psychologically. But the efficacy of botulinum toxin injection over oral glycopyrrolate is not properly established and very few literatures have been found. with.So, in this study we will aim to clarify whether Botulinum toxin type A injection has additional value over oral glycopyrrolate therapy for management of sialorrhea in cerebral palsy patients.

 6.      Methodology**:**

 a. Study design: Parallel group, Open label, Randomized Controlled Trial.

 b. Study duration: 18 months.

c. Place of study: Department of Physical Medicine & Rehabilitation (PM&R), IPGME&R and SSKM Hospital, Kolkata.

 d. Study Population: Patients attending OPDs and admitted in IPDs of Department of PM&R fulfilling inclusion and exclusion criteria.

 e. Sample Size: Total 44(22 in each group).

 7.   Expected outcome**:**

Application of ultrasound guided botulinum toxin type A injection to salivary glands (b/l parotid and submandibular) is a better and safe alternative method for management of sialorrhea over existing methods of therapy including oral glycopyrrolate in cerebral palsy patients.