Objective: To compare the effect of intranasal midazolam versus different doses of intranasal ketamine in reducing preoperative pediatric anxiety. Methodology: The participants of this double blind clinical trial study consisted of 120 children. Their age range was between 2-8 years. They were in ASA class I of anesthesia and were chosen for elective surgery in Qods hospital in Qazvin, Iran. The patients were randomly divided in four equal groups. Intervention: For reducing patients' anxiety, in the first group midazolam 0.2mg/kg, in the second group ketamine 0.5 mg/kg, in the third group ketamine 3 mg/kg and in the fourth one normal saline 1drop/kg were administered intranasally. Fifteen minutes after drug administration, severity of anxiety had been assessed with modified Yale preoperative anxiety score (m-Yale PAS) and level of sedation had been evaluated by Ramsay sedation scale in operative room before intravenous catheterization. All data were transferred to the SPSS-10 software and analyzed statistically with Anova, Kroscal Valis and Mann-Whitney tests. P-Value less than 0.05 was considered meaningful. Primary outcome measure: Anxiety Primary outcome time point : Fifteen minutes after drug usage(before IV line insertion) Primary outcome method of measurement: M-Yale PAS chart and Ramsay Sedation Scale chart Inclusion: Elective surgery ;ASA class1 ;Age between 2-8 years exclusion criteria :ASA class 2or higher ;Childs using antihistaminic, anticonvulsive, analgesic or sedative agents ;Childs with nasopharyngeal dysfunction, upper respiratory tract infection, epistaxis or allergic rhinitis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104236254N1
Registration date:2011-09-07, 1390/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-07, 1390/06/16
Registrant information
Name
Nematolah Adeli
Name of organization / entity
Qazvin , University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 7006
Email address
neadeli@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice -chancellor for research, Qazvin university of medical sciences
Expected recruitment start date
2010-05-23, 1389/03/02
Expected recruitment end date
2010-08-27, 1389/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intranasal midazolam versus different doses of intranasal ketamine in reducing preoperative pediatric anxiety
Public title
Comparison the effect of intranasal midazolam versus different doses of intranasal ketamine in reducing preoperative pediatric anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Elective surgery ;ASA class 1; Age between 2-8 years Exclusion criteria : ASA class 2 or higher ;Children using antihistaminic, anticonvulsive ,analgesic or sedative agents ;Children with nasopharyngeal disorder, upper respiratory tract infection ,epistaxis or allergic rhinitis.
Age
From 2 years old to 8 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Qazvin university of medical sciences
Street address
Shahid Bahonar, Blvd
City
Qazvin
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
4262/20/28
Health conditions studied
1
Description of health condition studied
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of childhood
Primary outcomes
1
Description
Anxiety
Timepoint
Fftheen minutes after drug usage(before IV line insertion)
Method of measurement
M-Yale PAS
Secondary outcomes
empty
Intervention groups
1
Description
Control : Group3 received 1 drop/kg normal salin
Category
Prevention
2
Description
Intervention: patients in group one received0.2 mg/kg midazolam
Category
Prevention
3
Description
Intervention: group 2 received0.5 mg/kg ketamine
Category
Prevention
4
Description
Intervention: group 4received3 mg/kg ketamine
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghods Hospital
Full name of responsible person
Dr Nematollah Adeli
Street address
Plate 20 , Ghods Blvd , Qazvin City
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Qazvin University of Medical Science
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Post code431102589 , Plate 3, Shahid Bahonar Blvd , Qazvin City
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research of Qazvin University of Medical Science
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
Qazvin, University of Medical Science and health services
Full name of responsible person
Nematollah Adeli
Position
Resident
Other areas of specialty/work
Street address
Post Code 4321102589 , Plate 3 , Shahid Bahonar Blvd , Qazvin City
City
Qazvin
Postal code
4321102589
Phone
+98 28 1223 6381
Fax
Email
neadeli@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin, University of Medical Sciences and Health Services
Full name of responsible person
Seyed Abbas Hosseini Jahromi
Position
Assistant professor in anesthesia
Other areas of specialty/work
Street address
Post code 4321102589 , Plate 3 , Shahid Bahonar Blvd, Qazvin City
City
Qazvin
Postal code
4321102589
Phone
+98 28 1223 6381
Fax
+98 28 1333 7006
Email
papaya812002@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin , University of Medical Sciences and Health Services
Full name of responsible person
Nematollah Adeli
Position
Resident
Other areas of specialty/work
Street address
Postcode 4321102589, Plate 3 , Shahid Bahonar Blvd, Qazvin City
City
Qazvin
Postal code
4321102589
Phone
+98 28 1333 6001
Fax
+98 28 1333 7006
Email
neadeli@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)