The comparison of premedication effect of intranasal Ketamin and Midazolam in sedation and ease of separation from parents in children 2-6 years old admitted for elective urological surgery
The aim of study is the comparison of premedication effect of intranasal Ketamin and Midazolam in sedation of children and ease of separation from parents. The children ages 2-6 years old admitted for elective urological surgery at Razi educational hospital of Rasht. This study will be performed on 70 uncooperative children. All children fasted for 8 hours before being transferred to the operating room (OR). Before entering OR at randomized blocks children divided into two groups (Ketamin and Midazolam). Thirty minutes before entering operating in group Ketamin: intranasal Ketamin 5mg/kg maximum 1 cc in each nostril and in group Midazolam: intaranasal Midazolam 0/5mg/kg with the same volume is administered. Drugs are administered with syringe 2 cc in each nostril while patients are in supine position. All patients' physiological parameters are controlled and recorded before and after drug administration and every 5 minutes until transferring of the patient to the operating room. At the time of the transfer of the patient to the OR, ease of separation from parents, on the basis of four-point scale and the degree of sedation in children based on a 5-point scale is checked. All patients receive similar general anesthesia. Recovery time and postoperative complications include nausea and vomiting will be checked in all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016082411766N4
Registration date:2016-09-21, 1395/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-21, 1395/06/31
Registrant information
Name
Hossein Khoshrang
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
khoshrang@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Guilan University of Medical Sciences
Expected recruitment start date
2016-10-11, 1395/07/20
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of premedication effect of intranasal Ketamin and Midazolam in sedation and ease of separation from parents in children 2-6 years old admitted for elective urological surgery
Public title
The comparison of premedication effect of intranasal Ketamin and Midazolam in sedation of children and ease of separation from parents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children 2 to 6 years old with the weight of 10-20 kg;No history of allergy to any of the medications;No history of central nervous system drugs;
Lack of disease involving the central nervous system, or psychological disorders
Exclusion criteria:Emergency surgery;children or their parents refuse to take the medicine; estimate that duration of surgery is less than 1 hour or more than 3 hours.
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti free way.apposite of Sepah bank, Building of vice chancellor of research of Guilan University of Medical Sciences
City
Rasht
Postal code
4193713194
Approval date
2016-05-10, 1395/02/21
Ethics committee reference number
IR.GUMS.REC.1395.49
Health conditions studied
1
Description of health condition studied
social anxiety disorder of childhood
ICD-10 code
F93.2
ICD-10 code description
Social anxiety disorder of childhood
Primary outcomes
1
Description
Sedation of children
Timepoint
During transfer to the operating room
Method of measurement
based on 5-point scale
2
Description
Facilitate the separation of children from parents
Timepoint
During transfer to the operating room
Method of measurement
based on 4-point scale
3
Description
Recovery time
Timepoint
Since time to enter recovery unit until exit from recovery unit
Method of measurement
Time(in minutes)
Secondary outcomes
1
Description
post operation side effects(nausea,vomiting, apnea,hallucination)
Timepoint
In recovery unit
Method of measurement
Yes/No
Intervention groups
1
Description
Intervention 1: Intaranasal Midazolam 0.5mg/kg are administered.Ampule Midazolam with 5mg/cc Midazolam produced by Caspian company, Iran.
Category
Prevention
2
Description
Intervention 2: Intranasal Ketamin 5mg/kg are administered.Vial ketamin with 50mg/cc Ketamin hydrocchloride produced by TRITTAU company, Germany
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital of Rasht
Full name of responsible person
Hossein Khoshrang
Street address
Razi hospital,Sardar e Jangal Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research of Guilan University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Building of vice chancellor of research of Guilan University of Medical Sciences,Shahid Beheshti free way.apposite of Sepah bank,
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Hossein Khoshrang
Position
associate professor of Anesthesiology
Other areas of specialty/work
Street address
Sardar Jangal Street, Razi hospital
City
Rasht
Postal code
41488
Phone
+98 13 3335 9974
Fax
+1 333368534
Email
khoshrang@gums.ac.ir, hkhoshrang@yahoo.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hossein Khshrang
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Razi hospital,Sardar Jangal Street
City
Rasht
Postal code
001333559974
Phone
+98 13 3366 6775
Fax
+1 333368534
Email
khoshrang@gums.ac.ir, hkhoshrang@yahoo.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedye Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina hospital, Poursina transection
City
Rasht
Postal code
4193713194
Phone
+98 13 3332 3970
Fax
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)