Investigation and comparison of sedative effects of ketofol and midazolam-ketamine combination in endoscopy of upper gastrointestinal tract in children 1 to 14 years
Investigation and comparison of sedative effects of ketofol and midazolam-ketamine combination in endoscopy of upper gastrointestinal tract in children 1 to 14 years
Design
In this interventional study, 54 patients who met the inclusion criteria were selected and divided into two groups using block randomization method (n=27 in each group). Proper counseling were done and a written informed consent were obtained before starting the treatment regimen.
Settings and conduct
The present study was performed on 54 children aged 1 to 14 years who referred to the pediatric gastroenterology center of Taleghani Hospital in Gorgan in 2014. The first group received ketamine 1 mg / kg and 1 mg / kg propofol and the second group received 0.5 mg / kg midazolam and 2 mg / kg ketamine intravenously and by slow injection. Systolic, diastolic blood pressure and heart rate were measured before and after 5, 10, 30, and 60 minutes after sedation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for endoscopy, age 1 to 14 years old. Exclusion criteria: Cardiopulmonary disease
Intervention groups
Intervention group:Use of 1 mg /kg ketamine (Pfizer Co. Germany) and 1 mg /kg propofol (Tehranchemie Co. product) . Control group: Use of 0.05 mg / kg midazolam (Caspian Tamin Co. Iran)and 2 mg /kg ketamine (Pfizer Co. Germany) .
Main outcome variables
Systolic and diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200620047853N1
Registration date:2020-06-22, 1399/04/02
Registration timing:retrospective
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Vahid Adiban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 1410
Email address
v.adiban@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
2014-08-23, 1393/06/01
Actual recruitment end date
2014-12-22, 1393/10/01
Trial completion date
2014-12-22, 1393/10/01
Scientific title
Investigation and comparison of sedative effects of ketofol and midazolam-ketamine combination in endoscopy of upper gastrointestinal tract in children 1 to 14 years
Public title
Investigation and comparison of sedative effects of ketofol and midazolam-ketamine combination in endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for endoscopy
Age 1 to 14 years old
Exclusion criteria:
Cardiopulmonary disease
Age
From 1 year old to 14 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly were assigned to one of two identified groups through blockade.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the physician who examined the patients did not be aware of the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Shastkola, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2013-11-17, 1392/08/26
Ethics committee reference number
237192082602
Health conditions studied
1
Description of health condition studied
Endoscopy
ICD-10 code
Y61.4
ICD-10 code description
During endoscopic examination
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before and 5, 10, 30 and 60 minutes after sedation
Method of measurement
Barometer
2
Description
Diastolic blood pressure
Timepoint
Before and 5, 10, 30 and 60 minutes after sedation
Method of measurement
Barometer
Secondary outcomes
1
Description
Heart rate
Timepoint
Before and 5, 10, 30 and 60 minutes after sedation
Method of measurement
Heart rate count
Intervention groups
1
Description
Intervention group: Use of 1 mg /kg ketamine and 1 mg /kg propofol
Category
Treatment - Drugs
2
Description
Control group: Use of 0.05 mg / kg midazolam and 2 mg / kg ketamine at
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Vahid Adiban
Street address
Taleghani Hospital, Janbazan Blvd, Gorgan
City
Gorgan
Province
Golestan
Postal code
4916668197
Phone
+98 17 3222 7720
Email
v.adiban@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Masood Khoshnia
Street address
Deputy of Research & Technology, Golestan University of Medical Sciences, Shastcola, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 2651
Email
drkhniya@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?