Double-blind study with cross over design on 76 patients with acute coronary syndrome has done to evaluate the effect of application of EMLA cream on Enoxaparin sodium injection pain severity. Inclusion criteria: Having consent for participation in the study; being oriented to person, place and time; Having at least reading and writing ability; have no Associated diseases that can affect patient pain assessment (delirium, dementia or severe depression, severe visual and hearing impairment, moderate to severe diabetic neuropathy); Be able to speak in Persian.
Exclusion criteria: don't have willingness for participation in the study; having a continuous infusion of sedative medication such as: Midazolam; receiving of palliative drugs 2 hours before the injection.
in the first day enoxaparin injection was performed for patients in the morning and evening in a usual way by research partner. In the secound and third days, in the morning and evening EMLA cream and placebo crossoverly,two times a day, has applied for 60 min before injection. after passing 60 min, site has prepared and injection has done and pain severity has measured by Numerical Rating Scale(NRS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012112212N1
Registration date:2013-03-18, 1391/12/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-18, 1391/12/28
Registrant information
Name
Ali Asghar jesmi
Name of organization / entity
Mashhad university of Medical Science ( MUMS)
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
jesmiaa891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of Medical Science (MUMS)
Expected recruitment start date
2012-09-27, 1391/07/06
Expected recruitment end date
2012-11-15, 1391/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of EMLA cream on pain severity of enoxaparin sodium injection in patients with acute coronary syndrome
Public title
The effect of EMLA cream on pain severity of enoxaparin sodium injection
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Having consent for participation in the study؛being informed to person, place and time؛ Having the least reading and writing ability؛ haven't Associated diseases that can affect patient pain assessment (delirium, dementia or severe depression, severe visual and hearing impairment, moderate-to-severe diabetic neuropathy) ؛Be able to speak the Persian language.
Exclusion criteria: Having any tendency for participation to the study؛ having a noncontinuous infusion of sedative medication such as: Midazolam؛ receiving of palliative drugs 2 hours before the injection.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science (MUMS)
Street address
doctora cross road. college of nursing and midwifery
City
Mashhad
Postal code
9137913199
Approval date
2012-06-14, 1391/03/25
Ethics committee reference number
5111928
Health conditions studied
1
Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris
2
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
injection pain severity
Timepoint
60 min
Method of measurement
numerical rating scale (NRS)
Secondary outcomes
1
Description
fatigue
Timepoint
exactly before the injection
Method of measurement
fatigue siverity measurement visual scale
Intervention groups
1
Description
EMLA cream, 5mg tube , 1 gr ,60 min befor injection ,application 2inches of priumbilical area(overally two grams secound and theird days of study) 2inches of priumbilical area.
Category
Treatment - Drugs
2
Description
almond hand and face cream, Made in iran,1 gr each times 60 min before injection(overally two grams secound and theird days of study) 2inches of priumbilical area
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem center
Full name of responsible person
Ali Asghar Jesmi
Street address
Taghi Abad squer, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Science(MUMS)
Full name of responsible person
Ali Asghar Jesmi
Street address
College of Nurding and Midwifery, Doctora sq
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Science(MUMS)
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
Mashhad University of medical science (MUMS)
Full name of responsible person
Ali Asghar Jesmi
Position
MSc candidate
Other areas of specialty/work
Street address
doctora sq, college of nursing and midwifery
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1853 9775
Email
jesmiaa891@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science (MUMS)
Full name of responsible person
Ali Asghar Jesmi
Position
MSc candidate
Other areas of specialty/work
Street address
College of Nursing and Midwifery,Doctora sq
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
Email
jesmiaa891@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science (MUMS)
Full name of responsible person
Ali Asghar Jesmi
Position
MSc candidate
Other areas of specialty/work
Street address
college of nursing and midwifery, Doctora sq.
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1853 9775
Email
jesmiaa891@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)