Comparison of the effecacy of EMLA anesthetic cream , 2% lidocaine gel and ice bag on the severity of pain caused by venipuncture in 6-12 hospitalized children Department of Pediatrics, Alhadi Shoushtar Hospital in 2018
Determination of the effect of EMLA anesthetic cream, 2% lidocaine gel and ice bag on severity of pain caused by angioedema in 6-12 years old children admitted to the pediatric ward of al-Hadi hospital in 2018
Design
This is a clinical study. The population studied in this study is children 12-6 admitted to the children's ward of Khatam al-Nabiya Hospital in Shoushtar city in 2018. 160 children were randomly selected using randomly selected random access criteria and blocks were randomly selected using four blocks, so that the block of 2 people will be placed in each intervention group. And will be divided into 4 groups of 40 people. The first group (using spelling anesthetic cream), the second group (using lidocaine gel 2%), the third group (using the ice bag) and the fourth group (control).
Settings and conduct
Khatam Al Anbia Hospital in Shoushtar
Participants/Inclusion and exclusion criteria
The criteria for entering the study included (alertness of the child, lack of urgent need for placenta, first incubation, lack of susceptibility to spelling cream (lidocaine and perilocaine), and absence of any skin disease.
Exit criteria also included children who had Constipated, have taken a sedative with an effective medication, or have verbal, mental, vision, hearing and mental disorders.
Intervention groups
Includes 4 groups of 40 people: the first group (using spelling anesthetic cream), the second group (using lidocaine gel 2%), the third group (using the ice bag) and the fourth group (control).
Main outcome variables
Studying the pain of children during sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121229011923N5
Registration date:2019-01-23, 1397/11/03
Registration timing:registered_while_recruiting
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Akram Hematipour
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8302
Email address
hematipour.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effecacy of EMLA anesthetic cream , 2% lidocaine gel and ice bag on the severity of pain caused by venipuncture in 6-12 hospitalized children Department of Pediatrics, Alhadi Shoushtar Hospital in 2018
Public title
Comparison of the effecacy of EMLA anesthetic cream , 2% lidocaine gel and ice bag on the severity of pain caused by venipuncture in 6-12 hospitalized children Department of Pediatrics, Alhadi Shoushtar Hospital in 2018
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being alert to the child
Not having an urgent need to get pregnant
Lack of susceptibility to spelling cream (lidocaine and perlocaine)
The absence of any skin disease
Exclusion criteria:
Children who have already been pregnant
Have taken a sedative or pain medication
Have verbal, mental, vision, hearing and mental disorders.
Age
From 6 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
160 children were randomly selected using randomly selected random access criteria and blocks were randomly selected using four blocks, so that the block of 2 people will be placed in each intervention group. And will be divided into 4 groups of 40 people. The first group (using spelling anesthetic cream), the second group (using lidocaine gel 2%), the third group (using the ice bag) and the fourth group (control).
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 Ahvaz Jundishapur University
Street address
Golestan Avenue, Esfand Alley
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.AJUMS.REC.1397.618
Health conditions studied
1
Description of health condition studied
Evaluation of pain in children during sedation
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Evaluation of pain in children during IV line with Angiocate
Timepoint
Sampling will take place within 3 months
Method of measurement
In order to determine the severity of pain, a numerical scale of pain (NAS) and a behavioral pain scale (FLACC) will be used.The range of Numerical Scale (NAS) is from 0 to 10, where zero indicates no pain and a score of 5 indicates moderate pain and 10 indicates the highest pain rate. After explaining about the scoring and 5 minutes after the abdomen, the child is asked to measure his pain according to the numerical scale of the pain.Another tool is the use of the Behavioral Scale of Pain (FLACC), which includes five criteria for child behavior such as facial expression, foot movements, activity level, crying and relief, which is well known by nurses who are fully aware of the pain instrument. The behavior of the child is scored during the injection of this questionnaire.So the zero score for the least pain and the two score for the most pain in each criterion is considered. The score of each section is inserted separately and then the 5 sections are combined together to calculate the total pain behavior. The zero score range is the lowest and the 10 most range of these scores.
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group 1": Use of EMLA cream, spray cream 1.5 grams at the patient's placement site, 60-45 minutes before placement, and covered with semi-permeable dressing. After 45 minutes, the dressing is removed. And the cream with cotton alcohol will be cleaned up to 70%, and the nurse will work. "Intervention group 2": Using an ice bag, 5 pieces of ice with dimensions of 4 × 2 × 2 cm are placed in latex gloves and placed for 3 minutes on the spot, then remove the ice bag and place With alcohol cotton, 70% is cleaned and done by the nurse. "Intervention group 3": Use 2% lidocaine gel for 5 minutes for 12 minutes in the lidocaine gel vein and apply a semi-permeable dressing. Then, with cotton alcohol, remove the 70% gel. The nurse will go through. "control group" will be routine care.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital in Shoushtar
Full name of responsible person
Shahnaz Rostami
Street address
Jundishapour University of Ahvaz, Esfand Street,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 7543
Email
rostami-sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohamad Badavi
Street address
Jundishapour University of Ahvaz, Esfand Street,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3336 7543
Email
rostami-sh@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shoushtar University of Medical Sciences, Khatam Al Anya Hospital
City
Shoushtar
Province
Khouzestan
Postal code
64519-84381
Phone
+98 61 3623 3891
Email
hematipour.a64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khatam Al Anbia Hospital
City
Shoushtar
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3623 3891
Email
hematipour.a64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Akram Hemmatipour
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Khatam Al Anbia Hospital
City
Shoushtar
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3623 3891
Email
hematipour.a64@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
I do not know
When the data will become available and for how long
I do not know
To whom data/document is available
I do not know
Under which criteria data/document could be used
I do not know
From where data/document is obtainable
I do not know
What processes are involved for a request to access data/document