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Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter
Franz E Babl1, David Herd2, Meredith L Borland2
1From the Emergency Department (F.E.B., E.O., S.M.H., J.A.C., A. Williams, H.E.), Royal Children's Hospital; Clinical Sciences (F.E.B., E.O., A.D., S.M.H., J.A.C., R.G.B., S.H., C.L.W., A. Williams, H.E., M.T.M.), Murdoch Children's Research Institute, Parkville; Departments of Paediatrics (F.E.B., E.O., A.D., S.M.H., R.G.B., M.T.M., K.J.L.) and Critical Care (F.E.B., E.O., S.H.), Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria; Emergency Department (D.H.), Queensland Children's Hospital; University of Queensland (D.H.); Mater Research Institute (D.H.), Brisbane, Queensland; Emergency Department (M.L.B.), Perth Children's Hospital; Divisions of Emergency Medicine and Paediatrics (M.L.B.), University of Western Australia, Perth; Emergency Department (A.K.), Women's and Children's Hospital, Adelaide; Emergency Department (B.L.), Logan Hospital, Brisbane, Queensland; Emergency Department (J.H.), The Children's Hospital at Westmead, Sydney; Emergency Department (A. West, J.A.C.), Monash Medical Centre, Clayton, Victoria; Department of Emergency Medicine (S.G.), Gold Coast University Hospital, Southport; School of Medicine and Menzies Health Institute Queensland (S.G.), Griffith University, Southport; Child Health Research Centre (S.G.), The University of Queensland, South Brisbane; Emergency Department (M.Z.), John Hunter Hospital, Newcastle, New South Wales; Emergency Department (K.V.), Townsville Hospital; James Cook University College of Medicine and Dentistry (K.V.), Townsville, Australia; University of St Andrews (F.S.), School of Medicine, Edinburgh, United Kingdom; North York General Hospital (F.S.), Department of Family & Community Medicine and Dalla Lana School of Public Health, University of Toronto, Ontario, Canada; Department of Anaesthesia (A.D.), Royal Children's Hospital; Department of Otolaryngology (R.G.B.), Pharmacy Department (D.L.), and Department of Neurology (M.T.M.), Royal Children's Hospital; Clinical Epidemiology and Biostatistics Unit (K.J.L.) and Melbourne Children's Trial Centre (A.D., K.J.L.), Murdoch Children's Research Institute, Parkville, Victoria, Australia; Children's Emergency Department (S.R.D.), Starship Children's Hospital, Auckland; and Departments of Surgery and Paediatrics: Child and Youth Health (S.R.D.), University of Auckland, New Zealand. franz.babl@rch.org.au.
Background And Objectives:
Corticosteroids are used to treat the early stages of idiopathic facial paralysis (Bell palsy) in children, but their effectiveness is uncertain. We set out to determine whether prednisolone improves the proportion of children with Bell palsy with complete recovery at 1 month.
Methods:
We conducted a double-blind, placebo-controlled, randomized trial of prednisolone in children presenting to emergency departments with Bell palsy. Patients aged 6 months to younger than 18 years were recruited within 72 hours after the symptom onset and 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 October 13, 2015, and August 23, 2020, 187 children were randomized (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 proportions were 90% (n = 71/79) for the prednisolone group vs 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 palsy, the vast majority recover without treatment. This study, although underpowered, does not provide evidence that early treatment with prednisolone improves complete recovery.
Trial Registration Information:
Registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561, registered June 1, 2015. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368505&isReview=true.
Classification Of Evidence:
This study provides Class I evidence that for children with Bell palsy, prednisolone does not significantly change recovery of complete facial function at 1 month. However, this study lacked the precision to exclude an important harm or benefit from prednisolone.
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