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Comparison of efficacy of oral chloral hydrate and intranasal midazolam in sedation for CT scan in children

Protocol summary

Summary
In a clinical trial, efficacy and safety of intranasal midazolam and oral chloral hydrate in induction of sedation of 60 children 1-18 years old referred to Ct scan unit of Shahid Sadoughi Hospital , will be evaluated. The patients will randomly be assigned to receive either 75 mg/kg/dose of chloral hydrate or 0.2mg/kg intranasal midazolam until Ramsay score of four is attained. Vital signs and adverse 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 CT 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: IRCT201107082639N4
Registration date: 2011-07-21, 1390/04/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-07-21, 1390/04/30
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 of research -Shaheed 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 oral chloral hydrate and intranasal midazolam in sedation for CT scan in children
Public title
oral chloral hydrate and intranasal midazolam in sedation induction for CT scan
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:age 1-18 years old; children who are referred to CT scan center but don’t obey; class 1 or 2 of ASA Exclusion criteria: use of chloral hydrate or midazolam in recently 48 hours ; gastritis or any other serious systemic diseases ; history of drugs allergy ; occurrence of severe systemic drugs reaction
Age
From 1 year old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shaheed Sadoughi University of Medical Sciences and Health Services
Street address
Bahonar square , central building on University
City
Yazd
Postal code
Approval date
2011-06-26, 1390/04/05
Ethics committee reference number
39321/1/17/پ

Health conditions studied

1

Description of health condition studied
other disorders of the nervous system
ICD-10 code
G90-G99
ICD-10 code description
Other disorders of the nervous system

Primary outcomes

1

Description
sedation until Ramsay score of four be attained
Timepoint
every 15 minutes
Method of measurement
clinical

2

Description
Efficacy of drugs in sedation induction
Timepoint
every 15 minutes
Method of measurement
clinical exam

Secondary outcomes

1

Description
side effects
Timepoint
every 15 minutes
Method of measurement
clinical exam

2

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

3

Description
vital signs(blood pressure , pulse rate , respiratory rate
Timepoint
every 15 minutes
Method of measurement
clinical exam

4

Description
time to induction of sedation,
Timepoint
eyery 30 minutes
Method of measurement
clinical exam

5

Description
total stay time in CT scan unit
Timepoint
after 2 hours of drug use
Method of measurement
asking from parents

6

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

Intervention groups

1

Description
Chloral hydrate, 70 mg/kg single dose, orally
Category
Treatment - Drugs

2

Description
intranasal midazolam, 0.2mg/kg single dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi hospital - CT scan 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 -Shaheed Sadoughi University of Medical Sciences ,Yazd,Iran
Full name of responsible person
Dr. Fatemah Ezodinee
Street address
Bahonar Square ,University central byilding
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 -Shaheed 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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