Evaluation of the effectiveness of botulinum toxin type A injection in reducing salivation and improving quality of life in patients with cerebral palsy
Determining the effect of botulinum toxin type A on reducing salivation and quality of life in patients with cerebral palsy in Imam Hossein Hospital, Isfahan
Design
Clinical trial in which the control group is patients before injection; non-blinded; non-random; About 30 patients
Settings and conduct
First, 500 units of botulinum toxin type A (Botox®, Masport, Iran) are diluted with 3 ml of normal saline.
The child is placed in the supine position so that the head can be rotated to both sides, then in each of the parotid and submandibular glands 0.5 units per kilogram by an ENT specialist under ultrasound guide by a radiologist without anesthesia؛ Is injected. Needle number 25G is used for injection.
These procedures are performed in the operating room of Imam Hossein Hospital in Isfahan.
Participants/Inclusion and exclusion criteria
Patients with cerebral palsy; Intensity score and salivation more than 4; No contraindication to injection; No receive systemic saliva-reducing drug and Botox injection in the previous three months; No recent maxillofacial surgery related to salivation
Intervention groups
Botox injection in parotid and submandibular glands in patients with cerebral palsy
Main outcome variables
Quality of life with Teacher drooling scale
Severity of salivation with Drooling Frequency and Severity scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054868N1
Registration date:2022-09-22, 1401/06/31
Registration timing:retrospective
Last update:2022-09-22, 1401/06/31
Update count:0
Registration date
2022-09-22, 1401/06/31
Registrant information
Name
Mohadese Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 5759
Email address
ghasemi.mhds@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-26, 1401/04/05
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of botulinum toxin type A injection in reducing salivation and improving quality of life in patients with cerebral palsy
Public title
The effect of botulinum toxin type A on reducing salivation and quality of life in patients with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Affliction cerebral palsy
Drooling score more than 4
Exclusion criteria:
Contraindications for injection of Botulinum toxin A
Botulinum toxin type A injection in three month ago
Perform recent maxillofacial surgery that may interfere with saliva production and flow
Receive systemic medication to treat sialorrhea in the last three months
Age
From 1 year old to 16 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
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 Isfahan University of Medical Sciences
The amount and intensity of saliva secretion based on drooling frequency and severity score
Timepoint
drooling frequency and severity Score before injection, 2 weeks after injection, one month, 2 months, 4 months and 6 months after injection
Method of measurement
drooling frequency and severity Score
Secondary outcomes
1
Description
Quality of life score related to salivation based on a questionnaire
Timepoint
Before injection, 2 weeks after injection, one month, 2 months, 4 months and 6 months after injection
Method of measurement
Teacher drooling scale
Intervention groups
1
Description
Intervention group: For patients with cerebral palsy, first 500 units of botulinum toxin type A (Botox®, Masport, Iran) is diluted with 3 ml of normal saline. The child is placed in the supine position so that the head can rotate in both directions, then 0.5 units per kilogram of body weight are injected into each of the parotid and submandibular glands by an ENT specialist under an ultrasound guide by a radiologist without anesthesia. Needle number 25G is used for injection. This operation is performed in the operating room of the hospital.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mohadeseh Ghasemi
Street address
Imam Hossein Hospital, Imam Khomeini Street
City
Isfahan
Province
Isfehan
Postal code
8195163318
Phone
+98 31 3386 6266
Email
emamhossein_hospital@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansoor Siavash
Street address
Building No. 4,Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?