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. Resumen Neurotóxina A botulínica preoperatoria para niños con parálisis cerebral bilateral que van a ser sometidos a una cirugía mayor de cadera: un ensayo aleatorio, doble ciego, controlado con placebo Objetive Evaluar si la neurotóxina A botulínica preoperatoria (BoNT‐A) afecta el dolor después de una cirugía mayor de cadera en niños con parálisis cerebral bilateral (PC). Método Este fue un ensayo aleatorio, con brazos paralelos, controlado con placebo. Los niños con PC hipertónica de 2 a 15 años de edad que esperaban una cirugía de cadera en un hospital terciario se escogieron al azar para recibir inyecciones de BoNT‐A o de placebo en los músculos de la cadera una sola administración previa a la cirugía. El resultado primario fue el perfil de dolor pediátrico (PPP, siglas en ingles), que se evaluó al inicio del estudio y semanalmente durante 6 semanas. La asignación del tratamiento fue por minimización. Tanto los participantes, como los clínicos y evaluadores