Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial

Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete r...

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Bibliographic Details
Published in:BMC pediatrics 2017-02, Vol.17 (1), p.53, Article 53
Main Authors: Babl, Franz E, Mackay, Mark T, Borland, Meredith L, Herd, David W, Kochar, Amit, Hort, Jason, Rao, Arjun, Cheek, John A, Furyk, Jeremy, Barrow, Lisa, George, Shane, Zhang, Michael, Gardiner, Kaya, Lee, Katherine J, Davidson, Andrew, Berkowitz, Robert, Sullivan, Frank, Porrello, Emily, Dalziel, Kim Marie, Anderson, Vicki, Oakley, Ed, Hopper, Sandy, Williams, Fiona, Wilson, Catherine, Williams, Amanda, Dalziel, Stuart R
Format: Article
Language:English
Subjects:
Adolescent
Bell Palsy - drug therapy
Bell Palsy - epidemiology
Bell Palsy - physiopathology
Bell's palsy
Child
Child, Preschool
Clinical medicine
Dose-Response Relationship, Drug
Emergency medical care
Female
Follow-Up Studies
Glucocorticoids - administration & dosage
Humans
Incidence
Infant
Male
New Zealand - epidemiology
Otolaryngology
Pathophysiology
Prednisolone - administration & dosage
Quality of Life
Recovery of Function
Steroids
Study Protocol
Time Factors
Treatment Outcome
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Summary:Bell's palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell's palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell's palsy in children in a randomised placebo-controlled trial. We are conducting a randomised, triple-blinded, placebo controlled trial of the use of prednisolone to improve recovery from Bell's palsy at 1 month. Study sites are 10 hospitals within the Australian and New Zealand PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. 540 participants will be enrolled. To be eligible patients need to be aged 6 months to 
ISSN:1471-2431
1471-2431
DOI:10.1186/s12887-016-0702-y