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

Franz E. Babl; Mark T. Mackay; Meredith L. Borland; David W. Herd; Amit Kochar; Jason Hort; Arjun Rao; John A. Cheek; Jeremy Furyk; Lisa Barrow; Shane George; Michael Zhang; Kaya Gardiner; Katherine J. Lee; Andrew Davidson; Robert Berkowitz; Frank Sullivan; Emily Porrello; Kim Marie Dalziel; Vicki Anderson; Ed Oakley; Sandy Hopper; Fiona Williams; Catherine Wilson; Amanda Williams; Stuart R. Dalziel; PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network

doi:10.1186/s12887-016-0702-y

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

Franz E. Babl^*, Mark T. Mackay, Meredith L. Borland, David W. Herd, Amit Kochar, Jason Hort, Arjun Rao, John A. Cheek, Jeremy Furyk, Lisa Barrow, Shane George, Michael Zhang, Kaya Gardiner, Katherine J. Lee, Andrew Davidson, Robert Berkowitz, Frank Sullivan, Emily Porrello, Kim Marie Dalziel, Vicki AndersonEd Oakley, Sandy Hopper, Fiona Williams, Catherine Wilson, Amanda Williams, Stuart R. Dalziel, PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network

^*Corresponding author for this work

School of Medicine

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	53
Number of pages	11
Journal	BMC Pediatrics
Volume	17
Issue number	1
DOIs	https://doi.org/10.1186/s12887-016-0702-y
Publication status	Published - 13 Feb 2017

Keywords

Bell's palsy
Child
Facial nerve palsy
House Brackmann scale
Prednisolone
Randomised controlled trial

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© 2016 The Author(s). Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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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., ... PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network (2017). Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial. BMC Pediatrics, 17(1), Article 53. https://doi.org/10.1186/s12887-016-0702-y

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

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.",

keywords = "Bell's palsy, Child, Facial nerve palsy, House Brackmann scale, Prednisolone, Randomised controlled trial",

author = "Babl, {Franz E.} and Mackay, {Mark T.} and Borland, {Meredith L.} and Herd, {David W.} and Amit Kochar and Jason Hort and Arjun Rao and Cheek, {John A.} and Jeremy Furyk and Lisa Barrow and Shane George and Michael Zhang and Kaya Gardiner and Lee, {Katherine J.} and Andrew Davidson and Robert Berkowitz and Frank Sullivan and Emily Porrello and Dalziel, {Kim Marie} and Vicki Anderson and Ed Oakley and Sandy Hopper and Fiona Williams and Catherine Wilson and Amanda Williams and Dalziel, {Stuart R.} and {PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network}",

year = "2017",

month = feb,

day = "13",

doi = "10.1186/s12887-016-0702-y",

language = "English",

volume = "17",

journal = "BMC Pediatrics",

issn = "1471-2431",

publisher = "BioMed Central",

number = "1",

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Babl, FE, Mackay, MT, Borland, ML, Herd, DW, Kochar, A, Hort, J, Rao, A, Cheek, JA, Furyk, J, Barrow, L, George, S, Zhang, M, Gardiner, K, Lee, KJ, Davidson, A, Berkowitz, R, Sullivan, F, Porrello, E, Dalziel, KM, Anderson, V, Oakley, E, Hopper, S, Williams, F, Wilson, C, Williams, A, Dalziel, SR & PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network 2017, 'Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial', BMC Pediatrics, vol. 17, no. 1, 53. https://doi.org/10.1186/s12887-016-0702-y

TY - JOUR

T1 - Bell's Palsy in Children (BellPIC)

T2 - 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 - PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network

PY - 2017/2/13

Y1 - 2017/2/13

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.

AB - 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.

KW - Bell's palsy

KW - Child

KW - Facial nerve palsy

KW - House Brackmann scale

KW - Prednisolone

KW - Randomised controlled trial

U2 - 10.1186/s12887-016-0702-y

DO - 10.1186/s12887-016-0702-y

M3 - Article

AN - SCOPUS:85013276119

SN - 1471-2431

VL - 17

JO - BMC Pediatrics

JF - BMC Pediatrics

IS - 1

M1 - 53

ER -

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

Abstract

Keywords

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