The effect of botulinum toxin type A on reducing sialorrhea in cerebral palsy patients in Akbar Children's Hospital
Design
A single group study clinical trial, phase 2 on 20 patients and outcome assessment
Settings and conduct
The present study is a clinical trial performed in Akbar Children's Hospital. Vial toxin botulinum A 30 to 50 units (less than 15 kg 30 units, between 15 to 25 kg 40 units and more than 25 kg 50 units) depending on the patient's weight is injected into the salivary glands by an ear,nose and throat specialist under an ultrasound guide.
Participants/Inclusion and exclusion criteria
Patients with cerebral palsy; between 4 and 16 years old; with a Frequency drooling scale score 4 and Severity and Teacher drooling scale more than 4 are included in this study.
Patients with contraindications of botulinum toxin A injection; history of botulinum toxin A injection for at least the past 4 months are excluded from the study.
Intervention groups
Children with cerebral palsy
Injection of botulinum toxin type A in the salivary glands of children with cerebral palsy
Main outcome variables
Outcomes associated with botulinum toxin injection (intensity and frequency of drooling) are assessed using Drooling Frequency or severity scale and teacher drooling scale before, 2 weeks, 1 month, 2 months, 4 months, 6 months and 9 months after injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220211053995N1
Registration date:2022-02-20, 1400/12/01
Registration timing:registered_while_recruiting
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Mehrnaz Nazarirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3602 8805
Email address
nazariradm991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Botulinum toxin type A on reducing sialorrhea in patients with cerebral palsy in Akbar Children's Hospital
Public title
The effect of Botulinum type A on sialorrhea in patients with cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with cerebral palsy
Drooling frequency scale 4 and severity and Teacher scale more than 4
Age between 4 and 16 years
Consent of parents or legal guardians to enter the study
Exclusion criteria:
Contraindications of botulinum toxin A injection such as myasthenia gravis and Eaton-Lambert syndrome
Botulinum toxin A injection for at least the last four months
Receiving systemic medication to treat sialorrhea in the last three months
Recent maxillofacial surgery that may interfere with saliva production and flow.
Age
From 4 years old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Akbar Children's Hospital., Kaveh Blvd., TV square
City
Mashhad
Province
Razavi Khorasan
Postal code
91778 99191
Approval date
2021-10-19, 1400/07/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.535
Health conditions studied
1
Description of health condition studied
cerebral palsy; sialorrhea
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Drooling frequency score based on Drooling frequency scale and Teacher drooling scale
Timepoint
Before intervention, 2 weeks, 1 month, 2 months, 4 months, 6 months and 9 months after botulinum toxin injection
Method of measurement
Drooling Frequency and Teacher drooling scale
2
Description
Drooling severity score based on Drooling severity scale and Teacher drooling scale
Timepoint
Before intervention, 2 weeks, 1 month, 2 months, 4 months, 6 months and 9 months after botulinum toxin injection
Method of measurement
Drooling Severity and Teacher drooling scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vial toxin botulinum type A (massport) diluted with 3.2 cc of normal saline and depending on the patient's weight in each salivary gland 30 to 50 units (less than 15 kg 30 units, between 15 to 25 kg 40 Units and more than 25 kg 50 units) are injected by an ear, nose and throat specialist under an ultrasound guide.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Seyed Javad Sayedi
Street address
Akbar Children's Hospital., Kaveh Blvd., TV square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3803
Email
nazariradm991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Akbar Children's Hospital., Kaveh Blvd., TV square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9201
Email
nazariradm991@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Javad Sayedi
Position
Associate Professor of Pediatric Pulmonology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital., Kaveh Blvd., TV square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9201
Email
nazariradm991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
seyed Javad Sayedi
Position
Associate Professor of Pediatric Pulmonology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital., Kaveh Blvd., TV square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9201
Email
nazariradm991@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Javad Sayedi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital., Kaveh Blvd., TV square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9201
Email
nazariradm991@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available