E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
La hemodiálisis es la terapia de reemplazo renal más usada siendo la fístula arteriovenosa la utilizada para el acceso vascular. La venopunción provoca en los pacientes tensión, dolor y ansiedad. |
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E.1.1.1 | Medical condition in easily understood language |
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. |
La hemodiálisis es la terapia de reemplazo renal más usada siendo la fístula arteriovenosa la utilizada para el acceso vascular. La venopunción provoca en los pacientes tensión, dolor y ansiedad. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Comparar la disminución del dolor durante la punción de la FAV con 2 métodos diferentes: Usando una mezcla de anestésicos locales (EMLA: prilocaína/lidocaína) y un aerosol volátil (cloruro de etilo) para el control del dolor en pacientes sometidos a hemodiálisis. Comparar el costo directo ocasionado por ambos fármacos. |
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E.2.2 | Secondary objectives of the trial |
? 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. |
? Analizar las características generales de los pacientes. ? Valorar la percepción del dolor usando EMLA mediante escalas de valoración del dolor. ? Valorar la percepción del dolor usando cloruro de etilo mediante escalas de valoración del dolor. ? Hacer un análisis de regresión entre la percepción del dolor y las diferentes variables consideradas. ? Hacer un análisis de modelos mixtos para valorar percepción del dolor y las diferentes variables consideradas. ? Valorar la preferencia de los pacientes. ? Analizar la diferencia de costo directo producidos por ambos métodos. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 . |
Pacientes mayores de 18 años con enfermedad renal crónica en programa de hemodiálisis al menos durante 3 meses Pacientes que tenga una FAV como acceso para hemodiálisis que se realice punción de forma rutinaria. |
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E.4 | Principal 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 |
Pacientes con imposibilidad de comunicares (estado mental o idioma) o deterioro del estado mental Pacientes que se encuentren hospitalizados Presencia de infección en la zona de punción o lesión que dificulte la punción Alergia o reacción al producto indicado |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain: at the end of each dialysis session Cost: end the two-month follow-up |
Dolor: al acabar cada sesión de diálisis Coste: terminar los dos meses de seguimiento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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When the last visit is made to last patient included |
Cuando se haga la última visita al último paciente incluído |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |