Preoperative botulinum neurotoxin A for children with bilateral cerebral palsy undergoing major hip surgery: a randomized double-blind placebo-controlled trial.

Abstract

To assess whether preoperative botulinum neurotoxin A (BoNT-A) affects pain after major hip surgery for children with bilateral cerebral palsy (CP). This was a randomized, parallel arms, placebo-contolled trial. Children with hypertonic CP aged 2 to 15years awaiting bony hip surgery at a tertiary hospital were randomized to receive either BoNT-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 6weeks. Treatment allocation was by minimization. Participants, clinicians, and outcome assessors were masked to group assignment. Twenty-seven participants (17 males, 10 females; mean 8y 8mo [SD 3y 9mo], range 3y 4mo-15y 10mo) were allocated to BoNT-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 6weeks for the BoNT-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 6months of follow-up (n=6 in BoNT-A group). Use of BoNT-A immediately before bony hip surgery for reducing postoperative pain for children with CP was not supported. Botulinum neurotoxin A (BoNT-A) does not reduce postoperative pain following bony hip surgery. BoNT-A also does not affect postoperative quality of life.