title: Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.
abstract: 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 < 18 years and present within 72 hours of onset of clinician diagnosed Bell's palsy to one of the participating hospital emergency departments. Patients will be excluded in case of current use of or contraindications to steroids or if there is an alternative diagnosis. Participants will receive either prednisolone 1 mg/kg/day to a maximum of 50 mg/day or taste matched placebo for 10 days. The primary outcome is complete recovery by House-Brackmann scale at 1 month. Secondary outcomes include assessment of recovery using the Sunnybrook scale, the emotional and functional wellbeing of the participants using the Pediatric Quality of Life Inventory and Child Health Utility 9D Scale, pain using Faces Pain Scale Revised or visual analogue scales, synkinesis using a synkinesis assessment questionnaire and health utilisation costs at 1, 3 and 6 months. Participants will be tracked to 12 months if not recovered earlier. Data analysis will be by intention to treat with primary outcome presented as differences in proportions and an odds ratio adjusted for site and age.
  
  
  
  This large multicenter randomised trial will allow the definitive assessment of the efficacy of prednisolone compared with placebo in the treatment of Bell's palsy in children.
  
  
  
  The study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015).
authors.affiliation: Department of Emergency Medicine, Royal Children's Hospital, Flemington Rd, Parkville, VIC, 3052, Australia. franz.babl@rch.org.au.|Murdoch Children's Research Institute, Parkville, Victoria, Australia. franz.babl@rch.org.au.|Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia. franz.babl@rch.org.au.
authors.forename: Franz E
authors.initials: FE
authors.lastname: Babl
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.|Department of Neurology, Royal Children's Hospital, Parkville, VIC, Australia.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Mackay
authors.affiliation: Princess Margaret Hospital for Children, Perth, Australia.|Schools of Paediatric and Child Health and Primary, Aboriginal and Rural Health Care, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Meredith L
authors.initials: ML
authors.lastname: Borland
authors.affiliation: Lady Cilento Children's Hospital, Brisbane, Australia.|University of Queensland, Brisbane, Australia.|Mater Research Institute, Brisbane, Australia.
authors.forename: David W
authors.initials: DW
authors.lastname: Herd
authors.affiliation: Women's & Children's Hospital, Adelaide, Australia.
authors.forename: Amit
authors.initials: A
authors.lastname: Kochar
authors.affiliation: The Children's Hospital at Westmead, Sydney, Australia.
authors.forename: Jason
authors.initials: J
authors.lastname: Hort
authors.affiliation: Sydney Children's Hospital, Randwick, New South Wales, Australia.
authors.forename: Arjun
authors.initials: A
authors.lastname: Rao
authors.affiliation: Department of Emergency Medicine, Royal Children's Hospital, Flemington Rd, Parkville, VIC, 3052, Australia.|Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Monash Medical Centre, Clayton, Victoria, Australia.
authors.forename: John A
authors.initials: JA
authors.lastname: Cheek
authors.affiliation: Townsville Hospital and James Cook University College of Medicine and Dentistry, Townsville, Australia.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Furyk
authors.affiliation: Sunshine Hospital, St Albans, Victoria, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Barrow
authors.affiliation: Gold Coast University Hospital, Southport, Queensland, Australia.
authors.forename: Shane
authors.initials: S
authors.lastname: George
authors.affiliation: John Hunter Hospital, Newcastle, New South Wales, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Zhang
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.
authors.forename: Kaya
authors.initials: K
authors.lastname: Gardiner
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
authors.forename: Katherine J
authors.initials: KJ
authors.lastname: Lee
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.|Department of Anaesthesia, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Davidson
authors.affiliation: Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.|Department of Otolaryngology, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Berkowitz
authors.affiliation: Department of Family & Community Medicine, North York General Hospital, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
authors.forename: Frank
authors.initials: F
authors.lastname: Sullivan
authors.affiliation: Pharmacy Department, Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Emily
authors.initials: E
authors.lastname: Porrello
authors.affiliation: Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.|Centre for Health Policy Melbourne School of Global and Population Health, The University of Melbourne, Carlton, Victoria, Australia.
authors.forename: Kim Marie
authors.initials: KM
authors.lastname: Dalziel
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Psychological Sciences & Paediatrics, University of Melbourne, The Royal Children's Hospital, Melbourne, VIC, Australia.
authors.forename: Vicki
authors.initials: V
authors.lastname: Anderson
authors.affiliation: Department of Emergency Medicine, Royal Children's Hospital, Flemington Rd, Parkville, VIC, 3052, Australia.|Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
authors.forename: Ed
authors.initials: E
authors.lastname: Oakley
authors.affiliation: Department of Emergency Medicine, Royal Children's Hospital, Flemington Rd, Parkville, VIC, 3052, Australia.|Murdoch Children's Research Institute, Parkville, Victoria, Australia.|Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
authors.forename: Sandy
authors.initials: S
authors.lastname: Hopper
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.
authors.forename: Fiona
authors.initials: F
authors.lastname: Williams
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia.
authors.forename: Catherine
authors.initials: C
authors.lastname: Wilson
authors.affiliation: Department of Emergency Medicine, Royal Children's Hospital, Flemington Rd, Parkville, VIC, 3052, Australia.|Murdoch Children's Research Institute, Parkville, Victoria, Australia.
authors.forename: Amanda
authors.initials: A
authors.lastname: Williams
authors.affiliation: Starship Hospital, Auckland, New Zealand.|Liggins Institute, University of Auckland, Auckland, New Zealand.
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Dalziel
mesh_terms: D000293:Adolescent; D020330:Bell Palsy / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D011239:Prednisolone / Q000008:administration & dosage*; D011788:Quality of Life; D020127:Recovery of Function; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone
keywords: Bell’s palsy; Child; Facial nerve palsy; House Brackmann scale; Prednisolone; Randomised controlled trial