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Comparison of efficacy of melatonin and oral midazolam in sedation for electroencephalography of children

Protocol summary

Summary
In a clinical trial, efficacy and safety of melatonin and oral midazolam in induction of sedation of 80 children 1-10years old referred to electroencephalography unit, will be evaluated. The patients will randomly be assigned to receive either 0.3 mg/kg/dose of melatonin or 0.75mg/kg oral midazolam until Ramsay score of four is attained and recording of EEG is done successfully. Vital signs, cyanosis, respiratory state, apnea and any side effect will be evaluated in children for two hours after drug use. Efficacy of drugs in sedation induction, time to induction of sedation, total stay time in EEG unit, serious adverse events (hypotension, hypoxia and cyanosis, severe vomiting, irritability, apnea, laryngospasm, and bradycardia), and caregiver’s satisfaction are also compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107182639N5
Registration date: 2011-07-24, 1390/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-24, 1390/05/02
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
Deputy for research of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Expected recruitment start date
2011-07-23, 1390/05/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of melatonin and oral midazolam in sedation for electroencephalography of children
Public title
Melatonin and oral midazolam in sedation for electroencephalography of children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age 1-18 years old; children who are referred to EEG center but don’t obey, , class 1 or 2 of ASA Exclusion criteria: Presence of gastritis or any other serious systemic diseases, use of sedative in two days ago ; occurrence of severe systemic reaction wth drugs
Age
From 1 year old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences,Yazd,Iran
Street address
Yazd, Bahonar square, central building university
City
Yazd
Postal code
Approval date
2011-07-13, 1390/04/22
Ethics committee reference number
44447/1/17/پ

Health conditions studied

1

Description of health condition studied
Epilepsy
ICD-10 code
G40- G47
ICD-10 code description
Episodic and paroxysmal disorders

Primary outcomes

1

Description
sedation induction with achieving of a level of four on the Ramsay scale
Timepoint
every 15 minutes
Method of measurement
clinical

2

Description
success in recording of EEG
Timepoint
one hour after drug use
Method of measurement
clinical

Secondary outcomes

1

Description
serious adverse events (hypotension, hypoxia and cyanosis, severe vomiting, irritability, apnea, laryngospasm, and bradycardia)
Timepoint
every 10 minutes
Method of measurement
clinical

2

Description
side effects
Timepoint
every 15 minutes
Method of measurement
clinical

3

Description
time to induction of sedation
Timepoint
every 15 minutes
Method of measurement
clinical

4

Description
caregiver’s satisfaction scale
Timepoint
after 2 hours of drug use
Method of measurement
asking from caregiver

5

Description
total stay time in EEG unit
Timepoint
every 30 minutes
Method of measurement
asking from parents

Intervention groups

1

Description
oral melatonin 0.3 mg/kg/dose
Category
Other

2

Description
oral midazolam 0.75mg/kg/dose
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi hospital - EEG unit
Full name of responsible person
Dr. Razieh Fallah
Street address
Shahid Sadoughi Hospital, Sina Blvd, Shahid Ghandi Blvd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research -Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Full name of responsible person
Dr. Fatemeh Ezoddini Ardakani
Street address
Bahonar square, central building of university
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research -Shahid Sadoughi University of Medical Sciences , 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
associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Sina Blvd, Shahid Ghandi Blvd
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)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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