Drooling or sialorrhea
Conditions
Interventions
Trade Name: Ethanol
Product Name: Ethanol 96%
Product Code: EP00159
Pharmaceutical Form: Concentrate and solvent for intravesical solution
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Moderate to severe drooling indicated by Drooling Frequency Score = 3 or Drooling Severity Score = 2. 2. Aged 10 years and older. 3. Cerebral palsy or any other non-progressive neurodevelopmental disability. 4. Contra-indications for a SMDR, or rejection towards a SMDR by patient or caregiv-ers* 5. Ability and willingness to follow the study protocol and attend the 8 and 32-weeks vis-its. 6. Written and informed consent from caregivers, and when appropriate, oral consent from the child. * contra-indication for SMDR: - posterior drooling - pharyngeal dysphagia as judged by the speech and language therapist. - progressive neurodisability as judged by the child neurologist. Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Medical history of salivary gland abnormalities like ductal stenosis, strictures 2. Previous submandibular salivary gland surgery, or other contraindications for surgery or general anesthesia. 3. Recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection 4. Simultaneous alternative treatment for drooling.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility of submandibular duct ligation right after intraductal ethanol infusion into the submandibular salivary gland;Secondary Objective: The secondary aims of the study are to evaluate effect, and to evaluate whether an out-patient setting is suitable for the procedure. ;Primary end point(s): a. Adverse events. b. Post-operative complaints c. Surgical time. ;Timepoint(s) of evaluation of this end point: baseline, 8 and 32 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: baseline, 8 and 32 weeks;Secondary end point(s): All parameters will be compared to the previous results of 2-DL without infusion of ethanol in this institution. Secondary study parameters. The following five variables will be collected as standard care although these are not among the outcomes of the current study. 1. Visual Analog Scale for the severity of drooling 2. Drooling Quotient 3. Treatment effect 4. Drooling Severity Scale 5. Drooling Frequency Scale 6. Costs | — |
Countries
Netherlands
Contacts
Public ContactContact person
Radboudumc
Outcome results
None listed