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IRCT20181014041338N2 IRCT 2023-01-22 Shiraz University of Medical Sciences Effect of Melatonin in treatment of Pediatric Status Epilepticus Evaluation of The Effect of Melatonin on Treatment of Pediatric Refractory and Super-Refractory Generalized Convulsive Status Epilepticus in 1 to 15 years old Children 2023-02-01 anticipated 40 Complete https://irct.ir/trial/65199 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the allocation of melatonin to patients, block randomization method (two blocks of 20, one for receiving melatonin and one for not receiving melatonin) is used, the unit of which is individual. To achieve this goal, web-based randomization (www.randomization.com website) is used to randomly determine how 40 patients are placed in two groups of 20 (randomly placing numbers 1 to 40 in two groups of 20), Blinding description: In this study, single blinding is used and only participants (patients and their legal guardians) have been kept blind. Since the patients are minors and the informed consent for participating in the study is obtained from their parents/guardians, the parent/guardian will also be blinded to receiving or not receiving melatonin. The other people involved in the study are all aware of the allocation or non-allocation of melatonin to patients. Since this is a pilot study and melatonin will be used after two antiseizure drugs and simultaneously with anesthetic drugs and in patients with decreased level of consciousness (through nasogastric tube), placebo will not be used in the control group. 2-3 Pediatric status epilepticus. Intervention 1: Intervention group:. Intervention 2: Control group:. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hamid Nemati
Namazi sq, Shiraz, Fars,
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 meshham5@gmail.com Shiraz University of Medical Sciences scientific Hamid Nemati
Namazi sq, Shiraz, Fars,
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3647 4332 meshham5@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 1 to 15 years old children admitted in Namazi hospital PICU diagnosed with refractory and super-refractory generalized convulsive status epilepticus 1 year 15 years Both Dissent of patient's legal guardian regarding administration of melatonin. Inability to use NG tube for any reason. Occurrence of adverse drug reaction to melatonin. G40.411 Other generalized epilepsy and epileptic syndromes, intractable, with status epilepticus Treatment - Drugs Treatment - Drugs Intervention group: Control group: Cessation of generalized convulsive status epilepticus. Timepoint: Continuous 24-hour monitoring from the moment the patient enters the pediatric intensive care unit. Method of measurement: Clinical observation by PICU's attending physician and staff. Shiraz University of Medical Sciences Approved 2022-06-14 Ethics committee of shiraz University of Medical Sciences Zand St., Shiraz, Iran shiraz Fars Iran (Islamic Republic of)