Comparison the sedative effect of intranasal midazolam and dexmedetomidine with for sedation of children1 to 6 year-old undergoing Computerized tomography(CT) scan that referred to emergency department of Kashani and Al-zahra hospitals in Isfahan in 2017
Determination and comparison of the sedation efficacy of intranasal injection of midazolam and dexmedetomidine for CT scan imaging in 1-6 years old children referred to emergency department of Kashani and Alzahra hospitals, Isfahan 2017
Design
The present study is a double-blind clinical trial that 162 patients will be randomly divided into two groups (n1=n2=81). The medication will be prepared by a nurse and placed inside the envelope and labeled A and B. Therefore, both patient and therapist are unaware about the type of treatment.
Settings and conduct
This study was conducted on children referring to Kashani and Al-zahra hospitals in Isfahan for CT scan in 2017. In the first group, Midazolam ,and in the second group, it was administered Dexmedetomidine intranasally. the two medications were used by Mucosal Atomization Device, MAD 300 .A double blind study involving patient and physician.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Children's age range , 1 to 6- yearold, requiring diagnostic imaging(CT scan).
2-Parental satisfaction to participate in this study.
Exclusion criteria:
1-Excessive sensitivity to medications fo benzodiazepines family and the alfa-agonist drugs
2-Hemodynamic unstability
3-severe hypotension and shock
4-pulmonary disease
Intervention groups
Our study aimed to compare the sedation effect of intranasal injection of Dexmedetomidine and Midazolam in 1-6 years old children who required for CT scan imaging.
Intervention group: Will receive Dexmedetomidine by intranasal injection.
Control group: Will receive Midazolam by intranasal injection.
Main outcome variables
The beginning of sedation;imaging time(procedure time);blood pressure;pulse rate;blood o2 saturation,recovery time ;side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190509043538N1
Registration date:2019-08-26, 1398/06/04
Registration timing:retrospective
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Ali Bigdeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3292 2172
Email address
alibigdeli52@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Comparison the sedative effect of intranasal midazolam and dexmedetomidine with for sedation of children1 to 6 year-old undergoing Computerized tomography(CT) scan that referred to emergency department of Kashani and Al-zahra hospitals in Isfahan in 2017
Public title
Comparison of the sedative effect of intranasal midazolam and dexmedetomidine for pediatric
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Children's age range from 1 year to 6 years old requires a CT scan.
Parental satisfaction to participate in this study.
Exclusion criteria:
Having excessive sensitivity to benzodiazepines and family members as well as alpha agonists
Alertness level based on the Glasgow Coma Score less than 15
Having very low blood pressure or shock
Having weak and unstable vital signs
Having lung disease
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
162
Actual sample size reached:
143
Randomization (investigator's opinion)
Randomized
Randomization description
The studied samples will be randomly divided into two groups of 81 individuals by selecting envelopes. Each envelope was contained with one of the two labels A or B representing Midazolam or Dexmedetomidine. Children will be in one of two groups .
Blinding (investigator's opinion)
Double blinded
Blinding description
To meet the double blindness of the study, Midazolam ( dose of 0.3 mg /kg) and Dexmedetomidine (dose of 3 mcg /kg) will be prepared daily by the emergency nurse (uninformed) and labeled A or B and also will be available for the researcher daily. The researcher will be prescribed the mentioned medicine by syringe intranasally.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
No.15,Yas building, Sadoughi Ave,Yasaman St,
City
Qom
Province
Isfehan
Postal code
3716937314
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
Ir.mui.rec.1396.2.076
Health conditions studied
1
Description of health condition studied
Head trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Success in sedation intranasally
Timepoint
0,10,20,30 min
Method of measurement
By Ramsay scoring
Secondary outcomes
1
Description
Measurement of blood pressure ; pulse rate; blood oxygen saturation;
Timepoint
0;10;20;30 minutes
Method of measurement
PulseOxymetery;Sphygmomanometer
Intervention groups
1
Description
Intervention group: The intervention group will have received Dexmedetomidine (manufactured by Hospira Co. USA) interanasally. The agent will be prepared daily by a nurse and will prescribed by Intranasal Mucosal Atomization Device (IMAD), that called MAD Nasal 300 (manufactured by Teleflex Medical Co, USA) by dose 3 μg/kg. Up to 1 ml of the medication will be injected in each nostril of nose by a 2 cc syringe (G 22, manufactured by Avapezeshk Co, Iran). The injection of medication is carried out when the patient is being supine position and in resting. Two minutes after injection of medication into the nostrils, the patient can place in sitting position.
Category
Treatment - Drugs
2
Description
Control group: The control group will have received Midazolam (manufactured by Exir Co, Iran) interanasally. The agent will be prepared daily by a nurse and will prescribed by Intranasal Mucosal Atomization Device (IMAD), that called MAD Nasal 300 (manufactured by Teleflex Medical Co, USA) by dose 0.3 μg/kg. Up to 1 ml of the medication will be injected in each nostril of nose by a 2 cc syringe (G 22, manufactured by Avapezeshk Co, Iran). The injection of medication is carried out when the patient is being supine position and in resting. Two minutes after injection of medication into the nostrils, the patient can place in sitting position.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital,Al-Zahra hospital
Full name of responsible person
Ali Bigdeli
Street address
No.15, Yas building,Yasaman St,Sadoughi Ave.
City
Qom
Province
Ghoum
Postal code
3716937314
Phone
+98 25 3292 2172
Email
alibigdeli52@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azizkhani ,Reza
Street address
Sufeh Blvd, Al Zahra Hospital, Department of Emergency Medicine
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
idem@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azizkhani ,Reza
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sufeh Blvd, Al Zahra Hospital, Department of Emergency Medicine
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
r_azizkhani@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azizkhani ,Reza
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Sufeh Blvd, Al Zahra Hospital, Department of Emergency Medicine
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
r_azizkhani@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Bigdeli
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
No. 15,Yas building, Yasaman St. Sadooghi Ave.
City
Qom
Province
Ghoum
Postal code
3716937314
Phone
+98 25 3292 2172
Fax
Email
alibigdeli52@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available