Determination of the effect of oral diphenhydramine and midazolam on sedation (sedation) of children referred to emergency department of Bahonar hospital in Kerman
Design
Clinical trial with control group, with parallel groups, without blindness, randomized with sample size 74, of both genders
Settings and conduct
This clinical trial study was performed on 74 children aged 1 to 7 years old in Bahonar Kerman hospital for diagnostic procedures. The method of this study was to determine that the first patient referring to the randomly randomized randomized (randomized) The groups were assigned and the next patients were selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Children aged 1 to 7 years with mild moderate levels of consciousness
Exclusion criteria:1-Parental dissatisfaction 2- GCS ≤8
3-Unstable hemodynamics
Intervention groups
To the first group, midazolam was administered at a dose of 0.5 mg / kg
The second group received diphenhydramine at a dose of 0.5 mg / kg
Main outcome variables
Relaxation rate of children referred to the hospital for diagnostic use with oral diphenhydramine and midazolam.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190613043882N1
Registration date:2019-07-08, 1398/04/17
Registration timing:retrospective
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
neda naeimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3226 4071
Email address
s.ghasemirad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-20, 1397/10/30
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
2019-01-20, 1397/10/30
Actual recruitment end date
2019-04-20, 1398/01/31
Trial completion date
2019-04-20, 1398/01/31
Scientific title
Comparison of the effect of Diphenhydramine and oral midazolam sedation on children admitted toEmergency department of Kerman’s Bahonar Hospital
Public title
Comparison of the effect of oral diphenhydramine and midazolam on the sedation of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Child 1 to 7 years old
With a mild to moderate level of consciousness
Exclusion criteria:
Parental dissatisfaction
GCS≤83
Absence of hemodynamic stable
Age
From 1 year old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Actual sample size reached:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are available by sampling method and were selected using a simple accident method with a random number table.74 blocks including 37 patients in the diphenhydramine group and 37 patients in the midazolam group.30 minutes before starting diagnostic procedure (CT, radiology and sonography), children were given oral metidazolam and oral diphenhydramine.Individual randomization unit and there is no layered randomization.There was no cloak. Analysis was performed using statistical software.
Blinding (investigator's opinion)
Not 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 Kerman University of Medical Sciences
Street address
Ebn-e-Sina St.,Jahad Blvd.,Kerman,Iran
City
kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-03-10, 1397/12/19
Ethics committee reference number
IR.KMU.REC.1397.520
Health conditions studied
1
Description of health condition studied
The effect of sedation of diphenhydramine and midazolam on children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average relaxation of diphenhydramine
Timepoint
30 minutes before starting radiologic diagnostic procedure
Method of measurement
Recovery Scoring Systems
2
Description
Average relaxation of midazolam
Timepoint
30 minutes before starting radiologic diagnostic procedure
Method of measurement
Recovery Scoring Systems
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, 30 minutes before the start of the diagnostic radiology protocol (CT, radiology and sonography), children were given oral midazolam from the Caspian Pharmaceutical Company at a dose of 0.5 mg / kg.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, 30 minutes before the initiation of diagnostic radiology (CT, radiology and sonography), diphenhydramine children were prescribed from the Emad darman Pars Pharmaceuticals Company at a dose of 0.5 mg / kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Bahonar hospital in Kerman
Full name of responsible person
Sareh GHasemirad
Street address
Ebn-e-Sina St.,Jahad Blv.,Kerman.,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
s.ghasemirad@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sareh Ghasemirad
Street address
Ebn-e-Sina St.,Jahad Blv.,Kerman.,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Fax
Email
s.ghasemirad@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
1
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
Kerman University of Medical Sciences
Full name of responsible person
Neda Neimi
Position
Clinical Assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Ebn-e-Sina St.,Jahad Blv.,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
behnazkarimpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Neda Neimi
Position
Clinical Assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Ebn-e-Sina St.,Jahad Blv.,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
behnazkarimpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Neda Naeimi
Position
Clinical Assistant
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Research Deputy.E-bn Sina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4071
Fax
Email
s.ghasemirad@kmu.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