ANZCTR - Registration

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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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cerebral palsy

Condition category

Condition code

Neurological

Other neurological disorders

Musculoskeletal

Other muscular and skeletal disorders

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The motor function of the patients was evaluated using the gross motor function classification system.

Timepoint [1]

Evaluation of primary outcome is made 1 week after administration of each dose.

Secondary outcome [1]

Complications observed in patients during the procedure were obtained using the medical records of the patients.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Izmir

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

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

Ethics committee address [1]

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]

Turkey

Date submitted for ethics approval [1]

04/02/2019

Approval date [1]

14/02/2019

Ethics approval number [1]

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

Dr Murat Celal Sözbilen

Address

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

Phone

+902324116000

Fax

+902324892315

[email protected]

Contact person for public queries

Name

Kubra Evren Sahin

Address

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

Phone

+902324116000

Fax

+902324892315

[email protected]

Contact person for scientific queries

Name

Kubra Evren Sahin

Address

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

Phone

+902324116000

Fax

+902324892315

[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.	Type	Citation	Link	Email	Other Details	Attachment
9827	Study protocol					380968-(Uploaded-27-11-2020-23-14-38)-Study-related document.DOC
9829	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Long-term efficacy and safety of repeated botulinum toxin a applications based on function and anesthesia type in children with cerebral palsy.	2022	https://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.

Trial Review

Documents added manually

Documents added automatically