CLINICAL TRIAL FOR THE TREATMENT OF PAIN IN HEMODIALYSIS PUNCTURE WITH LIDOCAINE / PRILOCAINE, VERSUS CHLOROETHYL, CROSSOVER RANDOMIZED STUDY

Phase 1

Conditions: Hemodialysis is the most commonly used therapy for renal replacement being the arteriovenous fistula used for vascular access . Venipuncture in patients causes stress, pain and anxiety.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-005334-22-ES

Lead Sponsor: HOSPITAL DE PALAMÓS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients over 18 with chronic kidney disease on hemodialysis for at least 3 months
Patients having an AVF needle access for hemodialysis is performed routinely .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Patients with inability to comunicate (mental state or language) or impaired mental status
Patients who are hospitalized
Presence of infection at the puncture site or puncture injury that hinders
Allergies or reactions to the product indicated

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare decreased pain during puncture of the AVF with 2 different methods : Using a mixture of local anesthetics ( EMLA : prilocaine / lidocaine) and a volatile spray (ethyl chloride ) for pain control in patients undergoing hemodialysis.<br>Compare the direct cost caused by both drugs.;Secondary Objective: ? Analyze the general characteristics of the patients.<br>? Assess the perception of pain by using EMLA pain assessment scales .<br>? Assess the perception of pain by using ethyl chloride pain assessment scales .<br>? Make a regression analysis between pain perception and the different variables considered.<br>? Make an analysis of mixed models to evaluate pain perception and the different variables considered .<br>? Assess patient preference .<br>? Analyze the difference in direct cost produced by both methods.;Primary end point(s): Pain: at the end of each dialysis session<br>Cost: end the two-month follow-up;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures