Comparison of the Effect of EMLA Cream on Intravenous Cannulation Pain of 2-6 years Old Children : Comparison of Application between 20 and 60 Minutes before Cannulation with control group.
The purpose of the study:Comparison of the Effect of EMLA Cream on Intravenous Cannulation Pain of 2-6 years Old Children : Comparison of Application between 20 and 60 Minutes before Cannulation.
Study Design:Double-blind randomized clinical trial
The inclusion criteria : children 6-2 years old admitted for elective small surgery ,who are conscious and calm or be able to calm down with the usual ways .
The exclusion criteria : restless children , the children with loss of consciousness , children receive sedative or analgesic and children with a history of sensitivity to lidocaine.
Intervention: reduce close dressing time with EMLA cream ( from 60 to 20 minutes)
Time of intervention: before Intravenous Cannulation
Primary outcome of study: savings in time and the possibility of using EMLA crem in emergency.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051822309N1
Registration date:2015-12-11, 1394/09/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Behzad Aliakbari Sharabiani
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1994
Email address
aliakbarib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
supplied by the researcher.
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2015-06-10, 1394/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of EMLA Cream on Intravenous Cannulation Pain of 2-6 years Old Children : Comparison of Application between 20 and 60 Minutes before Cannulation with control group.
Public title
Comparison of the Effect of EMLA Cream on Intravenous Cannulation Pain of 2-6 years Old Children : Comparison of Application between 20 and 60 Minutes before Cannulation.
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria : children 6-2 years old admitted for elective small surgery ,who are conscious and calm or be able to calm down with the usual ways .
The exclusion criteria : restless children , the children with loss of consciousness , children receive sedative or analgesic and children with a history of sensitivity to lidocaine.
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
231
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht st., University of Medical Sciences,Faculty of Medicine
City
Tabriz
Postal code
Approval date
2015-01-12, 1393/10/22
Ethics committee reference number
93150
Health conditions studied
1
Description of health condition studied
Local Anesthesia
ICD-10 code
R20.0
ICD-10 code description
Anaesthesia of skin
Primary outcomes
1
Description
pain severity
Timepoint
20 and 60 minute after intervention
Method of measurement
based on FLACC Behaviorral Tool table
Secondary outcomes
1
Description
time to onset of drug action
Timepoint
20 and 60 minute
Method of measurement
with timer
Intervention groups
1
Description
Group 1: EMLA cream, with 2cm lenght and 0.5cm diameter (0.5 gr) in occlusive dressing, 20 minute before cannulation
Category
Treatment - Drugs
2
Description
Group 2: EMLA cream, with 2cm lenght and 0.5cm diameter (0.5 gr) in occlusive dressing, 60 minute before cannulation.
Category
Treatment - Drugs
3
Description
Group 3(control):Vitamin A+D cream, with 2cm lenght and 0.5cm diameter in occlusive dressing,60 minute before cannulation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Behzad Aliakbari Sharabiani
Street address
Sheshgilan street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
We do not have financial support
Full name of responsible person
Behzad Aliakbari Sharabiani
Street address
OR, Pediatric Hospital, Sheshgilan street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
We do not have financial support
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Medical University -Faculty of Medicine
Full name of responsible person
Hossein Razmi Dizaj
Position
Medical Student
Other areas of specialty/work
Street address
Sheshgilan - Children Hospital-
City
Tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 35262250
Email
Razmihossein1989@gmail.com
Web page address
http://childrenhospital.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of medicine - Faculty of Medicine
Full name of responsible person
Behzad Aliakbari Sharabiani
Position
anesthesiologist - Assistant Professor
Other areas of specialty/work
Street address
Sheshgilan- Chldren Hospital
City
Tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 35262279
Email
sharabiani48@gmail.com
Web page address
http://childrenhospital.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
University of Medicine - Faculty of Medicine
Full name of responsible person
Hossein Razmi Dizaj
Position
Medical Student
Other areas of specialty/work
Street address
Children Hospital
City
Tabriz
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 35262279
Email
Razmihossein1989@gmail.com
Web page address
http://childrenhospital.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)