The Effect of Cold Packs, Lidocaine and Flash Lights on Cannulation Pain in Hemodialysis Patients

NCT05822063 | Unknown Phase 3 DMC

• 1 other identifier: FAMASU/2023
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the effects of lidocaine ,ice packs and flash lights on the intensity of pain induced by arteriovenous cannulation in hemodialysis patients.

Conditions

Arteriovenous Graft Site Pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale(VAS)

  it is score 1 to 10 according to pain intensity( 1= better ,10= worst)

  one month ( 30 days)

Study Arms (4)

Lidocaine group

ACTIVE COMPARATOR

the skin site will be prepped first and then two puffs of lidocaine (20 mg) will be sprayed by the researcher from a 5-cm distance on the dermal surface near the needle insertion point. Five minutes after spraying, the skin surface at the site of arterial needle insertion will be disinfected with 70% alcohol-soaked cotton pads and the specific hemodialysis needles will be inserted into the vessels of the fistula area by the ward nurse

Drug: Lidocaine topical

cold packs

ACTIVE COMPARATOR

In the ice pack method, 5 pieces of ice measuring 5\*5 will be placed in latex gloves and covered with material cover. They were placed after the passage of 2 min on the hand at the site of fistula 5 min before making the puncture. Next, specific hemodialysis needles will be inserted in the vessels of fistula area by the ward nurse after disinfecting the fistula area with 70% alcohol-soaked cotton pads.

Other: cold packs

flash lights

ACTIVE COMPARATOR

the patient's face will be photographed. The photograph will be taken with a camera \[(Sony HVLHFL1 with luminance intensity approximately 100 cd, lighting distance approximately 11 Lux, flash shooting distance (1-5 m)\].

Device: flash lights

control

NO INTERVENTION

no intervention

Interventions

Lidocaine topical DRUG

lidocaine spray

Also known as: lidocaine spray

Lidocaine group

cold packs OTHER

ice packs

cold packs

flash lights DEVICE

flash lights by camera

flash lights

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will be willing to participate in the study.
• Patients who are diagnosed as chronic kidney disease \& undergoing haemodialysis with A.V. fistula of upper extremity currently used for haemodialysis which can be radio cephalic, radio basilic or brachio cephalic.
• Chronic kidney disease patients who are visiting regularly, minimum 2 times per week for haemodialysis.

You may not qualify if:

• \. Chronic kidney disease patients who are undergoing haemodialysis with other vascular access than A.V. fistula access.
• \. Patients who are allergic to cold therapy.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in clinical pharmacy

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 20, 2023
• Study Start: July 25, 2023
• Primary Completion: August 25, 2023
• Study Completion: September 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share