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

BMC Pediatrics

Study Protocol

Amanda Williams¹  Sandy Hopper²  Ed Oakley²  Franz E. Babl²  John A. Cheek³  Frank Sullivan⁴  Kim Marie Dalziel⁵  Robert Berkowitz⁶  Shane George⁷  Michael Zhang⁸  David W. Herd⁹  Catherine Wilson^1,10  Fiona Williams^1,10  Kaya Gardiner^1,10  Katherine J. Lee^1,11  Andrew Davidson^1,12  Mark T. Mackay^1,13  Vicki Anderson^1,14  Emily Porrello^1,15  Meredith L. Borland^1,16  Stuart R Dalziel^1,17  Lisa Barrow^1,18  Arjun Rao^1,19  Jason Hort^2,20  Jeremy Furyk^2,21  Amit Kochar^2,22 

[1] Department of Emergency Medicine, Royal Children’s Hospital, Flemington Rd, 3052, Parkville, VIC, Australia;Murdoch Children’s Research Institute, Parkville, Victoria, Australia;Department of Emergency Medicine, Royal Children’s Hospital, Flemington Rd, 3052, Parkville, VIC, 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;Department of Emergency Medicine, Royal Children’s Hospital, Flemington Rd, 3052, Parkville, VIC, Australia;Murdoch Children’s Research Institute, Parkville, Victoria, Australia;Monash Medical Centre, Clayton, Victoria, Australia;Department of Family & Community Medicine, North York General Hospital, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada;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;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;Gold Coast University Hospital, Southport, Queensland, Australia;John Hunter Hospital, Newcastle, New South Wales, Australia;Lady Cilento Children’s Hospital, Brisbane, Australia;University of Queensland, Brisbane, Australia;Mater Research Institute, Brisbane, Australia;Murdoch Children’s Research Institute, Parkville, Victoria, 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;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;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;Murdoch Children’s Research Institute, Parkville, Victoria, Australia;Psychological Sciences & Paediatrics, University of Melbourne, The Royal Children’s Hospital, Melbourne, VIC, Australia;Pharmacy Department, Royal Children’s Hospital, Parkville, Victoria, Australia;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;Starship Hospital, Auckland, New Zealand;Liggins Institute, University of Auckland, Auckland, New Zealand;Sunshine Hospital, St Albans, Victoria, Australia;Sydney Children’s Hospital, Randwick, New South Wales, Australia;The Children’s Hospital at Westmead, Sydney, Australia;Townsville Hospital and James Cook University College of Medicine and Dentistry, Townsville, Australia;Women’s & Children’s Hospital, Adelaide, Australia;

关键词: Bell’s palsy;    Facial nerve palsy;    Prednisolone;    Randomised controlled trial;    Child;    House Brackmann scale;   

DOI  :  10.1186/s12887-016-0702-y

 received in 2016-03-13, accepted in 2016-09-27,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundBell’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.Methods/DesignWe 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.DiscussionThis 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.Trial registrationThe study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015).

【 授权许可】

CC BY   
© The Author(s). 2016