RecruitingACTRN12622000943741

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


Sponsor

Samia Shaheen

Enrollment

16 participants

Start Date

Jun 20, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

For people on regular haemodialysis (kidney dialysis), needles must be inserted into an arteriovenous fistula — a surgically created connection between an artery and vein in the arm — at each session. This needle insertion is painful and can be a source of significant distress. This study compares two topical creams applied to the skin before needling: EMLA cream (a combination of prilocaine and lignocaine) versus piroxicam gel (an anti-inflammatory). Both are applied one hour before the dialysis session to reduce pain during the procedure. Participants receive both treatments at different sessions in a crossover design, so each person experiences both options without knowing which they are receiving at any given time. Pain is measured using a visual analog scale immediately after needling. Researchers hypothesise that EMLA cream will be more effective than piroxicam gel. You may be eligible if you have end-stage kidney disease, are on haemodialysis using a native arteriovenous fistula in your arm, and are between 18 and 75 years old. You would not be eligible if you have wounds or ulcers at the fistula site, known nerve damage that reduces pain sensation, atopic dermatitis, or allergies to either of the medications being tested.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 lo

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.


Locations(1)

KPK, Pakistan

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