The aim of the study is to determine the effect of ketamine intranasal with placebo in ease of access to peripheral veins and reduce child pain
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. The sample size for each study group is 40.
Settings and conduct
The main aim of the study is the success venipuncture of the pediatric ward of children referred to the Emergency Department of Ali Asghar Hospital, Iran University of Medical Sciences in 2018. participants and physicians assess clinical conditions of patients will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children aged 6 months to 6 years in an emergency needing to venipuncture. Exclusion criteria: Unwell children; Intense dehydration; having a history of allergy to ketamine; seizure; having brain lesions; increased intracranial pressure.
Intervention groups
Before doing venipuncture, ketamine will be given intranasal with a dose of 4 miligeram per Kilograms body weight and According to the half-life and the maximum effect time of the drug will be taken venipuncture 5 minutes later.
Main outcome variables
Success in venipuncture; duration of start venipuncture unitl the end; pain patient.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120613010017N7
Registration date:2018-06-17, 1397/03/27
Registration timing:registered_while_recruiting
Last update:2018-06-17, 1397/03/27
Update count:0
Registration date
2018-06-17, 1397/03/27
Registrant information
Name
Hamed Basir Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9233
Email address
h-basirghafouri@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-24, 1397/02/04
Expected recruitment end date
2018-11-25, 1397/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ketamine intranasal with placebo in ease of access to peripheral veins and reduce child pain
Public title
Effect of ketamine intranasal in ease of access to peripheral veins
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 months to 6 years in an emergency needing to venipuncture
Exclusion criteria:
Unwell children
Intense Dehydration
Having a history of allergy to ketamine
Seizure
Having brain lesions
Increased intracranial pressure
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups using a block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study will be blinded of the type of received intervention. Physicians assessing the clinical conditions of participants will be blinded of the type of intervention received by patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9511307006
Health conditions studied
1
Description of health condition studied
Easy venipuncture in all children that venipuncture is needed in the process of treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Success in venipuncture
Timepoint
Count the insert needle
Method of measurement
Count
2
Description
Duration in successful venipuncture
Timepoint
Duration from start to end of successful venipuncture
Method of measurement
Observe
Secondary outcomes
1
Description
Patient pain
Timepoint
End of venipuncture
Method of measurement
Using Visual Analogue Scale for pain measurement
Intervention groups
1
Description
Intervention group: Before doing venipuncture, intranasal ketamine will be given with a dose of 4 miligeram per Kilograms body weight and according to the half-life and the maximum effect time of the drug will be taken venipuncture 5 minutes later.
Category
Treatment - Drugs
2
Description
Control group: Intranasal Normal Saline will be prescribed in the form of spray before venipuncture doing. After 5 minutes venipuncture will be taken.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Hamed Basir Ghafouri
Street address
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Email
Basirghafoori.h@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Email
Basirghafoori.h@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
Hamed Basir Ghafouri
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Email
Basirghafoori.h@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamed Basir Ghafouri
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Email
Basirghafoori.h@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamed Basir Ghafouri
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Rasoul Akram hospital, Niyayesh St, Sattar Khan St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6653 9233
Email
Basirghafoori.h@iums.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