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Preoperative botulinum neurotoxin A for children with bilateral cerebral palsy undergoing major hip surgery: a randomized double‐blind placebo‐controlled trial
Author(s) -
Will Elspeth,
Magill Nicholas,
Arnold Rebecca,
Davies Megan,
Doherty Gary,
Fairhurst Charlie,
Roposch Andreas,
Lundy Claire,
NormanTaylor Fabian
Publication year - 2019
Publication title -
developmental medicine and child neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.658
H-Index - 143
eISSN - 1469-8749
pISSN - 0012-1622
DOI - 10.1111/dmcn.14145
Subject(s) - medicine , cerebral palsy , placebo , anesthesia , randomized controlled trial , confidence interval , surgery , adverse effect , physical therapy , alternative medicine , pathology
Aim To assess whether preoperative botulinum neurotoxin A (Bo NT ‐A) affects pain after major hip surgery for children with bilateral cerebral palsy ( CP ). Method This was a randomized, parallel arms, placebo‐contolled trial. Children with hypertonic CP aged 2 to 15 years awaiting bony hip surgery at a tertiary hospital were randomized to receive either Bo NT ‐A or placebo injections into the muscles of the hip on a single occasion immediately before surgery. The primary outcome was the paediatric pain profile ( PPP ), which was assessed at baseline and weekly for 6 weeks. Treatment allocation was by minimization. Participants, clinicians, and outcome assessors were masked to group assignment. Results Twenty‐seven participants (17 males, 10 females; mean 8y 8mo [ SD 3y 9mo], range 3y 4mo–15y 10mo) were allocated to Bo NT ‐A and 27 participants (14 males, 13 females; mean 8y 11mo [ SD 3y 5mo], range 4y 1mo–15y 2mo) to placebo. Mean ( SD ) PPP at 6 weeks for the Bo NT ‐A group ( n =24 followed up) was 10.96 (7.22) and for the placebo group ( n =26) was 10.04 (8.54) ( p =0.69; 95% confidence interval [ CI ] –4.82, 3.18). There were 16 serious adverse events in total during 6 months of follow‐up ( n =6 in Bo NT ‐A group). Interpretation Use of Bo NT ‐A immediately before bony hip surgery for reducing postoperative pain for children with CP was not supported. What this paper adds Botulinum neurotoxin A (BoNT‐A) does not reduce postoperative pain following bony hip surgery. BoNT‐A also does not affect postoperative quality of life.