Determining and comparing the effect of cold needle and lidocaine spray on the intensity of pain caused by the insertion of vascular needles in hemodialysis patients of hospitals covered by Rafsanjan University of Medical Sciences, 2024
Design
A randomized, blinded, controlled clinical trial
Settings and conduct
This study will be conducted on 30 hemodialysis patients referred to the dialysis department of Ali Ibn Abi Talib Rafsanjan and Hazrat Wali Asr Anar hospitals. The order of interventions including lidocaine spray, placebo lidocaine spray, cold needle or being in the control group for each patient is determined by lottery
Participants/Inclusion and exclusion criteria
Using fistula for hemodialysis
Not using painkillers or narcotics 6 hours before hemodialysis
No neuropathy
No blindness and deafness
Willingness to participate in the study
Not allergic to lidocaine
Death
Change of residence or travel
If the cannulation process is done more than once
Intervention groups
Group cold needle
Control group
Group 10%lidocaine spray
Plasebo group
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131228015965N24
Registration date:2024-09-22, 1403/07/01
Registration timing:prospective
Last update:2024-09-22, 1403/07/01
Update count:0
Registration date
2024-09-22, 1403/07/01
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
Expected recruitment start date
2024-09-28, 1403/07/07
Expected recruitment end date
2024-11-09, 1403/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cold needle and lidocaine spray on the intensity of pain caused by vascular needles insertion in hemodialysis patients
Public title
Comparison of the Effect of cold needle and lidocaine spray on the intensity of pain caused by vascular needles insertion in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Using a fistula for hemodialysis
Not using painkillers or narcotics 6 hours before hemodialysis
No neuropathy
Not allergic to lidocaine
Willingness to participate in the study
No blindness and deafness
Exclusion criteria:
Using catheter for hemodialysis
Any problem in vascular accessibility Peripheral vascular disease Unsuccessful puncture at the first attempt.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient enters the study 4 times and each patient is his own control group. And by a simple randomization method, using a lottery, it is determined for each patient which intervention will be treated in each session. Each intervention or placement in the control group is assigned a number from one to four, then a lottery is conducted for each patient and the order of interventions is determined. For example, patient number one, his first intervention is cold needle, then a week later his second intervention is placebo, then control group and finally lidocaine spray. Or, for example, out of thirty patients, seven of them will have their first cold needle intervention determined by lottery. And five patients, their first intervention is placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the pain evaauator cannot distinguish the container containing lidocaine spray from the container containing distilled water by using two completely similar containers, and the pain evaluator will not know the executive interventions.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd., Medical University Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2024-09-11, 1403/06/21
Ethics committee reference number
IR.RUMS.REC.1403.086
Health conditions studied
1
Description of health condition studied
Pain caused by Vascular needles in hemodialysis patient
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)
Primary outcomes
1
Description
The intensity of pain caused by the insertion of vascular needles
Timepoint
The intensity of pain caused by the insertion of vascular needles will be measured immediately after the intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10% lidocaine spray, two puffs from a distance of five centimeters in the place where the needle is inserted, five minutes before inserting the vascular needles.
Category
Treatment - Drugs
2
Description
Intervention group: Placebo lidocaine spray, which uses distilled water in a container similar to the lidocaine spray container and two puffs from a distance of five centimeters, five minutes before entering the sample of vascular needles
Category
Placebo
3
Description
Intervention group: Fistula cannulation with vascular needles kept at -10_ -13 degrees Celsius for 24 hours
Category
Treatment - Devices
4
Description
Control group: Performing fistula cannulation in the common way in the hemodialysis department
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Taleb Hospital and Vali Asr Hospital
Full name of responsible person
Majid kazemi
Street address
Imam Ali Blvd., Medical University Sciences
City
Rafsanjan and Anar
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
Dr.kazemi.n@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Imam Ali Blvd., Medical University Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
Dr.Kazemi.n@rums.ac.ir
Grant name
Dr Reza Vazirinejad
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
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd., Medical University Scienes
City
رفسنجان
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
Dr.Kazemi.n@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Majid Kazemi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd., Medical University Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
Dr.Kazemi.n@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr Majid Kazemi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd., Medical University Sceinces
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3425 7663
Email
Dr.Kazemi.n@rums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD