Protocol summary

Summary
Children -parents dissociation and enterance to the operating room are accompanied with anxiety which causes unwished intra and postoperative complications.Postoperative agitation, pain, nausea and vomiting are other problems that reducing and controlling them, is one of the aims of an anesthesiologist.The purpose of this study is to compare the effect of intranasal dexmedetomidine, midazolam and ketamine on preoperative sedation and postoperative nausea, vomiting and pain and as a result, decreasing the hospital cost, shorter recovery stay and early return of children to daily activity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013081614372N1
Registration date: 2014-02-11, 1392/11/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-11, 1392/11/22
Registrant information
Name
Simin Azemati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4270
Email address
azemati@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences,vice chancellor of research
Expected recruitment start date
2013-07-23, 1392/05/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of sedative effect of intranasal Dexmedetomidine,Midazolam and Ketamine in outpatient pediatric surgeries
Public title
comparison of sedative effect of Dexmedetomidine,Midazolam and Ketamine in outpatient pediatric surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: children aged between 2-7 year; ASA classification I-II; unilateral inguinal herniorraphy Exclusion criteria: Hx. of hypersensitivity to drugs of the study(Midazolam; Ketamine and Dexmedetomidine); liver failure; renal failure; upper respiratory tract infection; cardiac arrythmia; congenital heart disease; neurologic disease
Age
From 2 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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 Shiraz University of Medical Sciences
Street address
Vice Chancellor for research ; Shiraz University of Medical Sciences ,Zand street
City
SHIRAZ
Postal code
Approval date
2013-09-15, 1392/06/24
Ethics committee reference number
CT-P-92-5311

Health conditions studied

1

Description of health condition studied
Restlessness and agitation
ICD-10 code
R45
ICD-10 code description
Symptoms and signs involving emotional state

Primary outcomes

1

Description
anxiety
Timepoint
Every 10 min after seperation of parents
Method of measurement
Observation( Four point scale)

2

Description
Pain
Timepoint
Every 15min in PACU
Method of measurement
Observation( Modified objective pain scale)

3

Description
Nausea &vomiting
Timepoint
Recovery time
Method of measurement
observation

4

Description
Sedation
Timepoint
Every 10 minutes
Method of measurement
Obsevation( Modified observer's assessment alertness sedation)

Secondary outcomes

1

Description
Sedation scale in PACU
Timepoint
Every 15 min
Method of measurement
Observation( Modified observer's assessment alertness sedation)

Intervention groups

1

Description
intra nasal midazolam 0.2 mg/kg ,45-60 minutes before induction
Category
Treatment - Drugs

2

Description
Intranasal ketamine 8mg/kg ,45-60 minutes before induction
Category
Treatment - Drugs

3

Description
Intranasal dexmedetomidine 1.5 mic /kg ,45-60 minutes before induction
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nemazi hospital
Full name of responsible person
Maryam Keihani
Street address
Zand street
City
Shiraz

2

Recruitment center
Name of recruitment center
Ghadir hospital
Full name of responsible person
Maryam Keihani
Street address
Koran Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences. Research chancellor
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
Research chancellor, Shiraz University of Medical Sciences. Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences. Research chancellor
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
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Keihani
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Anesthesia department, Shahid Faghihi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1231 8072
Fax
Email
keihani@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of anesthesia, Shiraz anesthesiology and critical care research center,Shiraz University
Full name of responsible person
Simin azemati
Position
Associate professor of anesthesiology
Other areas of specialty/work
Street address
Anesthesia department, Nemazi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 1647 4270
Fax
Email
azemati@sums.ac.ir azamatis@yahoo.com ,mbkhosravi44@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Medical Faculty
Full name of responsible person
Maryam Keihani
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Anesthesia department, Nemazi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1647 4270
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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