The comparison assessment of sedative effect of intravenous ktamine and midazolam versus oral combination of midazolam and ketamin for dagnostic upper gastrointestinal endoscopy in children
The comparison assessment of sedative effect of intravenous ketamine and midazolam versus oral combination of midazolam and ketamin for diagnostic upper gastrointestinal endoscopy in children
Design
Randomized clinical trial with parallel groups. 100 patients have randomly divided into intervention groups A and B with a table of random numbers and Randomizer software.
Settings and conduct
The population of this study was aged 3-16 years old who referred to Children's Hospital Decedent Shafi'zadeh Amirkola in Babol. Patients are randomly divided into two Intervention groups with a table of random numbers by computer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients have not underlying problem, age 3 -16 years old.
Exclusion criteria: respiratory, heart, kidney or liver diseases; apparent neurological inability; hypersensitivity to Benzodiazepines.
Intervention groups
Intervention group 1: Oral Midazolam (Exir Company) 0.5 mg / kg with a maximum dose of 20 mg and intramuscular Ketamine (Tritau Company) with a dose of 0.5 mg / kg. Intervention group 2: Oral Midazolam (Exir Company) 0.5 mg / kg with a maximum dose of 20 mg and oral ketamine (Tritau Company) with a dose of 5 mg / kg up to a maximum of 70 mg.
Main outcome variables
Sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043750N2
Registration date:2020-05-14, 1399/02/25
Registration timing:registered_while_recruiting
Last update:2020-05-14, 1399/02/25
Update count:0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
mohammad esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8305
Email address
dresmaeili48@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison assessment of sedative effect of intravenous ktamine and midazolam versus oral combination of midazolam and ketamin for dagnostic upper gastrointestinal endoscopy in children
Public title
Sedative effect for diagnostic upper gastrointestinal endoscopy in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have not underlying problem
Age 3 -16 years old
Patients are randomly divided into three groups A and B with a table of random numbers (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized. The participants allocation sequence in two groups performed with a Randomizer software.
Blinding (investigator's opinion)
Not 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 Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2020-01-19, 1398/10/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.329
Health conditions studied
1
Description of health condition studied
Sedation in endoscopy
ICD-10 code
Y60.4
ICD-10 code description
During endoscopic examination
Primary outcomes
1
Description
Sedation
Timepoint
During and 1 hour after endoscopy
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Oral Midazolam (Exir Company) 0.5 mg / kg with a maximum dose of 20 mg and intramuscular Ketamine (Tritau Company) with a dose of 0.5 mg / kg
Category
Treatment - Drugs
2
Description
Intervention group 2: Oral Midazolam (Exir Company) 0.5 mg / kg with a maximum dose of 20 mg and oral ketamine (Tritau Company) with a dose of 5 mg / kg up to a maximum of 70 mg