The comparison of premedication effect of intra-nasal dexmedetomidine and intra-nasal midazolam in sedation, anxiety level and ease of separation from parents in children 2-8 years of age admitted for elective surgery in academic hospitals of Rasht in 2013
The aim of this study is to compare premedication effect of intra-nasal dexmedetomidine and midazolam in anxiety level of children 2-8 years of age admitted for elective surgery. This is a prospective study on 100 children between 2-8 years old with ASA class I, II admitted for elective surgery in Razi and Alzahra hospitals of Rasht, Iran in 2013. All children fasted for 8 hours before being transferred to the operating room (OR). Thirty minutes before transferring to OR in the presence of parents at randomized blocks children divided in two groups (D and M). In group D: Dexmedetomidine intranasal 1µg/kg and in group M: Midazolam intranasal 0.2 mg/kg is administered. Relaxation and anxiety levels of children during transferring to OR, facilitate the separation of children from their parents, tolerance of children during placement of IV access is evaluated. At the end of surgery, the time of entrance to the child's recovery until discharge is measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121611766N1
Registration date:2013-02-17, 1391/11/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-02-17, 1391/11/29
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 for research, Guilan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of premedication effect of intra-nasal dexmedetomidine and intra-nasal midazolam in sedation, anxiety level and ease of separation from parents in children 2-8 years of age admitted for elective surgery in academic hospitals of Rasht in 2013
Public title
The comparison of premedication effect of intra-nasal dexmedetomidine and midazolam in anxiety level of children 2-8 years of age admitted for elective surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children 2-8 years of age; ASA class I,II and candidate for elective surgery.
Exclusion criteria:rejection by the patient's parents; rejection drugs by children; children have allergies to any medications,history of drugs affecting the central nervous system; disease involving the central nervous system; emergent surgery and duration of surgery under 1 hour or up to 2.5 hours.
Age
From 2 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Guilan University of Medical Sciences Ethics Committee
Street address
Namjou Street
City
Rasht
Postal code
4144665385
Approval date
2012-08-06, 1391/05/16
Ethics committee reference number
1910101706
Health conditions studied
1
Description of health condition studied
Children anexitey before general anesthesia
ICD-10 code
F93.2
ICD-10 code description
social anxiety disorder of childhood
Primary outcomes
1
Description
Sedation of children before surgery
Timepoint
During transfer to the operating room
Method of measurement
Ramsay 6 point scale
2
Description
Facilitate the separation of children from parents
Timepoint
During transfer to the operating room
Method of measurement
Feld 3 point scale
3
Description
Reduction of anxiety in children before surgery
Timepoint
During transfer to the operating room
Method of measurement
4 point standard scale
Secondary outcomes
1
Description
Recovery duration
Timepoint
Enter to recovery and exit
Method of measurement
Timer
Intervention groups
1
Description
Dexmedetomidine intranasal 1µg/kg with normal saline
Category
Prevention
2
Description
Midazolam intranasal 0.2 mg/kg with normal saline
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Street address
Sardar e Jangal Ave.
City
Rasht
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
Namjoo St.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Centre
Full name of responsible person
Dr. Siavash Falahatkar
Street address
Razi hospital
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre
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
Urology Research Center
Full name of responsible person
Dr. Neda Ebrahimpour
Position
MD /Resident
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
Email
urc1384@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Hossein Khoshrang
Position
Assistant Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
Email
hkhoshrang@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Bachlor/ Accountant of Urology Research Center
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
www.urc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)