Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisolone, Placebo Oral Tablet.
- Who it may be relevant to
- Registry conditions: Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System, Bell Palsy. Basic parameters: 1 year — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial
Overview
Acute facial nerve palsy occur in 10-20/100 000 children/year in Sweden. About 20 % of these children will have persistent symptoms with excessive tear secretion, drooling and social problems due to asymmetry in the face. Studies on cortisone treatment to adult patients with acute facial nerve palsy have shown beneficial effects, but no studies with strong quality have been performed in children. Investigators will perform a double-blind randomized placebo-controlled multicenter trial on children with acute facial nerve palsy. Participants will be recruited consecutively at 9-12 study centers in Sweden during 2019-2020. Oral cortisone (prednisolone) 1 mg/kg x 1 in 10 days (or placebo) will be started on admission. Clinical data, including recovery will be followed-up until 12 months. The primary outcome is defined as total recovery of the facial nerve palsy, measured with the House-Brackmann scale (grade 1) at 12-months follow-up. The overall purpose is to assess the utility of cortisone treatment given to children with acute facial nerve palsy in this study. If the total recovery rate is significantly improved in the prednisolone group as compared to the placebo group, prednisolone treatment will be introduced in clinical practice for children with acute facial nerve palsy in order to reduce the risk of persistent symptoms.
Interventions
- Drug Prednisolone
Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day. - Drug Placebo Oral Tablet
Placebo tablets with identical appearance to the experimental drug
Primary outcome measures
- House-Brackmann scale [Time frame: At 12 months (+/- 2 weeks) after inclusion]
Secondary outcome measures (4)
- Sunnybrook facial grading system [Time frame: At 12 months (+/- 2 weeks) after inclusion]
- Facial Disability Index (FDI) [Time frame: At 12 months (+/- 2 weeks) after inclusion]
- Facial Clinimetric Evaluation (FaCE) Scale [Time frame: At 12 months (+/- 2 weeks) after inclusion]
- Synkinesis Assessment Questionnaire (SAQ) [Time frame: At 12 month (+/- 2 weeks) after inclusion]
Eligibility criteria
Inclusion criteria
- 1-17 years of age
- Acute peripheral unilateral facial nerve palsy
- Less than 72 hours since debut of symptoms
- Signed informed consent
Exclusion criteria
- Head trauma <1 month
- Central or bilateral facial nerve palsy
- Malformations in head and neck
- Conditions not compatible with cortisone treatment (arterial hypertension, diabetes mellitus, psychiatric disorder, active or latent tuberculosis, intolerance of lactose)
- Current or past oncological diagnosis
- Other serious medical conditions (meningitis, encephalitis, stroke)
- Acute otitis media
- Signs of herpes simplex or varicella zoster infection (vesicles in the ear region)
- Pregnancy or breastfeeding
- Use of any systemic or inhaled steroids within 2 weeks prior onset of symptoms
- Immunization with live vaccine 1 month prior onset of symptoms
- Requirement of live vaccine within 2 months from start of experimental treatment (prednisolone or placebo)
- Evaluation of primary endpoint at 12 months not feasible for any reason
- Previously included into the FACE study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Sweden · 15 centers
- Barn- och ungdomsmedicin — Falun
- Barn och ungdomskliniken, Länssjukhuset — Kalmar
- Barnkliniken, Skaraborgs sjukhus — Skövde
- Barnmedicin Drottning Silvias Barn- och Ungdomssjukhus Östra Sjukhuset — Gothenburg
- Barn- och ungdomsmedicinska kliniken — Jönköping
- Barn- och ungdomsmottagning — Karlskrona
- HKH Kronprinsessan Viktorias Barn- och ungdomssjukhus — Linköping
- Akutmottagning för barn, Skåne Universitets sjukhus — Lund
- … and 7 more centers
Publications
- Karlsson S, Arnason S, Hadziosmanovic N, Laestadius A, Hultcrantz M, Marsk E, Skogman BH. The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area. BMC Pediatr. 2021 May 4;21(1):220. doi: 10.1186/s12887-021-02571-w. PMID 33947355
Identifiers
NCT: NCT03781700 · FACE-01 · 2017-004187-35