Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

Study Overview
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Brief Summary
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A 100 units of botulinum toxin was injected in both parotid and submandibular glands for children (2 - 12 years) with incapacitating sialorrhea in juvenile cerebral palsy patients and they are followed up for 1 year

Detailed Description
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This was a prospective, longitudinal analysis with 1-year follow-up of 52 children with juvenile cerebral palsy (JCP) suffering from sialorrhea enrolled from 3 tertiary pediatric neurology rehabilitation centers (two in Cairo and one in Alexandria) and subjected to repeated BoNT-A injection. The recruitment period was between June 30, 2021, until May 1, 2022 (the last patient follow-up ended on April 30, 2023). Intervention: 100 units of OnabotulinumtoxinA (Botox®) were injected in the parotid and submandibular glands Follow-up visits: mo 1 post-injection (for every injection session) and every 3 months thereafter In each visit; the following efficacy variables were assessed: Primary outcome measures: The severity and frequency of sialorrhea evaluated by Drooling Severity Scale (DSS), and Drooling Frequency Scale (DFS) and visual-analogic ratings of familial distress (VAS-FD). Secondary outcome measure: The carers' Global Impression of Change Scale score measured on a 7-point Likert scale from -3 (very much worse) to +3 (very much improved) Also, adverse events were assessed in each visit

Official Title
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Long-term Follow-up of Safety and Efficacy of OnabotulinumtoxinA for Treatment of Sialorrhea in Juvenile Cerebral Palsy

Conditions
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Sialorrhea

Intervention / Treatment
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* Drug: onaBoNT-A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Juvenile cerebral palsy with age range (4 - 12 years) Having severe drooling (DFS > 4) Signing written informed consent by the legal guardians. Exclusion Criteria: Previous BoNT-A injection in the last three months Patients receiving systemic medicine for the treatment of sialorrhea in the last 6 weeks Any contraindications to treatment with BoNT

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: onaBoNT-A|injection under ultrasonography|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drooling Severity Scale (DSS) and the Drooling Frequency Scale (DFS) | Each patient was assigned a severity rank according to the following grades: 1, dry: never drools; 2, mild: only the lips are wet; 3, moderate: wet on the lips and chin; 4, severe: drools to the extent that clothing becomes damp; 5, profuse: clothing, hands, tray, and objects become wet. The frequency of drooling was also rated as 1, never drools; 2, occasional drooling; 3, frequent drooling; and 4, constant drooling. The final drooling score is the summed ranking across both scales together to make a combined drooling ranking from 2 to 9. | 1 year |