The aim of this study is to compare two pain relief methods of lidocaine ointment and xylocaine spray to reduce the pain of the fistulas needles in hemodialysis patients. For this purpose, a double blind experimental study is conduced on 50 hemodialysis patients.
Each time two needles are set aside for each patient; one is placed for the intervention and one for the placebo (vitamin D)
In the ointment groups before injecting the needle, we will use 10 mg of lidocaine ointment or two puffs of xylocaine spray. In the other needle place a placebo will be used. Finally, after 10 minutes the pain level will be determined by visual analog scale. All of the needles will be of the same material and size.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060615965N2
Registration date:2015-12-17, 1394/09/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-17, 1394/09/26
Registrant information
Name
Majid Kazemi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 7663
Email address
dr.kazemi.n@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2014-04-30, 1393/02/10
Expected recruitment end date
2014-10-02, 1393/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Lidocaine ointment and Xylocain Spray on reducing the pain of Fistulas needles in Hemodialysis Patients
Public title
Comparison of the effects of Lidocaine ointment and Xylocain Spray on reducing the pain of Fistulas needles in Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients without extensive skin; local infection disorders
Exclusion criteria: no consent
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rafsanjan University of Medical science
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
Iran
Approval date
2014-10-06, 1393/07/14
Ethics committee reference number
ir.rums.ac.8
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Pain
Timepoint
Immediately after entering stick
Method of measurement
Based on a numerical scale VAS
Secondary outcomes
empty
Intervention groups
1
Description
This study will be a crossover study. In the first instance one place of the Venipuncture will be used as a test and two puffs of xylocaine spray and in the other place the placebo (water) will be used. After ten minutes, pain at the site by another person (nurse) using a visual analog scale pain will be examined.
Category
Treatment - Drugs
2
Description
On the second time one place of the Venipuncture will be used as a test and 10 mg lidocaine ointment will be applied and in the other place a placebo (A+D ointment) will be used. After ten minutes, pain at the site using a visual analog scale pain will be investigated by another person (nurse).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital, Rafsanjan
Full name of responsible person
Dr.Majid Kazemi
Street address
Faculty of Nursing and midwifery, Rafsanjan
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Majid Kazemi
Position
Phd
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
dr.kazemi.n@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)