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Comparison of EMLA cream with piroxicam gel for reducing pain associated with needling of arteriovenous fistula during haemodialysis

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000943741
Enrollment
8
Registered
2022-07-04
Start date
2022-06-20
Completion date
2022-07-11
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pain during needling of arteriovenous fistulas is problematic for most of the patients. This study aims to compare two strategies to reduce this: dermal application of prilocaine/ lignocaine cream or piroxicam gel at the local site one hour before the dialysis session. Patients would receive both these medicines sequentially, though they would not be knowing which medicine they have received. We will compare the degree of pain perceived during needling and compare the two treatment options. It is hypothesized that prilocaine/ lignocaine cream is superior to piroxicam gel for reducing pain during cannulation of arteriovenous fistula.

Interventions

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

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.

Sponsors

Samia Shaheen
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Patients with end stage renal disease, undergoing haemodialysis with a native upper limb arteriovenous fistula

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026