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Comparison between the effect of oral chloral hydrate and intranasal Fentanyl on pediatric sedation for EEG .

Protocol summary

Study aim
identification of the effect of oral chloral hydrate and intranasal Fentanyl on pediatric sedation for EEG .
Design
The study is randomized by random allocation , random numbers into 2groups with31 patients.first group gets 50mg/kg oral chloral hydrate ,30 minutes before EEG and 2µg/kg intra nasal normal saline as placebo. 2nd group gets 2µg/kg intra nasal fentanyl,30 minutes before EEG and50mg/kg oral placebo with the same appearance to oral chloral hydrate. It is a randomized clinical trial with control groups, parallel groups , blinded ,randomized by random numbers.
Settings and conduct
this is a randomized clinical trial randomized by random numbers and two side blinded which will be done in emam hossein hospital isfahan 2019-2020.
Participants/Inclusion and exclusion criteria
enter:Children between 3months to 3years Candidate for EEG under sedation. exit: cancelling of EEG after administration of drug for any reason,drug reactions , respiratory problems
Intervention groups
first group gets 50mg/kg oral chloral hydrate ,30 minutes before EEG and 2µg/kg intra nasal normal saline as placebo. 2nd group gets 2µg/kg intra nasal fentanyl,30 minutes before EEG and50mg/kg oral placebo with the same appearance to oral chloral hydrate.
Main outcome variables
hemodynamic changes (systolic blood pressure,diastolic blood pressure, mean arterial pressure ,heart rate), degree of sedation by RAMSEY scale, before getting drugs, at 1,3,5,10 minutes after drug administration at the time of EEG and every 10 minutes in recovery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191205045618N1
Registration date: 2020-03-16, 1398/12/26
Registration timing: registered_while_recruiting

Last update: 2020-03-16, 1398/12/26
Update count: 0
Registration date
2020-03-16, 1398/12/26
Registrant information
Name
amir khodarahmi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3622 5453
Email address
amirkhodarahmi1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-14, 1399/03/25
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 Fentanyl on pediatric sedation for EEG .
Public title
Comparison between the effect of oral chloral hydrate and intranasal Fentanyl on sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children between 3 months to years candidated for EEG
Exclusion criteria:
cancelling of EEG after administration of drug drug allergy respiratory problems
Age
From 3 months old to 3 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
random allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicines are Delivered and Coded in Equal Volumes by the Researcher and the Anesthesiologist dose not know the groups
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Isfahan University Medical Science
Street address
Building No.4, Isfahan University of Medical Sciences, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
IR.MUI.MED.REC.1398.359

Health conditions studied

1

Description of health condition studied
mean arterial pressure,o2 saturation,heart rate, respiratory rate ,degree of sedation by RAMSEY scale
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
mean arterial pressure
Timepoint
before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery
Method of measurement
monitoring by manometer

2

Description
heart rate
Timepoint
before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery
Method of measurement
monitoring by palseoxymeter

3

Description
degree of sedation
Timepoint
before administration of drugs, 1,3,5,10 minutes after administration at the time if EEG, every 10 minutes in recovery
Method of measurement
RAMSEY scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: first group gets 50mg/kg oral chloral hydrate ,30 minutes before EEG and 2µg/kg intra nasal normal saline as placebo
Category
Treatment - Drugs

2

Description
Intervention group: 2nd group gets 2µg/kg intra nasal fentanyl,30 minutes before EEG and50mg/kg oral placebo with the same appearance to oral chloral hydrate.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Amir Shafa
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
815163381
Phone
+98 31 3386 6566
Email
emamhossein_hospital@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 9017
Email
sh_haghjoo@med.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
Amir Shafa
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
amir_shafa@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomeini
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Email
amir_shafa@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Khomeini
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 9141
Fax
Email
amir_shafa@med.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
information of participants and results of the study
When the data will become available and for how long
1 year after publish of the letter
To whom data/document is available
all of the researchers that are interested to have access to these information
Under which criteria data/document could be used
by sending request
From where data/document is obtainable
the projects admin
What processes are involved for a request to access data/document
by email
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