Comparison of the effect of topical application of piroxicam gel, diclofenac gel and emla on pain relief of angiocatheter insertion in patients
Design
A parallel-group, single-blind, randomized clinical trial in 123 patients
Settings and conduct
The number of 123 patients admitted to surgery department of Valiasr Hospital in Arak, provided that they meet the inclusion criteria and do not have the exclusion criteria, after fully explaining the conditions of the study and obtaining informed consent, will be investigated as the target population. After recording basic vital signs (blood pressure and heart rate), patients will be randomly divided into three groups. The data collection tool in this research will be a personal information questionnaire (age, height, history of venipuncture , etc.) and VAS scale to measure the intensity of pain caused by venipuncture. In all patients, venous cannulation will be done from a specific area, which is the veins on the back of the hand. Also, in all patients, an Angiocath with the same number will be used, and all cannulations will be performed by an experienced nurse. After determining the patient group for blinding, the researcher will cover the tube of intervention drugs with paper covers and then apply the drug in the desired position in each group.
Participants/Inclusion and exclusion criteria
Age range from 15 to 65 years؛ ASA class I, II؛ absence of pain for any reason
Intervention groups
First group: Piroxicam (P), 10 mg of piroxicam gel is placed in the target area (veins on the back of the hand) in dimensions of 2 x 4 cm.
The second group: diclofenac (D), 100 mg of diclofenac gel is placed in the target area (veins on the back of the hand) in dimensions of 2 x 4 cm.
The third group: Emla (E), 1.5 grams of cream is placed in the desired place (veins on the back of the hand) in dimensions of 2 x 4 cm.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180107038251N8
Registration date:2023-06-12, 1402/03/22
Registration timing:prospective
Last update:2023-06-12, 1402/03/22
Update count:0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Nazanin Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 1308
Email address
nazaninamini69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-21, 1402/03/31
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical application of piroxicam gel, diclofenac gel and emla on pain relief of angiocatheter insertion in patients
Public title
Effect of topical application of piroxicam gel, diclofenac gel and emla on pain relief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 15 to 65 years of old
ASA I , II
Absence of pain for any reason
Absence of verbal, mental and visual disability
Absence of pregnancy
No history of drug abuse
Not using painkillers in the last 24 hours
Absence of sensitivity to NSAID
Absence of sensitivity to local anesthetics
Absence of allergy to vitamin A + D ointment
Exclusion criteria:
Lack of patient consent to participate or continue the study
Body mass index more than 30
Presence of peripheral vascular disease and Raynaud's syndrome
The presence of scleroderma
Failure of the researcher in the first attempt at cannulation
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the samples in three groups, we prepare beads of the same gender and the same shape as the number of samples and write the number of the desired group on each one, then we put the beads in a container and ask the research units to take out one of the beads and in this way the samples will be randomly placed in one of the three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
After determining the patient group for blinding, the researcher will cover the tube of intervention drugs with paper covers and then apply the desired drug in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
1234
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.ARAKMU.REC.1401.300
Health conditions studied
1
Description of health condition studied
intensity of pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Intensity of pain
Timepoint
at 0, 5, 10, 15, 30, and 45 minutes after cannulation
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Piroxicam (P), in the amount of 10 mg of piroxicam gel, is placed in the desired place (veins on the back of the hand) in dimensions of 2 x 4 cm.
Category
Prevention
2
Description
Intervention group:Diclofenac (D), 100 mg of diclofenac gel is placed in the desired place (veins on the back of the hand) in dimensions of 2x4 cm.
Category
Prevention
3
Description
Intervention group:Emla (E), 1.5 grams of cream is placed in the desired place (veins on the back of the hand) in dimensions of 2 x 4 cm.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesameddin Modir
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3507
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davood Hekmatpou
Street address
Deputy of Research and Technology, Arak University of Medical Sciences, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3505
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
Nazanin Amini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesameddin Modir
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3507
Email
modir.he@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
1234
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com
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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
2024
To whom data/document is available
En Researchers working in academia and academia
Under which criteria data/document could be used
I have no conditions
From where data/document is obtainable
Arak University of Medical Sciences, Alamoll Huda Street, Railroad Street Arak, Markazi Province, Iran
What processes are involved for a request to access data/document
Visit to Arak Medical University, Faculty of Paramedicine, Anesthesiology Department, Ms. Amini