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
Determining the effect of melatonin in the treatment of refractory and super-refractory generalized convulsive status epilepticus and the factors affecting it in children aged 1 to 15 years old.
This study will be conducted in the Shiraz Namazi Hospital PICU. According to the group they are placed in, the patients will or will not receive melatonin in addition to the standard treatment, and their condition will be evaluated by the pediatric ICU fellowship physician. The study is single blinded (Children and their legal guardian are not informed about the allocation of melatonin)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 1 to 15 years old admitted to Shiraz Namazi Hospital PICU with the diagnosis of refractory and super-refractory generalized convulsive status epilepticus
Exclusion criteria: 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
Intervention groups
The intervention group consists of patients with refractory and super-refractory status epilepticus who will receive standard treatment including two lines of antiseizure drugs and then melatonin at the same time as anesthetic drugs.
The comparison group consists of patients with refractory and super-refractory status epilepticus who will receive standard treatment including two lines of antiseizure drugs and then anesthetic drugs.
Main outcome variables
seizure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041338N2
Registration date:2023-01-22, 1401/11/02
Registration timing:prospective
Last update:2023-01-22, 1401/11/02
Update count:0
Registration date
2023-01-22, 1401/11/02
Registrant information
Name
hamid nemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 4508
Email address
meshham5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-01, 1401/11/12
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Melatonin in treatment of Pediatric Status Epilepticus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1 to 15 years old children admitted in Namazi hospital PICU diagnosed with refractory and super-refractory generalized convulsive status epilepticus
Exclusion criteria:
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.
Age
From 1 year old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shiraz University of Medical Sciences
Street address
Zand St., Shiraz, Iran
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2022-06-14, 1401/03/24
Ethics committee reference number
IR.SUMS.MED.REC.1401.149
Health conditions studied
1
Description of health condition studied
Pediatric status epilepticus
ICD-10 code
G40.411
ICD-10 code description
Other generalized epilepsy and epileptic syndromes, intractable, with status epilepticus
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
2
Description
Control group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Meshkat Nemati
Street address
Namazi Sq, shiraz, fars.
City
shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
Web page address
https://namazi.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Namazi Hospital, Namazi sq, Shiraz, Fars,
City
shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nematih@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Nemati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Namazi sq, Shiraz, Fars,
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
Email
meshham5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Nemati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Namazi sq, Shiraz, Fars,
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
Email
meshham5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Nemati
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Namazi sq, Shiraz, Fars,
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
Email
meshham5@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD