Protocol summary

Summary
In a clinical trial, efficacy and safety of promethazine and chloral hydrate in induction of sedation of 60 children 1-18 years old referred to electroencephalography unit, will be evaluated. The patients will randomly be assigned to receive either 100 mg/kg/dose of chloral hydrate or 1mg/kg promethazine until Ramsay score of four is attained. If the child is not sedated after 30 minutes of drug use, the second dose of drug in half of the first dose will be administered. Vital signs, level of consciousness, cyanosis, respiratory state, vomiting, dystonia, and extra pyramidal 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 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: IRCT138903032639N2
Registration date: 2010-05-24, 1389/03/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-05-24, 1389/03/03
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 Shaheed Sadoughi University of Medical Sciences and Health Services, Yazd, Iran
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of oral chloral hydrate and promethazine in sedation induction for electroencephalography in children
Public title
Comparison of effectiveness of chloral hydrate and promethazine in electroencephalography
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: children who are referred to EEG center but don’t obey, age 1-18 years old, class 1 or 2 of ASA Exclusion criteria: Presence of gastritis or any other serious systemic diseases, severe systemic 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
Boali street, Safaeeh
City
Yazd
Postal code
Approval date
2010-05-04, 1389/02/14
Ethics committee reference number
14693/1/17/پ

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

Secondary outcomes

1

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

2

Description
level of consciousness based on GCS number
Timepoint
every 15 minutes
Method of measurement
clinical exam

3

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

4

Description
vital signs(blood pressure , pulse rate , respiratory rate
Timepoint
every 10 minutes
Method of measurement
clinical exam

5

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

6

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

7

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

8

Description
Efficacy of drugs in sedation induction for EEG
Timepoint
after 2 hours of drug use
Method of measurement
asking from parents

Intervention groups

1

Description
Promethazin, 1mg/kg single dose, Orally
Category
Treatment - Drugs

2

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Sadoughi hospital - EEG unit
Full name of responsible person
Dr. Razieh Fallah
Street address
Shaheed 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 and Health Services
Full name of responsible person
Dr. Fatemah Ezodinee
Street address
Bahonar Square
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 and Health Services
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
Shaheed Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr. Razieh Fallah
Position
Assistant professor
Other areas of specialty/work
Street address
Shaheed 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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