Comparison of efficacy and safety of chloral hydrate, combination of chloral hydrate - promethazine and combination of chloral hydrate - hydroxyzine in sedation induction for electroencephalography of children
In a clinical trial, efficacy and safety of chloral hydrate, combination of chloral hydrate - promethazine and combination of chloral hydrate - hydroxyzine in sedation induction of 90 children 1-7 years old referred to electroencephalography unit, will be evaluated. The patients will randomly be assigned to receive single dose either 40 mg/kg of chloral hydrate or combination 1mg/kg promethazine and 40 mg/kg of chloral hydrate or combination 1mg/kg hydroxyzine and 40 mg/kg of chloral hydrate until Ramsay score of four is attained. Vital signs and adverse effect will be evaluated in children for one hour after drug use. Efficacy of drugs in adequate sedation induction, time to induction of adequate sedation, total stay time in EEG unit , side effects and caregiver’s satisfaction are also compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204262639N8
Registration date:2012-07-28, 1391/05/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-28, 1391/05/07
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid sadoughi Medical Sciences University
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of chloral hydrate, combination of chloral hydrate - promethazine and combination of chloral hydrate - hydroxyzine in sedation induction for electroencephalography of children
Public title
chloral hydrate, combination of chloral hydrate - promethazine and combination of chloral hydrate - hydroxyzine in sedation induction for electroencephalography of children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
1. Children who are referred to EEG center but don’t obey,
2. Age 1-7 years old
3. Class 1 or 2 of ASA
Exclusion criteria:
1. Presence of gastritis or any other serious systemic diseases
2. Severe systemic reaction
3. History of allergy to drug
4. The patient does not use the drug completely
Age
From 1 year old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ali-ebn-Abitaleb School of Medicine, Islamic Azad University, Yazd Branch, Yazd, Iran
Street address
Danesh amose square, near to Shah Vali Hospital
City
Yazd
Postal code
Approval date
2012-07-08, 1391/04/18
Ethics committee reference number
105101091302009
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40, G47
ICD-10 code description
Epilepsy and paroxysmal disorders
Primary outcomes
1
Description
success in recording of EEG
Timepoint
every 15 minutes
Method of measurement
clinical exam
2
Description
adequate sedation (Ramsay score of four is attained)
Timepoint
every 15 minutes
Method of measurement
clinical exam
Secondary outcomes
1
Description
total stay time in EEG unit
Timepoint
every 30 minutes
Method of measurement
asking from parents
2
Description
side effects
Timepoint
every 15 minutes
Method of measurement
clinical exam
3
Description
time to induction of adequate sedation
Timepoint
every 15 minutes
Method of measurement
clinical exam
4
Description
caregiver’s satisfaction
Timepoint
after one hour of drug use
Method of measurement
asking from caregiver
Intervention groups
1
Description
combibation of 1mg/kg hydroxyzine and 40 mg/kg of chloral hydrate
Category
Treatment - Other
2
Description
combination 1mg/kg promethazine and 40 mg/kg of chloral hydrate
Category
Treatment - Other
3
Description
single dose 40 mg/kg of chloral hydrate
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Neurology Clininc of Shahid sadoughi Medical Sciences University
Full name of responsible person
Dr.Razieh Fallah
Street address
Taleghani BLVD
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ali-ebn-Abitaleb School of Medicine, Islamic Azad University, Yazd Branch, Yazd, Iran
Full name of responsible person
Dr.razieh Fallah
Street address
Shahid Sadoughi Hospital
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ali-ebn-Abitaleb School of Medicine, Islamic Azad University, Yazd Branch, Yazd, Iran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences ,Yazd,Iran
Full name of responsible person
Dr.Razieh Fallah
Position
Pediatric neurologist , Associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)