A pilot feasibility study of gabapentin for managing pain in children with dystonic cerebral palsy

Abstract

Background: Gabapentin is often used to manage pain in children with dystonic cerebral palsy, however the evidence for its effectiveness in this population is limited. The primary objective of this feasibility pilot study was to assess the factors which might impact on a future randomised controlled trial including the ability to recruit and retain participants, assess adherence/compliance to the prescribed intervention, and ability to complete all outcome assessments. The secondary objective was to gather preliminary evidence for the effectiveness of gabapentin at reducing pain, improving comfort and reducing dystonia in children with dystonic cerebral palsy.; Methods: This open label pilot study recruited children aged 5-18 years with dystonic cerebral palsy and accompanying pain affecting daily activities from four centres around Australia. Children were prescribed gabapentin for 12 weeks and were assessed at baseline, 6 weeks and 12 weeks. The primary outcome was feasibility of the protocol. Secondary outcomes were pain behaviour, pain intensity, care and comfort, individualised goal setting and dystonia severity.; Results: Thirteen children (mean age 10.4 years (SD 2.4yrs), 9 females) were recruited from 71 screened over 15 months. Two children withdrew while eight children experienced side effects. There were issues with adherence to medication dosage regimens and data collection. Improvements were seen in pain behaviour, comfort and pain related goals at 12 weeks. Dystonia was not significantly changed.; Conclusions: Whilst gabapentin has potential to improve pain and comfort in children with dystonic CP, the feasibility of implementing a definitive randomised controlled trial is low. Alternative trials designs are required to further examine the effectiveness of gabapentin in this heterogeneous population.; Trial Registration: The trial was registered with the Australian Clinical Trial Registry ( ACTRN12616000366459 ) on 22/03/2016 and the Therapeutic Goods Administration (CT-2016-CTN-00500-1) on 22/06/2016. (© 2021. The Author(s).)Dev Med Child Neurol. 2004 Jan;46(1):9-18. (PMID: 14974642); Dev Med Child Neurol. 1999 Jun;41(6):404-11. (PMID: 10400175); Eur J Paediatr Neurol. 2016 Jan;20(1):100-7. (PMID: 26455274); Pediatrics. 2015 Oct;136(4):e947-60. (PMID: 26416940); Dev Med Child Neurol. 2006 Mar;48(3):181-7. (PMID: 16483393); Dev Med Child Neurol. 2018 Sep;60(9):861-865. (PMID: 29882358); Dev Med Child Neurol. 2017 Aug;59(8):858-863. (PMID: 28509356); Health Qual Life Outcomes. 2003 Oct 16;1:54. (PMID: 14613568); Pediatrics. 2003 Jan;111(1):e89-97. (PMID: 12509602); Dev Med Child Neurol. 2019 Mar;61(3):305-314. (PMID: 30508221); J Paediatr Child Health. 2018 Apr;54(4):401-404. (PMID: 29105865); Pediatrics. 2013 Aug;132(2):e407-13. (PMID: 23858420); Acta Paediatr. 2010 Mar;99(3):446-51. (PMID: 20003101); Dev Med Child Neurol. 2010 May;52(5):e83-7. (PMID: 20540176); Dev Med Child Neurol. 2018 Apr;60(4):356-366. (PMID: 29405267); Dev Med Child Neurol. 2006 Oct;48(10):804-12. (PMID: 16978459); Paediatr Anaesth. 2005 May;15(5):412-20. (PMID: 15828994). Linking ISSN: 14712431. Subset: MEDLINE; Date of Electronic Publication: 2021 Aug 28. ; Original Imprints: Publication: London : BioMed Central, [2001- <br />