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

AIM: To assess whether preoperative botulinum neurotoxin A (BoNT-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 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 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 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 6 weeks 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 6 months of follow-up (n=6 in BoNT-A group). INTERPRETATION: Use of BoNT-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.