Format

Send to

Choose Destination
Dev Med Child Neurol. 2019 Jan 15. doi: 10.1111/dmcn.14145. [Epub ahead of print]

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

Author information

1
Evelina London Children's Hospital, London, UK.
2
Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.
3
Royal Belfast Hospital for Sick Children, Belfast, UK.
4
Institute of Child Health, University College London, London, UK.

Abstract

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.

PMID:
30644541
DOI:
10.1111/dmcn.14145

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center