Efficacy of Prednisolone for Bell Palsy in Children

Abstract

Background and Objective:Corticosteroids are used to treat the early stages of idiopathic facial paralysis (Bell’s palsy) in children, but their effectiveness is uncertain. We set out to determine if prednisolone improves the proportion of children with Bell’s palsy with complete recovery at one month.Methods:We conducted a double-blind, placebo-controlled, randomised trial of prednisolone in children presenting to emergency departments with Bell’s palsy. Patients aged 6 months to less than 18 years, recruited within 72 hours after symptom onset, were randomly assigned to receive 10 days of treatment with oral prednisolone (approximately 1 mg/kg) or placebo. The primary outcome was complete recovery of facial function at 1 month rated on the House–Brackmann scale. Secondary outcomes included facial function, adverse events and pain up to 6 months. Target recruitment was n=540 (270 per group).Results:Between 13 October 2015 to 23 August 2020, 187 children were randomised (94 to prednisolone and 93 to placebo) and included in the intention-to-treat analysis. At 1 month, the proportions of patients who had recovered facial function were 49% (n=43/87) in the prednisolone group compared with 57% (n=50/87) in the placebo group (risk difference -8.1%, 95% CI -22.8 to 6.7; adjusted odds ratio [aOR] 0.7, 95% CI 0.4 to 1.3). At 3 months these proportion were 90% (n=71/79) for the prednisolone group versus 85% (n=72/85) for the placebo group (risk difference 5.2%, 95%, CI -5.0 to 15.3; aOR 1.2, 95% CI 0.4 to 3.0) and at 6 months 99% (n=77/78) and 93% (n=76/82) respectively (risk difference 6.0%, 95% CI -0.1 to 12.2; aOR 3.0 95% CI 0.5 to 17.7) There were no serious adverse events and little evidence for group differences in secondary outcomes.Discussion:In children with Bell’s palsy the vast majority recover without treatment. The study, although underpowered, does not provide evidence that early treatment with prednisolone improves complete recovery.Registration:Registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561, registered 1 June 2015, ://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368505&isReview=trueClassification of evidence:This study provides Class I evidence that for children with Bell's palsy, prednisolone does not significantly change recovery of complete facial function at one month. However, the study lacked the precision to exclude an important harm or benefit from prednisolone.

Agreement of Clinician‐Administered and Modified Parent‐Administered House‐Brackmann Scales in Children with Bell's Palsy

“…Data on facial function scales from clinicians and parents for the current study come from our phase III, triple‐blinded, randomized, placebo‐controlled trial of prednisolone for the treatment of Bell's palsy in children. 4 , 16 This study was conducted in 11 emergency departments (EDs) in the Paediatric Research in Emergency Departments International Collaborative (PREDICT) research network in Australia and New Zealand between October 13, 2015, and August 23, 2020. The study protocol has been published with relevant details extracted below.…”

“…Acute facial nerve palsy (FNP) is a relatively common condition in children, 1 , 2 with most cases idiopathic and referred to as Bell's palsy. 3 , 4 FNP has functional, cosmetic, and psychosocial implications for affected children. 5 , 6 , 7 The degree of facial impairment is monitored by clinicians to identify those at risk of prolonged or permanent facial weakness.…”

“… 11 , 12 , 13 As part of a body of work to improve care for children with FNP, we have developed a modified version of the House‐Brackmann scale for parents (parent House‐Brackmann scale), which removed or exchanged medical terms that were not intuitively understandable (Figure 2 ). 2 , 4 , 14 , 15 , 16 , 17 We recently completed a placebo‐controlled randomized trial in children with Bell's palsy, indicating that prednisolone is not associated with improved recovery of complete facial function at 1 month. 4 The primary outcome in this study, complete recovery at 1 month, was measured using the clinician‐administered House‐Brackmann scale, as was severity of the FNP at baseline and at 1, 3, and 6 months.…”

“… 2 , 4 , 14 , 15 , 16 , 17 We recently completed a placebo‐controlled randomized trial in children with Bell's palsy, indicating that prednisolone is not associated with improved recovery of complete facial function at 1 month. 4 The primary outcome in this study, complete recovery at 1 month, was measured using the clinician‐administered House‐Brackmann scale, as was severity of the FNP at baseline and at 1, 3, and 6 months. At each time point, parents were given the modified parent House‐Brackmann scale to administer themselves.…”

Incomplete Enrollment in Clinical Trials

“…In this issue of Neurology ®, the authors 4 report a phase-3, double-blind, randomized, placebo-controlled superiority trial of oral prednisolone treatment for children with facial palsy enrolled across 11 emergency departments in the Pediatric Research in Emergency Departments International Collaborative research network in Australia and New Zealand. The primary outcome was the House-Brackmann scale score, which assesses facial function, at 1 month.…”