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Original research
Pain in children with Bell’s palsy: secondary analysis of a randomised controlled trial
  1. Franz E Babl1,2,3,4,
  2. Nitaa Eapen1,3,
  3. David Herd5,6,
  4. Meredith L Borland7,8,
  5. Amit Kochar9,10,
  6. Ben Lawton11,
  7. Jason Hort12,
  8. Adam West13,
  9. Shane George14,15,
  10. Andrew Davidson1,2,16,
  11. John A Cheek1,2,3,
  12. Ed Oakley1,2,3,4,
  13. Sandy M Hopper1,2,3,
  14. Robert G Berkowitz1,
  15. Catherine L Wilson1,
  16. Amanda Williams1,
  17. Mark T MacKay1,2,
  18. Katherine J Lee1,2,17,
  19. Stephen Hearps1,4,
  20. Stuart R Dalziel18,19
  1. 1 Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia
  2. 2 Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia
  3. 3 Emergency Department, The Royal Children's Hospital, Parkville, Victoria, Australia
  4. 4 Department of Critical Care, University of Melbourne, Parkville, Victoria, Australia
  5. 5 Emergency Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia
  6. 6 University of Queensland, Brisbane, Queensland, Australia
  7. 7 Emergency Department, Perth Children's Hospital, Nedlands, Perth, Australia
  8. 8 Divisions of Paediatrics and Emergency Medicine, University of Western Australia, Crawley, Western Australia, Australia
  9. 9 Department of Acute Care Medicine, University of Adelaide, Adelaide, South Australia, Australia
  10. 10 Emergency Department, Women's and Children's Hospital, North Adelaide, South Australia, Australia
  11. 11 Emergency Department, Logan Hospital, Brisbane, Queensland, Australia
  12. 12 Emergency Department, The Children's Hospital at Westmead, Sydney, New South Wales, Australia
  13. 13 Emergency Department, Monash Medical Centre, Clayton, Victoria, Australia
  14. 14 Department of Emergency Medicine, Gold Coast University Hospital, Southport, Queensland, Australia
  15. 15 School of Medicine and Menzies Health Institute Queensland, Griffith University, Southport, Queensland, Australia
  16. 16 Department of Anesthesia and Pain Management, Royal Children's Hospital, Parkville, Victoria, Australia
  17. 17 Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia
  18. 18 Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand
  19. 19 Departments of Surgery and Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand
  1. Correspondence to Dr Franz E Babl, Emergency Department, Royal Children's Hospital, Parkville, VIC 3052, Australia; franz.babl{at}rch.org.au

Abstract

Objective To describe the prevalence and severity of pain experienced by children with Bell’s palsy over the first 6 months of illness and its association with the severity of facial paralysis.

Methods This was a secondary analysis of data obtained in a phase III, triple-blinded, randomised, placebo-controlled trial of prednisolone for the treatment of Bell’s palsy in children aged 6 months to <18 years conducted between 13 October 2015 and 23 August 2020 in Australia and New Zealand. Children were recruited within 72 hours of symptom onset and pain was assessed using a child-rated visual analogue scale (VAS), a child-rated Faces Pain Score-Revised (FPS-R) and/or a parent-rated VAS at baseline, and at 1, 3 and 6 months until recovered, and are reported combined across treatment groups.

Results Data were available for 169 of the 187 children randomised from at least one study time point. Overall, 37% (62/169) of children reported any pain at least at one time point. The frequency of any pain reported using the child-rated VAS, child-rated FPS-R and parent-rated VAS was higher at the baseline assessment (30%, 23% and 27%, respectively) compared with 1-month (4%, 0% and 4%, respectively) and subsequent follow-up assessments. At all time points, the median pain score on all three scales was 0 (no pain).

Conclusions Pain in children with Bell’s palsy was infrequent and primarily occurred early in the disease course and in more severe disease. The intensity of pain, if it occurs, is very low throughout the clinical course of disease.

Trial registration number ACTRN12615000563561.

  • Paediatrics
  • Paediatric Emergency Medicine
  • Child Health
  • Emergency Care

Data availability statement

No data are available.

https://doi.org/10.1136/archdischild-2023-325381

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    Data availability statement

    No data are available.

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    Footnotes

    • Twitter @MeredithBorland, @paedsem

    • Contributors FEB conceived the study, obtained grant funding, designed the original RCT, provided overall supervision, interpreted the data and is responsible for the overall content as guarantor. FEB and NE wrote the initial draft of the paper. DH, MLB, AK, BL, JH, AWe, SG, JAC, EO, SH, SMH, RB, AWi, MTM and SD designed the study, obtained the data, provided supervision, interpreted the data and revised the manuscript critically. NE, AD and CLW designed the study, interpreted the data and revised the manuscript critically. KL designed the study, supervised the analysis of the data, interpreted the data and revised the manuscript critically. SH analysed the data, interpreted the data and revised the manuscript critically. All authors agreed to be accountable for all aspects of the work.

    • Funding The study was funded by a grant from the National Health and Medical Research Council (NHMRC, project grant GNT1078069), Canberra, Australia, the Emergency Medicine Foundation (EMSS-312R26-2016), Brisbane, Australia, and the Perth Children’s Hospital Foundation project grant (9670), Perth, Australia. The PREDICT research network was part funded by an NHMRC Center of Research Excellence grant (GNT1058560), Canberra, Australia, the Murdoch Children’s Research Institute, Melbourne, Australia, and the Victorian Government’s Operational Infrastructure Support programme. FEB’s time was part funded by a grant from the Royal Children’s Hospital Foundation, Melbourne, Victoria, Australia, and an NHMRC Practitioner Fellowship. SD’s time was part funded by the Health Research Council of New Zealand (HRC13/556) and Cure Kids, Auckland, New Zealand. Aspen Australia (St Leonards NSW 2065, Australia) provided the study drug (prednisolone and taste matched placebo) as a donation free of charge. Aspen did not sponsor the study and had no influence on study design, execution, analysis and publication.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.