The Facial Nerve Palsy And Cortisone Evaluation (FACE) Study in Children: A Randomized Double-blind, Placebo-controlled, Multicenter Trial

What this Trial Is About

Researchers are evaluating the use of oral cortisone (prednisolone) treatment in children aged 1 to 17 years who have acute peripheral unilateral facial nerve palsy. This condition affects about 10 to 20 children per 100,000 annually in Sweden, with 20% experiencing lasting symptoms such as excessive tearing, drooling, and facial asymmetry. The study is a double-blind, randomized, placebo-controlled multicenter trial aimed at assessing whether prednisolone improves recovery compared to placebo over 12 months. Participants will be randomly assigned to receive either prednisolone tablets dosed at 1 mg per kg of body weight daily for 10 days (up to a maximum of 50 mg per day) or placebo tablets that look identical. The treatment will start upon admission, and clinical data will be collected during follow-up visits. The primary outcome is full recovery of facial nerve function measured by the House-Brackmann scale at 12 months, with additional facial function and disability assessments also conducted. During the study, children will undergo clinical evaluations at regular intervals up to 12 months to monitor nerve recovery and facial function using several scales and questionnaires. Researchers will track adherence to treatment and monitor for any side effects or complications. The total participation time for each child will be approximately one year, allowing detailed observation of long-term outcomes and treatment effects.

Evaluation of Cortisone Treatment in Children With Acute Facial Nerve Palsy