Comparison of clinical efficacy of Intranasal administration of midazolam and ketamine in managing pain and distress associated with peripheral IV access in children presenting to emergency departments of IUMS
The aim of this study is to evaluate the clinical efficacy and analgesic and sedative effects of intranasal administration of Ketamine And Midazolam in peripheral IV access in children presenting to the emergency department.
Design
Two arm parallel open-label randomized controlled trial of 100 children ; No control group; randomization with RRApp software
Settings and conduct
Children presenting to the emergency department of hospitals of Iran University of Medical Sciences are divided into two groups. Midazolam or ketamine is administered intranasally before the procedure. Heart rate and blood oxygen percentage are recorded by a portable pulse oximeter, pain, and sedation by the Observational Scale Of Behavioral distress-Revised (OSBD-R) and possible complications, procedure success, parents and nurses satisfaction through observation and checklist
Participants/Inclusion and exclusion criteria
Inclusion Criteria: all the children aged one to 10 years old, who need hospitalization and peripheral IV access for diagnostic and therapeutic measures
Exclusion criteria: level 1 triage, parental dissatisfaction, history of drug allergies, severe underlying diseases
Intervention groups
Intranasal administration of ketamine (5 mg/kg) or midazolam (0.2 mg/kg) with the use of a syringe, before accessing IV line
Main outcome variables
OSBD-R score in two group
Success rate of peripheral IV Access;
Heart rate and blood oxygen Saturation;
Satisfaction of parents and nurses;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048242N1
Registration date:2020-08-10, 1399/05/20
Registration timing:retrospective
Last update:2020-08-10, 1399/05/20
Update count:0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Iman Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5422 1337
Email address
jafarnejad.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-07-19, 1398/04/28
Actual recruitment end date
2020-05-12, 1399/02/23
Trial completion date
2020-05-12, 1399/02/23
Scientific title
Comparison of clinical efficacy of Intranasal administration of midazolam and ketamine in managing pain and distress associated with peripheral IV access in children presenting to emergency departments of IUMS
Public title
Comparison of intranasal midazolam and ketamine in peripheral IV access in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1 to 10 years-old Children
Emergency department or wards admission
Needing IV access for diagnostic and therapeutic interventions
Exclusion criteria:
Patients with critical or emergency conditions, or in other words, have level 1 triage and are treated in the resuscitation room
All cases in which parents do not consent to sedation and analgesia prior to peripheral intravenous access
All patients with a history of allergies to ketamine or midazolam
Age less than one year or over 10 years
Existence of serious underlying heart disease including heart failure, electrical heart disorders, congenital heart defects
Presence of advanced liver or kidney disease, including renal failure or dialysis, history of kidney or liver transplantation, congenital metabolic disorders
Children with cerebral palsy, cystic fibrosis and epilepsy
Congenital or acquired jaw and facial abnormalities
Age
From 1 year old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The type of drug prescribed is randomized by simple randomization among the participants by using the RRApp software.
For this purpose, in the order of participation in the research, the participants will receive midazolam or ketamine based on the group they are assigned by RRApp software.
Allocation concealment is not carried out.
http://clinicalresearch-apps.com/RRApp.html
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
Iran University of Medical Sciences Research Ethics Committee
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, fifth floor of the headquarters
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.IUMS.FMD.REC.1398.143
Health conditions studied
1
Description of health condition studied
Pain and distress associated with peripheral IV access in children in emergency department
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Observational Scale Of Behavioral distress-Revised Score
Timepoint
20 min after intervention
Method of measurement
Observational Scale Of Behavioral distress-Revised (OSBD-R)
2
Description
Success rate of accessing peripheral Intravenous line
Timepoint
20 min after the intervention
Method of measurement
Researcher observation based on the presence or lack of physical restraint during the procedure
Secondary outcomes
1
Description
Heart Rate
Timepoint
10 and 20 minutes after the intervention
Method of measurement
Portable Pulse Oximeter
2
Description
Oxygen Saturation
Timepoint
10 and 20 minutes after the intervention
Method of measurement
Portable Pulse Oximeter
3
Description
Satisfaction of parents
Timepoint
Once after the end of the procedure
Method of measurement
5 point likert scale
4
Description
Satisfaction of nurses
Timepoint
Once after the end of the procedure
Method of measurement
5 point likert scale
Intervention groups
1
Description
Intervention group 1: Intranasal ketamine administration, at a dose of 5 mg/kg from a 50 mg/cc ketamine ampule, produced by Rotexmedica, Germany, twenty minutes before peripheral intravenous access, once via intranasal route, at half the dose in each nostril with a conventional syringe
Category
Other
2
Description
Intervention group 2: Intranasal midazolam administration, at a dose of 0.2 mg/kg from a 5 mg/cc midazolam ampule, produced by Darou Paksh pharmaceutical company, twenty minutes before peripheral intravenous access, once via intranasal route, at half the dose in each nostril with a conventional syringe
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, fifth floor of the headquarters
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Web page address
http://www.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Iman Mehrabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
ShahrAra, Arash Mehr st., West Blvd., No 24, Unit 9
City
Tehran
Province
Tehran
Postal code
1444953541
Phone
+98 11 5422 1337
Fax
Email
Imannnehrabi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iman Mehrabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
ShahrAra, Arash Mehr st., West Blvd., No 24, Unit 9
City
Tehran
Province
Tehran
Postal code
1444953541
Phone
+98 11 5422 1337
Fax
Email
Imannnehrabi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iman Mehrabi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
ShahrAra, Arash Mehr st., West Blvd., No 24, Unit 9
City
Tehran
Province
Tehran
Postal code
1444953541
Phone
+98 11 5422 1337
Fax
Email
Imannnehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information related to the study protocol, OSBD-R score including four steps, statistics related to the success of the procedure, statistical information and tables and graphs, informed consent form, satisfaction of parents and nurses, information related to heart rate and blood oxygen percentage.
When the data will become available and for how long
Starting one year after publication
To whom data/document is available
To anyone whom may benefit from reviewing the information provided, in regard to progressing scientific knowledge
Under which criteria data/document could be used
The use of data by mentioning the source, in case of advancement of scientific knowledge, is unrestricted
From where data/document is obtainable
Contact the email address regarding data acquisition:
imannnehrabi@gmail.com
Iman Mehrabi, MD.
What processes are involved for a request to access data/document
Send an email stating the reason for the need to access the information