Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000943741
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
4/07/2022
Date last updated
4/07/2022
Date data sharing statement initially provided
4/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of EMLA cream with piroxicam gel for reducing pain associated with needling of arteriovenous fistula during haemodialysis
Scientific title
Comparison of prilocaine/ lidocaine cream with piroxicam gel for reducing pain during cannulation of arteriovenous fistula for adults with end stage renal disease undergoing haemodialysis
Secondary ID [1] 307279 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end stage renal disease 326542 0
Haemodialysis 326780 0
Condition category
Condition code
Renal and Urogenital 323802 323802 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EMLA cream is a combination of two local anaesthetic agents (Prilocaine 2.5% and Lidocaine 2.5%) which is relatively easy to apply on arteriovenous fistula site. The patients will clean the skin at local site with alcohol swab and then apply a standard dose of 2.5 grams EMLA cream in a thin layer sixty minutes before reaching the dialysis unit. This would be covered with an adhesive tape provided to the patients. Arteriovenous fistulas would be punctured with 17G Fistula needles by trained staff. Patients would do this twice in successive haemodialysis session. Adherence to intervention would be monitored through regular inspections carried out before start of haemodialysis sessions by the dialysis nurses. Following these two haemodialysis sessions, there would be a wash out period of one week before the participants get shifted to the other intervention group. During this week, no medicines would be applied locally.
Intervention code [1] 323720 0
Treatment: Drugs
Comparator / control treatment
Patients in this group will follow the same procedure as in the interventional/ exposure group, but with piroxicam gel. This would also be applied one hour before the start of two successive haemodialysis sessions.
Control group
Active

Outcomes
Primary outcome [1] 331589 0
Intensity of pain during arteriovenous fistula needling, assesses by a numerical rating scale ranging from 0 (no pain). to 10 (maximum possible pain)
Timepoint [1] 331589 0
At the time of arteriovenous fistula needling
Secondary outcome [1] 410353 0
None
Timepoint [1] 410353 0
None

Eligibility
Key inclusion criteria
Patients with end stage renal disease, undergoing haemodialysis with a native upper limb arteriovenous fistula
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of tunnelled dialysis catheters or arteriovenous grafts for haemodialysis
Unwilling patients
Known Hypersensitivity to any ingredient of the agents
Patients with ulcer/ wound at fistula site
Neuropathies causing loss of pain sensation
Atopic dermatitis
Co-morbidity resulting in participants' inability to validating the visual analog scale, e.g.,altered sensorium, psychiatric patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was done using a randomization table created by computer software (i.e. computerized sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/06/2022
Date of last participant enrolment
Anticipated
11/07/2022
Actual
Date of last data collection
Anticipated
8/08/2022
Actual
Sample size
Target
16
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 24816 0
Pakistan
State/province [1] 24816 0
KPK

Funding & Sponsors
Funding source category [1] 311576 0
Self funded/Unfunded
Name [1] 311576 0
Samia Shaheen
Country [1] 311576 0
Pakistan
Primary sponsor type
Individual
Name
Samia Shaheen
Address
Department of Medicine, Combined Military Hospital, Mall Road, Peshawar Cantonment, KPK, Pakistan
Country
Pakistan
Secondary sponsor category [1] 312997 0
None
Name [1] 312997 0
Address [1] 312997 0
Country [1] 312997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311025 0
Ethics Review Committee for Medical and Biomedical Research
Ethics committee address [1] 311025 0
Ethics committee country [1] 311025 0
Pakistan
Date submitted for ethics approval [1] 311025 0
Approval date [1] 311025 0
01/06/2022
Ethics approval number [1] 311025 0
00212/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119734 0
Dr Samia Shaheen
Address 119734 0
Department of Medicine, Combined Military Hospital, Mall Road, Peshawar Cantonment, KPK, Pakistan,
Country 119734 0
Pakistan
Phone 119734 0
+923000593566
Fax 119734 0
Email 119734 0
[email protected]
Contact person for public queries
Name 119735 0
Samia Shaheen
Address 119735 0
Department of Medicine, Combined Military Hospital, Mall Road, Peshawar Cantonment, KPK, Pakistan,
Country 119735 0
Pakistan
Phone 119735 0
+923000593566
Fax 119735 0
Email 119735 0
[email protected]
Contact person for scientific queries
Name 119736 0
Samia Shaheen
Address 119736 0
Department of Medicine, Combined Military Hospital, Mall Road, Peshawar Cantonment, KPK, Pakistan,
Country 119736 0
Pakistan
Phone 119736 0
+923000593566
Fax 119736 0
Email 119736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, and up to 1 year thereafter
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For meta-analyses
How or where can data be obtained?
The data set would be available on Harvard Dataverse and ResearchGate. Interested persons could contact the Principal Author for the links, after the article has been published in a journal.
email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.