TY - JOUR
T1 - Efficacy of prednisolone for Bell palsy in children
T2 - a randomized, double-blind, placebo-controlled, multicenter trial
AU - Babl, Franz E
AU - Herd, David
AU - Borland, Meredith
AU - Kochar, Amit
AU - Lawton, Ben
AU - Hort, Jason
AU - West, Adam
AU - George, Shane
AU - Zhang, Michael
AU - Velusamy, Karthik
AU - Sullivan, Frank
AU - Oakley, Ed
AU - Davidson, Andrew
AU - Hopper, Sandy M
AU - Cheek, John A
AU - Berkowitz, Robert
AU - Hearps, Stephen
AU - Wilson, Catherine L
AU - Williams, Amanda
AU - Elborough, Hannah
AU - Legg, Donna
AU - Pharm, B
AU - Mackay, Mark T
AU - Lee, Katherine J
AU - Dalziel, Stuart R
AU - Paediatric Research in Emergency Departments International Collaborative (PREDICT)
N1 - Funding: The study was funded by a grant from the National Health and Medical Research Council (NHMRC, project grant GNT1078069), Canberra, Australia, the Emergency Medicine Foundation (EMSS-312R26-2016-GEORGE), Brisbane, Australia and the Perth Children’s Hospital Foundation project grant #9670, Perth, Australia. The PREDICT research network was part funded by an NHMRC Center of Research Excellence grant (GNT1058560), Canberra, Australia, the Murdoch Children’s Research Institute, Melbourne, Australia, and the Victorian Government’s Operational Infrastructure Support program. FEB’s time was part funded by a grant from the Royal Children’s Hospital Foundation, Melbourne, Victoria, Australia and an NHMRC Practitioner Fellowship. SRD’s time was part funded by the Health Research Council of New Zealand (HRC13/556) and Cure Kids, Auckland, New Zealand.
PY - 2022/11/15
Y1 - 2022/11/15
N2 - Background and ObjectiveCorticosteroids 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.MethodsWe 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).ResultsBetween 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.DiscussionIn 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.
AB - Background and ObjectiveCorticosteroids 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.MethodsWe 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).ResultsBetween 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.DiscussionIn 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.
U2 - 10.1212/WNL.0000000000201164
DO - 10.1212/WNL.0000000000201164
M3 - Article
C2 - 36008143
SN - 0028-3878
VL - 99
SP - 2241
EP - 2252
JO - Neurology
JF - Neurology
IS - 20
M1 - 201164
ER -