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

Abstract

Background Children with acute peripheral facial nerve palsy cannot yet be recommended corticosteroid treatment based on evidence. Adults with idiopathic facial nerve palsy are treated with corticosteroids, according to guidelines resulting from a meta-analysis comprising two major randomized placebo-controlled trials. Corresponding trials in children are lacking. Furthermore, acute facial nerve palsy in childhood is frequently associated with Lyme neuroborreliosis, caused by the spirochete Borrelia burgdorferi. The efficacy and safety of corticosteroid treatment of acute facial nerve palsy associated with Lyme neuroborreliosis, has not yet been determined in prospective trials in children, nor in adults. Method This randomized double-blind, placebo-controlled study will include a total of 500 Swedish children aged 1–17 years, presenting with acute facial nerve palsy of either idiopathic etiology or associated with Lyme neuroborreliosis. Inclusion is ongoing at 12 pediatric departments, all situated in Borrelia burgdorferi endemic areas. Participants are randomized into active treatment with prednisolone 1 mg/kg/day (maximum 50 mg/day) or placebo for oral intake once daily during 10 days without taper. Cases associated with Lyme neuroborreliosis are treated with antibiotics in addition to the study treatment. The House-Brackmann grading scale and the Sunnybrook facial grading system are used for physician-assessed evaluation of facial impairment at baseline, and at the 1- and 12-month follow-ups. Primary outcome is complete recovery, measured by House-Brackmann grading scale, at the 12-month follow-up. Child/parent-assessed questionnaires are used for evaluation of disease-specific quality of life and facial disability and its correlation to physician-assessed facial impairment will be evaluated. Furthermore, the study will evaluate factors of importance for predicting recovery, as well as the safety profile for short-term prednisolone treatment in children with acute facial nerve palsy. Discussion This article presents the rationale, design and content of a protocol for a study that will determine the efficacy of corticosteroid treatment in children with acute facial nerve palsy of idiopathic etiology, or associated with Lyme neuroborreliosis. Future results will attribute to evidence-based treatment guidelines applicable also in Borrelia burgdorferi endemic areas. Trial registration The study protocol was approved by the Swedish Medical Product Agency (EudraCT nr 2017–004187-35) and published at ClinicalTrials.gov (NCT03781700, initial release 12/14/2018).

Acute otitis media-related facial nerve palsy in a child: a case report and a literary review

“…As far the use of corticosteroid treatment for facial nerve palsy, despite a few studies are available, it seems that steroids may reduce the time of recovery, especially when administered early in the disease course [ 7 , 9 ]. To better understand the role of corticosteroids in the treatment of children with idiopathic facial nerve palsy, two randomized, double-blind, placebo-controlled trials have recently been started [ 23 , 24 ].…”

Efficacy and safety of pharmacological treatments for Lyme neuroborreliosis: An updated systematic review

“…Drawing conclusions from these studies for clinical practice is therefore limited. New evidence on this issue can be expected from a planned RCT from Sweden evaluating steroids in children with facial palsy related to LNB [27].…”

Efficacy of Prednisolone for Bell Palsy in Children

“…Lyme disease, which does not exist in Australasia, can cause facial paralysis and may be an important consideration in early diagnostic and management decisions in patients considered for a treatment in Lyme endemic areas. 26,30…”

“…Lyme disease, which does not exist in Australasia, can cause facial paralysis and may be an important consideration in early diagnostic and management decisions in patients considered for a treatment in Lyme endemic areas. 26,30 Despite our insufficient sample size, the 95% CIs around the effect size for the primary outcome of complete recovery from Bell palsy at 1 month ranged from 22% in favor of placebo to only 6% in favor of prednisolone. There were also high spontaneous recovery by 6 months, low rates of morbidity from pain or synkinesis, clinical concern regarding prescribing of prednisolone in children with Bell palsy that may represent the first presentation of an oncological diagnosis, and concern regarding the use of prednisolone in Lyme disease.…”