drooling sialorrhea
Conditions
Interventions
Participants in the study undergo either injection with botulinum toxin or
2-duct ligation. Both procedures are performed in daycare surgery.
A) 2-duct ligation
The patient is put under general ane
Allergan, Nieuwegein,
Netherlands), reconstituted with 0.9% sodium chloride solution, is injected
bilaterally in the submandibular glands using a 25-G needle and a 1-mL syringe.
On injection, each
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 6 years or above - Cerebral palsy or other non-progressive neurological disease - Severe drooling (Drooling Frequency >=3; Drooling Severity >=2) - Conservative treatment has not led to adequate reduction of droolng - Informed consent - Cognitive ability of parents is adequate to participate in the study, as judged by the researchers. - Participants are motived to return for follow up after 2, 8 and 32 weeks.
Exclusion criteria
Exclusion criteria: - Concurrent participation in other medical study - Previous surgery or anatomical abnormalities that prohibit either application of botulinum toxin or surgery - Concurrent other treatment for drooling - Use of benzodiazepines - Allergy to botulinum toxin or other contraindication for botulinumtoxin or surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the extent of drooling. This is mainly assessed using the drooling quotient and a VAS-score. Both methods have been used significantly. The drooling quotient is a validated tool to semi-objectively quantify the extent of drooling. During two ten-minute sessions, the absence or presence of new saliva on the lip is recorded every fifteen seconds. The first session is performed while resting, the second while a child is distracted. The drooling quotient is obtained by dividing the number of observed drooling episodes by 0.4. The resulting quotient reflects the relative time a person drools. The VAS is recorded by parents or caretakes, to investigate therapy results as experienced in the home situation. Scales of exactly 10 cm without visible subdivisions are presented, on which the average degree of drooling severity during the 10 to 14 days before assessment is to be indicated. A mark at the left end represents severe drooling; a mark at the right end means no drooling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the extent of drooling, quality of life, complications, admission time and duration of the procedure. | — |
Countries
Netherlands
Outcome results
None listed