Objectives: comparison and study of efficacy and side effects of intravenous and intramuscular ketamine for sedation of 1 to 6 years old children, setting and conduct: this Clinical Trial Study that done on 272 patients in case and control groups, we give intravenous ketamine for sedation to the control group and so the case group will receive intramuscular ketamine for sedation, Inclusion criteria: need for sedation to imaging; age below 6 years old Exclusion criteria: history of hypersensitivity to ketamine; evidences of abnormal brain; evidence of rise of intracranial pressure; history of apnea and respiratory disorders; history of severe traumatic brain injury; no sedation with standard dose; parental disagreement Observation: time to start sedation; sedation grade; blood pressure changes; vomiting; apnea; laryngospasm; in the case and control group Primary outcome measure: time to start sedation and grade of sedation comparison in each group will be done
General information
Acronym
Comparison Between Intravenous and Intramuscular Ketamine for Sedation of Children
IRCT registration information
IRCT registration number:IRCT2016021826630N1
Registration date:2016-03-04, 1394/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-04, 1394/12/14
Registrant information
Name
Arash Forouzan
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2043
Email address
arash-forouzan@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistant of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Efficacy and Side Effects of Intravenous and Intramuscular Ketamine for Sedation of 1 to 6 Years Old Children
Public title
Comparison Between Efficacy and Side Effects of Intravenous and Intramuscular Ketamine for Sedation of 1 to 6 Years Old Children
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: need for sedation to imaging; age below 6 years old Exclusion criteria: history of hypersensitivity to ketamine; evidences of abnormal brain; evidence of rise of intracranial pressure; history of apnea and respiratory disorders; history of severe traumatic brain injury; no sedation with standard dose; parental disagreement
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
272
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
Ethics Committee of Ahvaz University of Medical Sciences
Street address
Research Assistant, Next to central Building, Ahvaz Jundishapur University of Medical Sciences, University town, Ahvaz
City
Ahvaz
Postal code
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
ir.ajums.rec.1394.431
Health conditions studied
1
Description of health condition studied
Traumatic subdural haemorrhage
ICD-10 code
S06.5
ICD-10 code description
Traumatic subdural haemorrhage
2
Description of health condition studied
Epidural haemorrhage
ICD-10 code
S06.4
ICD-10 code description
Epidural haemorrhage
3
Description of health condition studied
Traumatic subarachnoid haemorrhage
ICD-10 code
S06.6
ICD-10 code description
Traumatic subarachnoid haemorrhage
Primary outcomes
1
Description
Time to start sedation
Timepoint
immediately after infusion of drug
Method of measurement
minutes
2
Description
Grade of sedation
Timepoint
1 minute after infusion, 5 minutes after infusion, 15 minutes after infusion
Method of measurement
Ramsay Sedation Scale
Secondary outcomes
1
Description
Vomiting
Timepoint
Up to one hour after infusion of drug
Method of measurement
Observation
2
Description
Apnea
Timepoint
Up to 15 minutes after infusion of drug
Method of measurement
Observation
3
Description
Seizure
Timepoint
Up to 15 minutes after infusion of drug
Method of measurement
Observation
Intervention groups
1
Description
Control group: 1.5 mg per kilogram intravenous ketamine
Category
Other
2
Description
Case group: 4 milligram per kilogram of body weight intramuscular ketamine
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Arash Forouzan
Street address
Azadi Street
City
Ahvaz
2
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr Arash Forouzan
Street address
Golestan Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice challencor for reasearch of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice challencor for reasearch of Ahvaz Jundishapur University 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arash Forouzan
Position
Assistant Professor of Emergency Medcine
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
arash-forouzan@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arash Forouzan
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Emergency Medicine Department, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
Arash-Forouzan@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Arash Forouzan
Position
Emergency Medicine Assistant Professor
Other areas of specialty/work
Street address
Emergency Medicine department, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
arash-forouzan@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)