Botulinum Toxin Injection for Sialorrhea in Cerebral Palsy

Cairo University (CU)

Status: Completed

Conditions: Sialorrhea

Treatments: Drug: onaBoNT-A

Study type: Observational

Funder types: Other

Identifiers

NCT06101160

BTX-S-JCP

Details and patient eligibility

About

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

Full description

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

Enrollment: 61 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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