This study aims to compare the effect of EMLA cream and local cold application on the occurrence of pain at the injection site in subcutaneous Enoxaparin injections. The occurrence of pain is one of the most prevalent causes of suffering patients and the most common reason of admission patients to the health centers . This is commonly caused by mechanical, chemical, thermal stimuli . these stimuli lead to some problems such as bruise and pain at the injection site in subcutaneous Enoxaparin injection hospitalized patients in this study are 53 patients who receive Enoxaparin randomly and they were divided in to three groups. in the first group, 1.5 gram of EMLA cream will apply to the injection site and then injection will be performed. In the second group, 4×2×2 size of ice will apply to the injection site for 5 minutes before the injection and then injection will be performed and there is not any injection in third group .following each injection, the patient's pain intensity by using VAS method will be measured after injection, by 5 and 10 minutes after the injection and then the severe pain intensity will be established as the criteria for pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100914956N1
Registration date:2014-01-22, 1392/11/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-22, 1392/11/02
Registrant information
Name
Somayeh Zeighamian
Name of organization / entity
Medical Univercity of Shahid Sadoughi Yazd,school of Nursing & M
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
n-zeighamian@ysrbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-12-27, 1392/10/06
Expected recruitment end date
2014-04-08, 1393/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Emla cream and Cold compress on the injection site pain intensity in Enoxaparin
Public title
Comparison of Emla cream and Cold on the injection site pain in Enoxaparin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 years old; full consciousness; ability to communicate; not a severe pain in other areas; no history of prescribed Enoxaparin; no scarring and lesions at the injection site and no history of allergy to lidocaine & Prilocain.
Exclusion criteria: loss of consciousness; sensorimotor disorders; injection of other drug in the abdomen during the study, and two days before the study; prescription of narcotic and non-narcotic analgesics 2 hours before injection; allergy to EMLA cream; the development of diabetic neuropathy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
53
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical University of Shahid Sadoughi, Yazd
Street address
School of Nursing and Midwifery, Bu Ali St, Safaeyeh Avenue Yazd
City
Yazd
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
105274
Health conditions studied
1
Description of health condition studied
Injection pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Injection pain
Timepoint
Immediate,5 &10 minute after injection
Method of measurement
Using the VAS scale & record severe pain intensity
Secondary outcomes
empty
Intervention groups
1
Description
First method: Injection Enoxaparin without interference(Subcutaneous injection of Enoxaparin-Na for 10 seconds in the right or left side of abdomen)
Category
Prevention
2
Description
Second method:In this method 1/5 gr Emla cream is placed on the injection site with holder dressing 60 minute before the injection and dressing is removed after the one hour, then area is cleaned and injection is performed
Category
Prevention
3
Description
Third method: In this method, a piece of ice the size of 4*2*2 Cm is placed inside the latex gloves and is placed on the injection site 5 minute before the injection
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital,Yazd
Full name of responsible person
Somayeh Zeighamian
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & Midwifery
Full name of responsible person
Farnia Farahnaz,PhD
Street address
School of Nursing & Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & Midwifery
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
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & M
Full name of responsible person
Somayeh Zeighamian
Position
Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
somayehz196@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & M
Full name of responsible person
Somayeh Zeighamian
Position
Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
Phone
+98 35 1824 1751
Fax
Email
somayehz196@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd, School of Nursing & M
Full name of responsible person
Somayeh Zeighamian
Position
Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Bu Ali St, Safaeyeh Avenue
City
Yazd
Postal code
8915833878
Phone
+98 35 1824 1751
Fax
+98 35 1824 9705
Email
somayehz196@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)