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IRCT20220211053995N1 IRCT 2022-02-20 Mashhad University of Medical Sciences The effect of Botulinum type A on sialorrhea in patients with cerebral palsy The effect of Botulinum toxin type A on reducing sialorrhea in patients with cerebral palsy in Akbar Children's Hospital 2022-02-20 anticipated 20 Complete https://irct.ir/trial/61985 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 2 cerebral palsy; sialorrhea. 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.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no more information.
public Seyed Javad Sayedi
Akbar Children's Hospital., Kaveh Blvd., TV square
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3870 9201 nazariradm991@mums.ac.ir Mashhad University of Medical Sciences scientific seyed Javad Sayedi
Akbar Children's Hospital., Kaveh Blvd., TV square
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3870 9201 nazariradm991@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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 4 years 16 years Both 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. G80 Cerebral palsy Treatment - Other 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. 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. 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. Mashhad University of Medical Sciences Approved 2021-10-19 Ethics committee of Mashhad University of Medical Sciences Akbar Children's Hospital., Kaveh Blvd., TV square Mashhad Razavi Khorasan Iran (Islamic Republic of)