Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy
Status:
Recruiting
Trial end date:
2026-12-31
Target enrollment:
Participant gender:
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.