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Comparison of the effect of ice pack and lidocaine ointment in the pain of subcutaneous enoxaparin injection

Protocol summary

Study aim
The aim of this study is to compare the effect of topical lidocaine ointment and ice pack on the pain of enoxaparin injection
Design
In this study, 108 cardiac patients are placed in intervention group 1, 2, or 3 according to the inclusion criteria and selected random sampling by block random allocation
Settings and conduct
This study is a randomized, block-based clinical trial with 108 cardiac patients receiving enoxaparin and admitted to the cardiac intensive care unit of Amir Kabir Hospital in Arak. Patients with inclusion criteria are included. For intervention group 1, cryotherapy is used, for intervention group 2, lidocaine ointment is used and for the control group, no intervention is performed. Enoxaparin injection is performed in the same way in all patients by one person
Participants/Inclusion and exclusion criteria
Major entry requirements include: age between 30 and 65 years; ability to communicate and answer questions and show pain with visual analogue scale tools; stable clinical status; no drug addiction; no history of allergies to local anesthetics drugs Exclusion criteria include; cancellation of further study; discharge; transfer; death of the patient
Intervention groups
Group 1 is intervened with an ice pack for one minute. Immediately after removing the ice pack, the injection site is disinfected as usual and subcutaneous injection is performed Group 2 is treated with 5% lidocaine ointment in the amount of 2 g for 30 minutes. Then it is removed and subcutaneous injection is performed there is no intervention in the control group
Main outcome variables
Reduction of pain caused by enoxaparin injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200820048466N1
Registration date: 2020-09-13, 1399/06/23
Registration timing: prospective

Last update: 2020-09-13, 1399/06/23
Update count: 0
Registration date
2020-09-13, 1399/06/23
Registrant information
Name
Freydoun Shahivand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4342 2302
Email address
fshahivand93@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-20, 1399/06/30
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ice pack and lidocaine ointment in the pain of subcutaneous enoxaparin injection
Public title
Comparison of the effect of ice pack and lidocaine ointment in the pain of subcutaneous enoxaparin injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30-65 years Awareness Ability to communicate and answer questions and show the amount of pain Stability of the clinical condition No drug addiction No history of allergies to local anesthetics No known mental illness
Exclusion criteria:
Canceling Discharge Transfer Patient death
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 108 heart patients were selected according to the inclusion criteria and by available sampling and block random allocation, by assigning the letter A to the ice pack group, the letter B to the lidocaine group and the letter C to the control group in six cases. ABC, ACB, BAC, BCA, CAB, CBA are written on separate sheets and thrown into a container and one of the sheets is randomly taken out of the container and the composition written on it is written down and again. That sheet is thrown into the container. Because the sample size in this study is 108 patients, this operation should be repeated 36 times. Each time the composition written on each sheet is written in the sequence written on the previous sheet. Then, for each letter, a number from one to one hundred and eight is assigned to the letters written in sequence, and each letter is placed in an envelope and the letter number is written on the envelope. Each time a patient is selected, one of the envelopes is opened in the order written on the envelope and it is determined that the patient should be in intervention group 1, 2 or 3, they are divided into three groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,to avoid bias,the use of ice packs and lidocaine ointment and enoxaparin injection is performed by one person in the group and is measured by another person in the group
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak university of medicine
Street address
Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.ARAKMU.REC.1399.134

Health conditions studied

1

Description of health condition studied
Pain due to Enoxaparin injection
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Patient pain rate with VAS instrument
Timepoint
Immediately after injection
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Pain Rate
Timepoint
Immediately
Method of measurement
VAS

Intervention groups

1

Description
Intervention group : group 1 patients undergo ice bag intervention. one minute before the injection, the ice pack is placed on the site where the enoxaparin is to be performed. immediately after removing the ice pack, the injection site is disinfected in the usual way using normal saline and subcutaneous injection is performed by one person in both groups, immediately after the injection of the patients pain with VAS instrument measured and recorded.
Category
Treatment - Devices

2

Description
Intervention group: Group 2 patients underwent the intervention with 5% lidocaine ointment. 2 g equals 15 cm (from 5% lidocaine ointment tube weighing 15 g) was measured with a Scaltec laboratory scale with an accuracy of 0.01 g. After performing several measurements under the same conditions, the length of the ointment used was calculated to be 15 cm. Apply lidocaine on the calibrated pad and place it on the stand. After 30 minutes, the ointment is removed from the stand. Using a checklist, the possible side effects of lidocaine ointment are investigated and recorded. Side effects of topical lidocaine include redness and irritation of the lidocaine ointment . Using a normal saline impregnated pad, the injection site is cleansed and the subcutaneous injection is performed by one person in each of the three groups. Immediately after the injection, the patient's pain is measured and recorded with a VAS instrument.
Category
Treatment - Drugs

3

Description
Control group: The control group did not perform any intervention and immediately after injection, the patient's pain was measured and recorded with a VAS instrument
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Esmaiel Moshiri
Street address
Shahid Shiroudi Ave.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
it@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
President for research and technology
Street address
Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3526
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fereydoun Shahivand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
amoozesh@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fereydoun Shahivand
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
amoozesh@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ferydoun Shahivand
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sardasht Square
City
Arak
Province
Lorestan
Postal code
3848176941
Phone
+98 86 3417 3524
Email
amoozesh@arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Article
When the data will become available and for how long
2020
To whom data/document is available
researchers
Under which criteria data/document could be used
reseachers
From where data/document is obtainable
fshahivand93@yahoo.com
What processes are involved for a request to access data/document
email fshahivand93@yahoo.com
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