Comparison between the effect of oral chloral hydrate and intranasal dexmedetomidine on pediatric sedation for EEG in Isfahan Imam Hossein Hospital, in 2017
The aim of this study is comparing the effect of chloral hydrate with dexmedetomidine on sedation for patients in EEG
Design
Clinical trial, phase 2, double blind, 60 patients between 3 month to 3 years old admitted based on EEG, randomized in two groups of chloral hydrate and dexmedetomidine.
Settings and conduct
This is a double blinded study on 60 patients admitted in EEG ward in Emam Hossein hospital of Isfahan, who receive chlore hydrate or dexmedetomidine will be compared about sedation
Participants/Inclusion and exclusion criteria
The patients With age of 3 months to 3 years who need EEG and without sensitivity to chloral hydrat and dexmedetomidine and with ASA1, ASA2
Intervention groups
The patient under EEG
Main outcome variables
Ramsy score scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180520039739N3
Registration date:2019-04-22, 1398/02/02
Registration timing:registered_while_recruiting
Last update:2019-04-22, 1398/02/02
Update count:0
Registration date
2019-04-22, 1398/02/02
Registrant information
Name
Mohammadreza Habibzadeh siahroodkolaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3532 0551
Email address
M.habibzadeh@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of oral chloral hydrate and intranasal dexmedetomidine on pediatric sedation for EEG in Isfahan Imam Hossein Hospital, in 2017
Public title
Comparison between the effect of oral chloral hydrate and intranasal dexmedetomidine on pediatric sedation for EEG
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age of 3 month to 3 years
Patients who need EEG
patients with ASA1,ASA2
Exclusion criteria:
Sensitivity to dexmedetomidine or chloral hydrate in past medical histoty
Age
From 3 months old to 3 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization (random number table): even numbers for chlor hydrate and odds for dexmedetomidine
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and their nurses are not aware of the kind of drug and executor of plan will give the drug to thr nurses
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan university of medical sciences
Street address
Esfahan university of medical sciences,hezarjarib Ave.
City
Esfahan
Province
Isfehan
Postal code
ندارد
Approval date
2017-04-25, 1396/02/05
Ethics committee reference number
IR.MUI.REq.1396.39975
Health conditions studied
1
Description of health condition studied
Sedation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
In One houre
Method of measurement
Ramsy score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with 50 mg/kg chloral hydrate 10% ( Kimia teb pajohan gharb)30 minute before EEG
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with 2 micro/kg dexmedetomidine (behestan daro) 30 minute before EEG
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hosein hospital in esfahan
Full name of responsible person
Mohammad reza habibzadeh
Street address
Emam khomeini Ave
City
Esfahan
Province
Isfehan
Postal code
ندارد
Phone
+98 31 3532 0551
Email
Gsmhabibzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo javanmard
Street address
Hezarjatib Ave
City
Esfahan
Province
Isfehan
Postal code
Phone
+98 31 3532 0551
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hezarjarib Ave
City
Esfahan
Province
Isfehan
Postal code
8158384177
Phone
+98 31 3532 0551
Email
Gsmhabibzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mphammadreza habibzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hezarjarib Ave
City
Esfahan
Province
Isfehan
Postal code
8158384177
Phone
+98 31 3532 0551
Email
Gsmhabibzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza habibzadeh
Position
Assistant professore
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Hezajarib Ave
City
Esfahan
Province
Isfehan
Postal code
8158384177
Phone
+98 31 3532 0551
Email
Gsmhabibzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available