This clinical trial will be conducted on a group of 40 patients with arteriovenous fistula in Dialysis Ward of Shahid Rahnemoon Hospital in Yazd. The aim of this study is to compare three pain relief methods of lidocaine spray, EMLA cream and Ice bag to reduce the pain of the fistulas needles in hemodialysis patients. This study will be conducted as a Crossover design. forty hemodialysis patients of hemodialysis ward who are eligible are selected and Three interventions including EMLA Cream, Lidocain spray and Ice bag are performed for any patient in sequential sessions of hemodialysis with randomly assignment before inserting the needle into the fistula site. The exclusion criteria are: cold intolerance, allergy to lidocaine constituents and peripheral vessels damage. Interventions will include the use of ice bag for 5 minutes before inserting the needle into the fistula site, 2 puffs of lidocaine 5 minutes before inserting the needle into the fistula site and application of EMLA cream 20 minutes before inserting the needle into the fistula site. The dependent variable is pain on needle insertion into the arteriovenous fistula which will be studied using visual analogue Scale. At first, the acuity of pain on needle insertion into fistula is measured for each patient 2 minutes after insertion at three different times without any therapeutic intervention. Then, the pain acuity on needle insertion will be measured for each patient 3 times (totally 9 times) for each of the three intervention modalities using the visual analogue scale 2 minutes after needle insertion. Next, the data would be analyzed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102224655N1
Registration date:2016-02-06, 1394/11/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Samaneh Mirzaei
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3525 7672
Email address
mirzaeis@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University Of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of EMLA Cream, Lidocaine spray and Ice bag on pain during intravenous cannulation in Hemodialysis Patients
Public title
The effect of EMLA Cream, Lidocaine spray and Ice bag on pain intensity during insertion of vascular needles in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: History of at least three months of hemodialysis through fistula and lack of any problem in accessing vessels
Exclusion criteria: Cold intolerance, allergy to lidocaine constituents and peripheral vessels damage
Age
From 15 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard
City
Yazd
Postal code
Approval date
2015-09-27, 1394/07/05
Ethics committee reference number
ir.ssu.rec.1394.85
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory Care For Dialysis
Primary outcomes
1
Description
Pain
Timepoint
2 minutes after insertion the needle into the fistula site
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention: The application of EMLA Cream 5% (Contains 25 mg/g of Lidocaine and 25 mg/g of Prilocaine) 20 minutes before inserting the needle into the fistula site
Category
Treatment - Drugs
2
Description
Second intervention: The use of ice bag for 5 minutes before inserting the needle into the fistula site
Category
Other
3
Description
Third intervention: The application 2 puffs of lidocaine 10% spray (each puff include 10 mg lidocaine) 5 minutes before inserting the needle into the fistula site
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnemoun Hospital of Yazd
Full name of responsible person
Samaneh Mirzaei
Street address
Shahid Rahnemoun Hospital, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Yazd University of Medical Sciences
Full name of responsible person
Dr Mostafa Javadi
Street address
In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Yazd University of Medical Sciences
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
Yazd School of Nursing and Midwifery
Full name of responsible person
Samaneh Mirzaei
Position
Msn in Critical Care Nursing
Other areas of specialty/work
Street address
Yazd School of Nursing and Midwifery؛ In Front of the Infertility Center؛ Safaieh street؛ Bu Ali Boulevard
City
Yazd
Postal code
Phone
+98 35257672
Fax
mirzaeis@ssu.ac.ir
Email
sama.m2113@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoghi Yazd University of Medical Sciences
Full name of responsible person
Dr Mostafa Javadi
Position
Phd In Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery Yazd؛ In Front of the Infertility Center؛ Safaieh street؛ Bu Ali Boulevard
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
javadinurse@gmail.com, javadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences, School of Nursing and Midwifery Yazd
Full name of responsible person
Samaneh Mirzaei
Position
Msn In Critical Care Nursing
Other areas of specialty/work
Street address
In Front of the Infertility Center, Safaieh street, Bu Ali Boulevard
City
Yazd
Postal code
Phone
+98 35 3525 7672
Fax
mirzaeis@ssu.ac.ir
Email
sama.m2113@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)