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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005334-22-ES

Enrollment

Unknown

Registered

2016-05-17

Start date

2016-05-31

Completion date

Unknown

Last updated

2016-06-20

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

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.

Interventions

Trade Name: CLORETILO CHEMIROSA Product Name: CLORETILO CHEMIROSA Product Code: 75-00-3 Pharmaceutical Form: Cutaneous spray INN or Proposed INN: ETHYL CHLORIDE CAS Number: 75-00-3 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. Compare the direct cost caused by both drugs.;Secondary Objective: ? Analyze the general characteristics of the patients. ? Assess the perception of pain by using EMLA pain assessment scales . ? Assess the perception of pain by using ethyl chloride pain assessment scales . ? Make a regression analysis between pain perception and the different variables considered. ? Make an analysis of mixed models to evaluate pain perception and the different variables considered . ? Assess patient preference . ? Analyze the difference in direct cost produced by both methods.;Primary end point(s): Pain: at the end of each dialysis session Cost: end the two-month follow-up;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

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. Compare the direct cost caused by both drugs.;Secondary Objective: ? Analyze the general characteristics of the patients. ? Assess the perception of pain by using EMLA pain assessment scales . ? Assess the perception of pain by using ethyl chloride pain assessment scales . ? Make a regression analysis between pain perception and the different variables considered. ? Make an analysis of mixed models to evaluate pain perception and the different variables considered . ? Assess patient preference . ? Analyze the difference in direct cost produced by both methods.;Primary end point(s): Pain: at the end of each dialysis session Cost: end the two-month follow-up;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Spain

Contacts

Public ContactSECRETARIA TÈCNICA DE RECERCA

HOSPITAL DE PALAMÓS

recerca@ssibe.cat34972600026

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026