Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy (FACE)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    500
  • sponsor
    Dalarna County Council, Sweden
Updated on 9 February 2022

Summary

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.

Details
Condition Facial Palsy, Facial Nerve Diseases, Borrelia Infection of Central Nervous System, Bell Palsy
Treatment Prednisolone, Placebo Oral Tablet
Clinical Study IdentifierNCT03781700
SponsorDalarna County Council, Sweden
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

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
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