The aim of this study was to find the right dose of sedative drugs to achieve the appropriate level of sedation in children below 2 years who suffer from head trauma and require CT scan. Inclusion criteria was children below 2 years old and suffer from head trauma. Exclusion criteria were anticipated difficult airway; history of adverse reactions to benzodiazepines; hemodynamic instability ... This clinical trial conducted on 120 children below 2 years. In this study, two different doses of intravenous administration of midazolam (0.1mg / kg and 0.3mg / kg) in two 60-member groups were compared with each other. Variables include the mean score of Ramsay, duration and effect of sedative drugs, oxygen saturation, respiratory rate and pulse rate and complications. Children were enrolled to study who had three sedation level or higher, after administration of midazolam. Additional doses of midazolam will administrated five minutes later in cases with not desired level of sedation, and if no response haven't observed, ketamine will administrated. Then the studied variables were analyzed in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092121289N2
Registration date:2015-11-01, 1394/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-01, 1394/08/10
Registrant information
Name
Akram Rohani Marvasti
Name of organization / entity
Ahvaz,Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 7207
Email address
rohani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Ahvaz Jundishapur University of Medical Sciences
Faculty of Medicine
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-20, 1395/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedative effect of two different doses of midazolam, 0.1mg/kg and 0.3mg/kg for brain CT-scan in children aged under 2 old years
Public title
Comparison medicinal doses of midazolam in sedation of children under 2 years for brain CT scan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Children under 2 years old; suffered from head trauma; and have permission to do brain CT scan.
Exclusion criteria include anticipated difficult airway; history of adverse reactions to benzodiazepines; hemodynamic instability; congestive heart failure; liver disease; impaired level of consciousness (defined as a Glasgow coma scale less than 15); uncontrolled vomiting; gastric esophageal reflux history; concomitant use of drugs and uremia.
Age
From 1 day old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine
Street address
Khuzestan, Ahvaz, Iran - Golestan highway - opposite the Khuzestan Water and Power Authority (five classes) - the main door of Ahvaz University of Medical Sciences and Health Services
City
ahvaz
Postal code
6135715794
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
GP93044
Health conditions studied
1
Description of health condition studied
Sedation of children for CT scan
ICD-10 code
Z00.0, Z00
ICD-10 code description
General medical examination, Routine child health examination
Primary outcomes
1
Description
Ramsay sedation score (RSS)
Timepoint
Initiation of intervention
Method of measurement
Ramsay sedation score (RSS)
Secondary outcomes
1
Description
Duration and impact of sedation medication
Timepoint
first day
Method of measurement
Monitor and measure
2
Description
Oxygen saturation
Timepoint
first day
Method of measurement
Measurement of arterial blood gases
3
Description
respiratory and pulse rate
Timepoint
first day
Method of measurement
Monitor and measure
4
Description
complications
Timepoint
The first day until the seventh day
Method of measurement
Monitor and measure
Intervention groups
1
Description
Patients in the first group a dose of 0.1 mg / kg intravenous midazolam were injected during the study, children at a dose of midazolam 0.1mg / kg and 0.3mg / kg for them, was not sufficient to perform process, injection up to a maximum of 3 times was performed. Interval between doses was at least 5 minutes.
Category
Treatment - Drugs
2
Description
Patients in the second group, a dose of 0.3 mg / kg intravenous midazolam were injected during the study, children at a dose of midazolam 0.1mg / kg and 0.3mg / kg for them, was not sufficient to perform process, injection up to a maximum of 3 times was performed. Interval between doses was at least 5 minutes.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Shima Zeynoddini
Street address
City
ahvaz
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Shima Zeynoddini
Street address
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research deputy of Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine
Full name of responsible person
Nader Saki
Street address
The main door of Ahvaz University of Medical Sciences and Health Services- opposite the Khuzestan Water and Power Authority (five classes)- Golestan highway- Ahvaz- Khuzestan- Iran
City
ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research deputy of Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine
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
Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine
Full name of responsible person
Hasan Barzegar
Position
Assistant Professor
Other areas of specialty/work
Street address
The main door of Ahvaz University of Medical Sciences and Health Services- opposite the Khuzestan Water and Power Authority (five classes)- Golestan highway- Ahvaz- Khuzestan- Iran
City
ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
h-b1979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine
Full name of responsible person
Hasan Barzegar
Position
Assistant Professor
Other areas of specialty/work
Street address
The main door of Ahvaz University of Medical Sciences and Health Services- opposite the Khuzestan Water and Power Authority (five classes)- Golestan highway- Ahvaz- Khuzestan- Iran
City
ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
h-b1979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine
Full name of responsible person
Shima Zeinodini
Position
resident of Emergency Medicine
Other areas of specialty/work
Street address
The main door of Ahvaz University of Medical Sciences and Health Services- opposite the Khuzestan Water and Power Authority (five classes)- Golestan highway- Ahvaz- Khuzestan- Iran
City
ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
meymandshima@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)