The purpose of this study is to compare the safety and efficacy of oral midazolam and midazolam–promethazine combination to sedate children less than 7 years old undergoing CT-scan. We evaluated efficiency of them based on age and sex and weight, sedation scores,onset and duration of sleep and hemodynamic changes.children aged less than 7 years who who scheduled for CT scan and are placed under sedation enter this study and if there are history of allergy to the ingredients used or having neurological or vascular defects excluded. Children who entered this study are randomly allocate into two groups: Group P receive oral promethazine (1.25 mg.kg-1) with midazolam (0.5 mg.kg-1), and Group M receive oral placebo with midazolam (0.5 mg.kg-1) alone.Sedation scores,onset and duration of sleep are evaluate.Adverse effects,including hypoxemia,failed sedation ,and the return of based activity,will documented.Statistical analysis is performed with spss software
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202279148N1
Registration date:2013-01-21, 1391/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-01-21, 1391/11/02
Registrant information
Name
Hassan Barzegari
Name of organization / entity
Golestan Hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3079
Email address
barzegari-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundi Shapur University Of Medical Sciences
Expected recruitment start date
2011-09-21, 1390/06/30
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral sedation with midazolam and promethazine compared with midazolam in children less than 7 years old undergoing CT-scan
Public title
comparison of oral promethazine plus oral midazolam and oral midazolam in children sedation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: children aged less than 7 years who were scheduled for CT scan and are placed under sedation
Exclusion criteria: history of allergy to the ingredients used - having neurological defects and vascular defects
Age
To 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Technology Department of Ahwaz Jondishapur Univercity Of Medical Sciences
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ETH-371
Health conditions studied
1
Description of health condition studied
sedation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
onset and duration of sleep
Timepoint
Continuously until the onset of drug effects
Method of measurement
observe of the patient and determine the level of consciousness
beats per minute - respiratory per minute - mm Hg - percent
Intervention groups
1
Description
Intervention group: they will be recive syrup promethazine 1.25 mg/kg orally one hour before the CT scan is done. Then a dose of o.5mg/kg oral midazolam 20 minutes before CT (mixed with fruit juice) is given.If vomiting occurs within 15 minutes of administration of midazolam, we again repeat the dose. Children who do not sleep 30 minutes after midazolam administration 50% of the initial dose of midazolam should take to complete.
Category
Treatment - Drugs
2
Description
control group: they will be receive Sugar syrup 0.5 mg/kg orally one hour before the CT scan is done.Then a dose of o.5mg/kg oral midazolam 20 minutes before CT (mixed with fruit juice) is given.If vomiting occurs within 15 minutes of administration of midazolam, we again repeat the dose. Children who do not sleep 30 minutes after midazolam administration 50% of the initial dose of midazolam should take to complete.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Hassan Barzegari
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Ahwaz Jondishapur Univercity Of Medical Sciences
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jondishapur Univercity Of Medical Sciences
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
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Dr. Hassan Barzegari
Position
Emergency Medicine Specialist / Assistant Professor
Other areas of specialty/work
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
h_b1979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Dr Hassan Barzegari
Position
Emergency Medicine Specialist /Assistant Professor
Other areas of specialty/work
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
h_b1979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jondishapur Univercity Of Medical Sciences
Full name of responsible person
Dr. Hassan Barzegari
Position
Emergency Medicine Specialist /Assistant Professor
Other areas of specialty/work
Street address
Ahwaz Jondishapur Univercity Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
h_b1979@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)