]>
IRCT20190208042654N5 IRCT 2022-02-22 Esfahan University of Medical Sciences Evaluation of the effectiveness of Cyproheptadine on paroxysmal short-time headache in children Evaluation of the effectiveness of Cyproheptadine on paroxysmal short-time headache in children between 2 to 15 years of age: A single-arm clinical trial 2022-04-04 anticipated 20 Complete https://irct.ir/trial/61526 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Episodic Paroxysmal hemicrania. Intervention group: Cyproheptadine 0.2 to 0.4 mg per kg bodyweight of the child is given in two divided doses for the child. Cyproheptadine is available in the form of 4 mg tablets and 2 mg syrup in 5 ml. These pills are purchased domestically from Jalinus pharmaceutical company and are prescribed to all patients from the same drug brand. In addition to prescribing medication to all patients, the necessary recommendations will be made about the factors that may increase the severity and frequency of headaches, such as dietary, physical, and psychological causes.. 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 It is not yet known if there will be a plan to make this available.
public Jafar Nasiri
Emam Khomeini Ave
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 Nasiri.jafar@gmail.com Esfahan University of Medical Sciences scientific Jafar Nasiri
Emam Khomeini Ave
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 Nasiri.jafar@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children with 2 to 15 years of age Children with episodic paroxysmal hemicrania referred to neurology clinic whose disease has been definitively diagnosed according to the ICHD criteria. Number of attacks of equal or more than once a week 2 years 15 years Both Patients' unwillingness to cooperate during the study Severe and uncontrollable side effects of cyproheptadine If, based on possible laboratory or imaging findings, a diagnosis other than episodic paroxysmal hemicrania is made during the study Epilepsy or epileptic headaches Existence of structural anomalies in MRI imaging History of allergies to similar drugs Inability to record data on the number, duration, and severity of headaches Taking a prophylactic drug other than Cyproheptadine Severe psychiatric problems such as depression or ADHD G44.03 Episodic paroxysmal hemicrania Treatment - Drugs Intervention group: Cyproheptadine 0.2 to 0.4 mg per kg bodyweight of the child is given in two divided doses for the child. Cyproheptadine is available in the form of 4 mg tablets and 2 mg syrup in 5 ml. These pills are purchased domestically from Jalinus pharmaceutical company and are prescribed to all patients from the same drug brand. In addition to prescribing medication to all patients, the necessary recommendations will be made about the factors that may increase the severity and frequency of headaches, such as dietary, physical, and psychological causes. Frequency, duration, and severity of headache attacks and drug side effects. Timepoint: before intervention and each month after intervention. Method of measurement: Checklist includes measuring the number of attacks per week, the duration of attacks in form of minutes and its severity according to the VAS criteria and the occurrence of known side effects. Esfahan University of Medical Sciences Approved 2022-02-21 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)