Pain in Nephrolithiasis in whom Extracorporeal shock wave lithotripsy is indicated MedDRA version: 17.0 Level: HLT Classification code 10017926 Term: Gastrointestinal and abdominal pains (excl oral and throat) System Organ Class: 100000004856
Conditions
Interventions
Trade Name: DORMICUM 5MG/5ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MIDAZOLAM
CAS Number: 59467-70-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equ
Sponsors
INSTITUTO DE INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To analize pain intensity improvement at different time points during the procedure. - To analize the influence of the analgesic effect of the different strategies on ESWL outcome - To study the influence of BMI, size and composition of the Stone in pain intensity;Primary end point(s): To compare efficacy, in terms of pain intensity measured with VAS of 4 analgesic strategies in patients undergoing ESWL;Timepoint(s) of evaluation of this end point: At the end of the procedure;Main Objective: To compare the efficacy of four different analgesic strategies during ESWL procedure in patients with Nephrolithiasis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o To analyze changes in pain intensity during the procedure o To analyze the influence of the analgesic strategy on ESWL efficacy. o To analyze the influence of BMI and stone size, location and composition in pain intensity during the procedure. o To compare the need for rescue medication among the four analgesic strategies. o To compare early complications rate after ESWL. o To compare safety and tolerability among the four analgesic strategies. o To compare the patient satisfaction with the procedure and the received analgesic strategy.;Timepoint(s) of evaluation of this end point: At the end of the procedure | — |
Countries
Spain
Contacts
Public ContactLUCIA LLANOS JIMÉNEZ
INSTITUTO DE INVESTIGACION SANITARIA FUNDACION JIMENEZ DIAZ
Outcome results
None listed