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Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.
BMC Pediatr. 2017 02 13; 17(1):53.BPed

Abstract

BACKGROUND

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.

METHODS/DESIGN

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.

DISCUSSION

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.

TRIAL REGISTRATION

The study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015).

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Authors+Show Affiliations

Babl FE
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.
Mackay MT
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.
Borland ML
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.
Herd DW
Lady Cilento Children's Hospital, Brisbane, Australia. University of Queensland, Brisbane, Australia. Mater Research Institute, Brisbane, Australia.
Kochar A
Women's & Children's Hospital, Adelaide, Australia.
Hort J
The Children's Hospital at Westmead, Sydney, Australia.
Rao A
Sydney Children's Hospital, Randwick, New South Wales, Australia.
Cheek JA
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.
Furyk J
Townsville Hospital and James Cook University College of Medicine and Dentistry, Townsville, Australia.
Barrow L
Sunshine Hospital, St Albans, Victoria, Australia.
George S
Gold Coast University Hospital, Southport, Queensland, Australia.
Zhang M
John Hunter Hospital, Newcastle, New South Wales, Australia.
Gardiner K
Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Lee KJ
Murdoch Children's Research Institute, Parkville, Victoria, Australia. Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia.
Davidson A
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.
Berkowitz R
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.
Sullivan F
Department of Family & Community Medicine, North York General Hospital, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.
Porrello E
Pharmacy Department, Royal Children's Hospital, Parkville, Victoria, Australia.
Dalziel KM
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.
Anderson V
Murdoch Children's Research Institute, Parkville, Victoria, Australia. Psychological Sciences & Paediatrics, University of Melbourne, The Royal Children's Hospital, Melbourne, VIC, Australia.
Oakley E
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.
Hopper S
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.
Williams F
Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Wilson C
Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Williams A
Department of Emergency Medicine, Royal Children's Hospital, Flemington Rd, Parkville, VIC, 3052, Australia. Murdoch Children's Research Institute, Parkville, Victoria, Australia.
Dalziel SR
Starship Hospital, Auckland, New Zealand. Liggins Institute, University of Auckland, Auckland, New Zealand.
PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network
No affiliation info available

MeSH

AdolescentBell PalsyChildChild, PreschoolDose-Response Relationship, DrugFemaleFollow-Up StudiesGlucocorticoidsHumansIncidenceInfantMaleNew ZealandPrednisoloneQuality of LifeRecovery of FunctionTime FactorsTreatment Outcome

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28193257

Citation

Babl, Franz E., et al. "Bell's Palsy in Children (BellPIC): Protocol for a Multicentre, Placebo-controlled Randomized Trial." BMC Pediatrics, vol. 17, no. 1, 2017, p. 53.
Babl FE, Mackay MT, Borland ML, et al. Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial. BMC Pediatr. 2017;17(1):53.
Babl, F. E., Mackay, M. T., Borland, M. L., Herd, D. W., Kochar, A., Hort, J., Rao, A., Cheek, J. A., Furyk, J., Barrow, L., George, S., Zhang, M., Gardiner, K., Lee, K. J., Davidson, A., Berkowitz, R., Sullivan, F., Porrello, E., Dalziel, K. M., ... Dalziel, S. R. (2017). Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial. BMC Pediatrics, 17(1), 53. https://doi.org/10.1186/s12887-016-0702-y
Babl FE, et al. Bell's Palsy in Children (BellPIC): Protocol for a Multicentre, Placebo-controlled Randomized Trial. BMC Pediatr. 2017 02 13;17(1):53. PubMed PMID: 28193257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial. AU - Babl,Franz E, AU - Mackay,Mark T, AU - Borland,Meredith L, AU - Herd,David W, AU - Kochar,Amit, AU - Hort,Jason, AU - Rao,Arjun, AU - Cheek,John A, AU - Furyk,Jeremy, AU - Barrow,Lisa, AU - George,Shane, AU - Zhang,Michael, AU - Gardiner,Kaya, AU - Lee,Katherine J, AU - Davidson,Andrew, AU - Berkowitz,Robert, AU - Sullivan,Frank, AU - Porrello,Emily, AU - Dalziel,Kim Marie, AU - Anderson,Vicki, AU - Oakley,Ed, AU - Hopper,Sandy, AU - Williams,Fiona, AU - Wilson,Catherine, AU - Williams,Amanda, AU - Dalziel,Stuart R, AU - ,, Y1 - 2017/02/13/ PY - 2016/03/13/received PY - 2016/09/27/accepted PY - 2017/2/15/entrez PY - 2017/2/15/pubmed PY - 2018/1/27/medline KW - Bell’s palsy KW - Child KW - Facial nerve palsy KW - House Brackmann scale KW - Prednisolone KW - Randomised controlled trial SP - 53 EP - 53 JF - BMC pediatrics JO - BMC Pediatr VL - 17 IS - 1 N2 - BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: The study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015). SN - 1471-2431 UR - https://www.unboundmedicine.com/medline/citation/28193257/Bell's_Palsy_in_Children__BellPIC_:_protocol_for_a_multicentre_placebo_controlled_randomized_trial_ L2 - https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-016-0702-y DB - PRIME DP - Unbound Medicine ER -