Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001744842
Ethics application status
Approved
Date submitted
27/11/2020
Date registered
20/12/2021
Date last updated
20/12/2021
Date data sharing statement initially provided
20/12/2021
Date results information initially provided
20/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Repeated Botulinum Toxin A Applications According To Different Anesthesia Types and Gross Motor Function in Children With Cerebral Palsy
Scientific title
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
Secondary ID [1] 302833 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 319802 0
Condition category
Condition code
Neurological 317729 317729 0 0
Other neurological disorders
Musculoskeletal 317730 317730 0 0
Other muscular and skeletal disorders
Anaesthesiology 317731 317731 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
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.
Intervention code [1] 320811 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325769 0
The motor function of the patients was evaluated using the gross motor function classification system.
Timepoint [1] 325769 0
Evaluation of primary outcome is made 1 week after administration of each dose.
Secondary outcome [1] 404396 0
Complications observed in patients during the procedure were obtained using the medical records of the patients.
Timepoint [1] 404396 0
Evaluation of secondary outcome is made 1 week after administration of each dose.

Eligibility
Key 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.
Minimum age
1 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who received BoNT-A once or twice between January 2008 and January 2018 were excluded from the study.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
When the sampling error is ± 0.05 and the prevalence is 0.0036, the sample size is 53.32.
It is planned to use SPSS package program for statistical analysis. Following descriptive statistics, a comparison will be made between groups in terms of angles showing component placements (t test if the distribution is normal, or Mann Whitney U test if not). The groups will be divided into two subgroups according to the angle of the deformity; Again, comparisons will be made between these groups. Separate groups will be created according to the surgical approach applied and angles will be compared between groups. Depending on whether the distributions are normal or not, appropriate parametric or nonparametric tests will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2020
Date of last participant enrolment
Anticipated
Actual
1/05/2020
Date of last data collection
Anticipated
Actual
1/05/2020
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 23114 0
Turkey
State/province [1] 23114 0
Izmir

Funding & Sponsors
Funding source category [1] 307256 0
Self funded/Unfunded
Name [1] 307256 0
Country [1] 307256 0
Primary sponsor type
Hospital
Name
University of Health Sciences Izmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital
Address
University of Health Sciences Izmir Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital
Ismet Kaptan District, Sezer Dogan Street, No:11, 35210 Konak / IZMIR
Country Turkey
Country
Turkey
Secondary sponsor category [1] 307876 0
None
Name [1] 307876 0
Address [1] 307876 0
Country [1] 307876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307350 0
University of Health Sciences Izmir Dr. Behcet Uz Child Disease and Pediatric Surgery Training and Research Hospital.
Ethics committee address [1] 307350 0
Dr. Behcet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11, 35210 Konak / IZMIR
Ethics committee country [1] 307350 0
Turkey
Date submitted for ethics approval [1] 307350 0
04/02/2019
Approval date [1] 307350 0
14/02/2019
Ethics approval number [1] 307350 0
2018/257

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106930 0
Dr Murat Celal Sözbilen
Address 106930 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11, 35210 Konak / IZMIR
Country 106930 0
Turkey
Phone 106930 0
+902324116000
Fax 106930 0
+902324892315
Email 106930 0
[email protected]
Contact person for public queries
Name 106931 0
Dr Kubra Evren Sahin
Address 106931 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11, 35210 Konak / IZMIR
Country 106931 0
Turkey
Phone 106931 0
+902324116000
Fax 106931 0
+902324892315
Email 106931 0
[email protected]
Contact person for scientific queries
Name 106932 0
Dr Kubra Evren Sahin
Address 106932 0
Dr. Behçet Uz Child Disease and Pediatric Surgery Training and Research Hospital Ismet Kaptan District, Sezer Dogan Street, No:11, 35210, Konak / IZMIR
Country 106932 0
Turkey
Phone 106932 0
+902324116000
Fax 106932 0
+902324892315
Email 106932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data related to the work that the editors want will be shared.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Any one who wants to reach could reach one.
Available for what types of analyses?
There is no specific type of analysis for which data are available. It can be used for any purpose.
How or where can data be obtained?
Data can be obtained from [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9827Study protocol    380968-(Uploaded-27-11-2020-23-14-38)-Study-related document.DOC
9829Ethical approval    380968-(Uploaded-27-11-2020-23-13-24)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLong-term efficacy and safety of repeated botulinum toxin a applications based on function and anesthesia type in children with cerebral palsy.2022https://dx.doi.org/10.1016/j.jor.2021.12.005
N.B. These documents automatically identified may not have been verified by the study sponsor.