A comparison of the sedative effect of oral Midazolam versus nazal Ketamine combined with Nitrous Oxide in pediatric EUA
Design
A clinical trial with a control group, with parallel groups, three-way
Blinded, randomized, phase 2 on 30 patients. for randomization Excel software was used.
Settings and conduct
This is a three-blind randomized clinical trial on
30 candidate patients will undergo eye evaluation in Faiz operating room at Isfahan city ; After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients will be randomly assigned into 2 groups, in each group the intended intervention is applied and the patient's clinical symptoms are recorded .which records the patient's symptoms, the analyzers which collect the data in they analyze the length of the study and also inform the patients about the type of intervention It has not been applied in any group and therefore they are all blind.
Participants/Inclusion and exclusion criteria
Entry requirements: Candidate patients for eye evaluation in Eye Faiz operating room, age between 2 to 6 years, informed consent of the child's family to participate in the study
Exclusion criteria: lack of informed consent of the family during the study, complications due to drug use
Intervention groups
In the intervention group A: 10 minutes before anesthesia, patients receive mg/kg of ketamine intranasally at the same time as nitrous oxide gas administration.
In intervention group B:patients receive mcg/kg of oral midazolam
At the same time as nitrous oxide gas administration
Main outcome variables
SP02, PR, Recovery time, Sedation score based on the Ramsey sedation scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N51
Registration date:2023-06-02, 1402/03/12
Registration timing:prospective
Last update:2023-06-02, 1402/03/12
Update count:0
Registration date
2023-06-02, 1402/03/12
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the sedative effect of oral Midazolam versus nazal Ketamine combined with Nitrous Oxide in pediatric EUA
Public title
Check the effect of ketamine and Midazolam in EUD
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children candidates for eye evaluation under anesthesia(EUA)
Age between 2 and 6 years
Informed consent of the child's family to participate in the study
Exclusion criteria:
Lack of informed consent of the family during the study
Complications caused by drug use
Age
From 2 years old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by the simple method in which each patient will be assigned a code using a random number table (Random allocation software) and Patients fall into one of two groups depending on whether these codes are even or odd. This continues until the number of patients in both groups reaches the required number.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a three-way blind clinical trial; in such a way that
The clinical caregiver who is responsible for the care and treatment of the participant in the study is blinded. The analysts who analyze the data collected during the study are also blinded.
They do not know the type of intervention applied in each group and are blind.
Even though the guardians of the patients are included in the study, they do not know about it
They do not have the type of intervention applied and are blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Hezar jerib
City
Esfanah
Province
Isfehan
Postal code
8174673461
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.MUI.MED.REC.1401.431
Health conditions studied
1
Description of health condition studied
Examination UnderAnaesthetic (EUA)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of sedation
Timepoint
Every 5 minutes
Method of measurement
Visual Analogue Scale
2
Description
Blood oxygen saturation
Timepoint
Every 5 minutes
Method of measurement
Pulse oximetry
3
Description
Pulse Rate
Timepoint
Every 5 minutes
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, one milligram of midazolam is given through the nose and prescribed only once
Category
Treatment - Drugs
2
Description
Intervention group: The second group of ketamine is given 0.5 mg/kg through the nose and it is prescribed only once .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fiez Hospital
Full name of responsible person
Behzad Nazemoaya
Street address
Hezar Jerib
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 13 0263 0202
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayegh Haghjoo
Street address
Hezar Jerib
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 13 8663 8400
Email
research@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
Mohamad Mahdi Haidar
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jerib
City
esfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 13 0263 0202
Email
mohamadhaidar93333@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate Professor of Anesthesiology and Critical Care, Isfahan Medical School
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
HezarJerib
City
Esfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 13 0263 0202
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jerib
City
Esfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 13 0263 0202
Email
behzad_nazem@med.mui.ac.ir
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
Undecided - It is not yet known if there will be 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available