Study to evaluate clinical efficacy of four different strategies to control pain in patients undergoing Lithotripsy
- Conditions
- Pain in Nephrolithiasis in whom Extracorporeal shock wave lithotripsy is indicatedMedDRA version: 17.0Level: HLTClassification code 10017926Term: Gastrointestinal and abdominal pains (excl oral and throat)System Organ Class: 100000004856Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2014-001930-26-ES
- Lead Sponsor
- INSTITUTO DE INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
?Diagnosis of renal lithiasis located in pelvis or medium or superior calix, Pacientes diagnosticados de litiasis renal, en pelvis o cálices medios o superiores, for which ESWL is indicated.
?Age ? 18 years old.
?Subjects that give their written consent after receiving appropriate information about the aim, procedures, potential benefits and harms of the study, and that their participation is voluntary.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
?Subjects unable to understand the study procedures and/or to collaborate during its development.
? Not willing to give their written consent.
?ESWL contraindicated
?Having a double J catheter.
?Lithiasis bigger than 2cm
?Chronic opioid use
?Present treatment with antiplatelet of anticoagulant agents.
?Previous ESWL
?Contraindication to use of any of the study medications (dormicum, fentanest, enantyum of kalinox).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method