Performing of diagnostic medical procedures needs patient’s cooperation that children often refuse it. Although behavioral training could be successful in promoting Electroencephalography (EEG) compliance without restraint or sedation, EEG recording in children not amenable to behavioral training often requires sedation. Furthermore natural sleep and sleep deprivation increases the yield of seizure activity. In our EEG clinic, Chloral hydrate is being used routinely for recording sleep EEG, however its unpleasant taste and many side effects may warrant an alternative sedative for uncooperative children. In this study, we compare oral form of Clonidin, Melatonin and Midazolam with Chloral hydrate for sedation induction in 400 children aged: between 1 month to 72 months. Study outcomes included neurological diagnosis, sleep onset latency, sleep duration, drowsiness time and adverse drug events that may happen in the first 24 h after EEG. Drug effects on EEG background and yield of epileptic discharges is very important and we consider it; these finding will be recorded for future interpretation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106286907N1
Registration date:2011-10-01, 1390/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-01, 1390/07/09
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2012-01-01, 1390/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral Midazolam, Clonidin and Melatonin with Chloral hydrate for recording sleep EEG in children
Public title
Comparison of oral Midazolam, Clonidin and Melatonin with Chloral hydrate for recording sleep EEG in children
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria; non cooperative children aged between 1 month to 72 months and patients that refered for Sleep EEG.
Exclusion criteria ; Hypersensensivity to Chloral hydrate, Melatonin, Midazolam and Clonidin; hepatic or renal diseases; severe cardiac disease; peptic ulcer; severe tonsillar or adenoid hypertrophy and being under treatment with medications that have serious interaction with these drugs .
Age
To 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
400
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
Ethics Committe of Tehran University of Medical Sciences
Street address
Tehran-pour sina avenu-Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
90/130/956
Health conditions studied
1
Description of health condition studied
Induction of sedation for recording sleep EEG
ICD-10 code
G40.9
ICD-10 code description
Epilepsy, unspecified
Primary outcomes
1
Description
Time to sleep, Sleep duration and time to awakeness
Timepoint
Immediately after consumption
Method of measurement
Examination
Secondary outcomes
1
Description
Possible side effect of drugs
Timepoint
While treatment
Method of measurement
Questionaire
Intervention groups
1
Description
Midazolam prescribed as oral solution(Amsed oral liquid 2.5 mg in 1 ml) 0.5 mg/kg/dose .
Category
Treatment - Drugs
2
Description
Clonidin prescribed as tablet( 0.2mg) 2-4 microgram/kg/dose .
Category
Treatment - Drugs
3
Description
Chloral hydrate prescribed as solution of 10% 1cc/kg/dose
Category
Treatment - Drugs
4
Description
Parents informed that to put their children to sleep 2 h later than the usual time , awaken them at 6.00 am and not to let them fall asleep until the time of EEG recording . Melatonin prescribed as Syrup (KidNaps oral liquid 1 mg in1ml ) 2-6 mg/dose .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center - EEG Department
Full name of responsible person
Dr. Firozeh Hosseini ,Fellowship of Child Neurology
Street address
Children's Medical Center, Dr Gharib Avenue
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Rostamabadi
Street address
Sixth floor, Central bulding of Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Behinpad Company
Full name of responsible person
Dr Marjan Dibayan
Street address
No 505, Behrouz Street, Mirdamad avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behinpad Company
Proportion provided by this source
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
Tehran University of Medical Sciences
Full name of responsible person
Mahmoudreza Ashrafi
Position
Professor Of Pediatric Neurology
Other areas of specialty/work
Street address
Children's Medical Center, Dr Gharib Avenue
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 5848
Fax
+98 21 6693 5848
Email
ashrafim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)