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Evaluation of Repeated Botulinum Toxin A Applications According To Different Anesthesia Types and Gross Motor Function in Children With Cerebral Palsy

Evaluation of the Safety and Efficacy of Repeated Botulinum Toxin A Applications Under Different Anaesthesia Types for Gross Motor Function in Children With Cerebral Palsy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001744842
Enrollment
75
Registered
2021-12-20
Start date
2020-01-01
Completion date
2020-05-01
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this study, it was aimed to compare the functional outcomes and different anesthesia types applied in patients who received repeated BoNT-A. Serial BoNT-A is now a routine form of application in improving function and movement in children with cerebral palsy, which requires the repetitive anesthesia applications to be reliable and effective. While repeated BoNT-A application in children with CP provides progress in motor steps, it can be applied safely and effectively under anesthesia. Sedation analgesia application provides easier recovery compared to general anesthesia with LMA and masks only in the first three applications. However, recovery time increases with 4 and more repeated applications as the number of applications increases.

Interventions

In this study, cerebral palsy patients who applied to our hospital for BoNT-A administration between January 2008 and 2018 were retrospectively included. It was aimed to compare the different anesthesia types and functional results in patients who received repeated BoNT-A (2 units/0.1 ml) (Serial BoNT-A administration method intramuscular injection). A total of 3 doses were administered once every 6 months. Three types of anesthesia methods (intra venous midazolam 0.1 mg/kg, intravenous ketamine

In this study, cerebral palsy patients who applied to our hospital for BoNT-A administration between January 2008 and 2018 were retrospectively included. It was aimed to compare the different anesthesia types and functional results in patients who received repeated BoNT-A (2 units/0.1 ml) (Serial BoNT-A administration method intramuscular injection). A total of 3 doses were administered once every 6 months. Three types of anesthesia methods (intra venous midazolam 0.1 mg/kg, intravenous ketamine 0.5 mg/kg sedation analgesia, general anesthesia with laryngeal mask airway (LMA), general anesthesia with anesthesia mask) were applied to the patients during the procedures. Anesthesia applications were started approximately 5 minutes before the BoNT-A injection and stopped immediately after the injection. Side effects, recovery time and total operation time were compared.

Sponsors

University of Health Sciences Izmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Spastic hemiplegic cerebral palsy patients who applied to the orthopedic clinic of our hospital for botox application in the last 10 years and underwent botulinum toxin A application under anesthesia in operating room conditions will be included in the study. Patients who underwent botulinum toxin A in the orthopedic clinic of our hospital between January 2008 and January 2018 were included in the study.

Exclusion criteria

Patients who received BoNT-A once or twice between January 2008 and January 2018 were excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026