Our purpose of this study is to compare the efficacy, safety and side effects of intranasal midazolam and oral chloride hydrate in the sedation of children with head trauma in order to perform imaging, in order to provide a safe and appropriate way of doing this.
In this study, children with head trauma referring to the emergency department who require CT scan of the head are divided into two groups using randomized blocking method.Intranasal midazolam at a dose of 0.3 mg/ kg or syrup of chloral hydrate at a dose of 75 mg/ kg are used for children sedation.Ramsay sedation scale was used for assessment of sedation level.A score of four are considered as adequately sedated.If it does not reach this level after 20 minutes, one third of the dose of the initial drug is repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Alert children 1-8 years with head trauma require a CT scan that does not have the necessary co-operation to do it.
Exclusion criteria:nasal allergy; known contraindications to the
use of study drugs and receiving a sedative hypnotic agent within the past 48 hours.
Intervention groups
The intervention group receives a single dose of intranasal midazolam 0.3 mg / kg and oral syrup.
The control group receives oral chloral hydrate and intranasal placebo.
Main outcome variables
The main outcome of the study is the efficacy and safety of Intranasal Midazolam and the success in performing CT scan.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N4
Registration date:2018-04-11, 1397/01/22
Registration timing:registered_while_recruiting
Last update:2018-04-11, 1397/01/22
Update count:0
Registration date
2018-04-11, 1397/01/22
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sedative Effect of Intranasal Midazolam Spray and Chloral Hydrate in Children with Head Trauma for Imaging in Emergency Department
Public title
Evaluation of the effect of oral chloral hydrate and intranasal midazolam on sedation of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The child is alert with head trauma requires CT scan of head
Lack of cooperation for CT scan
American Society ofAnesthesiology (ASA) class 1 or 2
Exclusion criteria:
Receiving a sedative hypnotic agent within thepast 48 hours
Gastritis
Serious systemic disease
Nasal allergy to drugs
Obesity (body mass index.30)
Known contraindications to theuse of study drugs (eg, hypersensitivity),
Age
From 1 year old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs were packed by the pharmacist. Each packet contained a nasal spray and syrup.The packets were named A and B following the codes. In one packet,there are intranasal Midazolam and oral placenta, and in another packet, there are an equal volume of chloral hydrate syrup and the intranasal placebo.Patients are randomized to receive one of the packets.The patients and their parents and the nurses are unaware of the contents of the drugs.Data collectors, outcome assessors and data analysts are all kept blinded to the allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Alzahra hospital,Sofe Ave., Shahid Keshvari Blvd.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUI.RES.1396.3.516
Health conditions studied
1
Description of health condition studied
Head trauma
ICD-10 code
S00
ICD-10 code description
Superficial injury of head
Primary outcomes
1
Description
Sedation level of the patient. A score of four is considered
Timepoint
Every 5 minutes
Method of measurement
Physical exam
2
Description
Success in CT scan doing
Timepoint
After refer to the radiology department
Method of measurement
Performing or not performing a CT scan
Secondary outcomes
1
Description
Side effects
Timepoint
every 5 minutes
Method of measurement
Physical exam
2
Description
Vital signs (blood oxygen saturation level, pulse rate and respiratory rate per minute)
Timepoint
Every 5 minutes
Method of measurement
Physical exam
3
Description
The time interval from taking the drugs to the adequate sedation
Timepoint
Every 5 minutes
Method of measurement
Ramsay sedation scale
4
Description
The interval time between drug taking and CT scan performing
Timepoint
Every 5 minutes
Method of measurement
Record time
5
Description
The time interval from taking the drug to the child's full consciousness
Timepoint
Every 5 minutes
Method of measurement
Record time
6
Description
The parents' satisfaction
Timepoint
After the child's consciousness
Method of measurement
Question from parents
Intervention groups
1
Description
Control group: Syrup chloral hydrate 75 mg / kg and placebo intranasal
Category
Treatment - Drugs
2
Description
Intervention group: Intranasal midazolam 0.3 mg / kg and oral placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra and Kashani hospital
Full name of responsible person
Farhad Heydari
Street address
Alzahra Hospital,Sofeh Ave.,Shahid Keshvari Blvd
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh haghjooy javanmard
Street address
Alzahra Hospital,Sofeh Ave.,Shahid Keshvari Blvd.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com
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
10
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
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available