2-duct ligation versus botulinum toxin injections for severe drooling in children with cerebral palsy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22435

Enrollment

Registered

2012-07-23

Start date

2012-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral palsy, drooling, sialorrhea, duct ligation, botulinum toxin

Interventions

Randomization of patients between botulin toxin injections and 2-ductligation of the submandibular glands.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 6 years; 2. Cerebral palsy or other non-progressive neurological disorder; 3. Severe drooling (TDS > 3); 4. Maximal conservative treatment not enough effect; 5. Informed consent; 6. Motivated for follow-up.

Exclusion criteria

Exclusion criteria: 1. Former surgery or anatomical variation which makes the procedure impossible; 2. Treatment for drooling at same time; 3. Use of Benzodiazepines.

Design outcomes

Primary

Measure	Time frame
>50% reduction in the DQ or caregivers Visual Analogue Scale	—

Secondary

Measure	Time frame
1. Impact on life; 2. Complications; 3. Duration of surgery.	—

Contacts

Public ContactSaskia Kok

Universitair Medisch Centrum St Radboud Afdeling Keel- Neus- en Oorheelkunde (377) Postbus 9101

s.kok@kno.umcn.nl+31 (0)24 36 14933

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)