Comparison of the efficacy of IV paracetamol and IV ketoprofen in the treatment of renal colic in emergency department : a two-center double blind randomized study.

INTERVENTION: Trade Name: Profenid 100mg Product Name: profenid Pharmaceutical Form: Lyophilisate for solution for injection Trade Name: Paracetamol MacoPharma Product Name: Paracetamol marco pharma Pharmaceutical Form: Solution for injection CONDITION: Comparison of the efficacy of IV paracetamol and IV ketoprofen in the treatment of renal colic Therapeutic area: Diseases [C] ‐ Symptoms and general pathology [C23] PRIMARY OUTCOME: Main Objective: The research hypothesis of our study is that there is no difference between paracetamol and ketoprofen in intravenous use interms of analgesic efficacy for the treatment of renal colic.; The main objective of this study was to demonstrate non ‐inferiority of the efficacy of treatment with IV paracetamol vs treatment with IV ketoprofen in the treatment of renal colic at the emergency reception , measured by the difference between pain felt at T0 and after 30 minutes of treatment mesured by numeric pain rating scale. Primary end point(s): pain assessment 30 minutes after injection Secondary Objective: The secondary objectives of this study are :; A‐ To compare the noninferiority of IV paracetamoland IV ketoprofen pain on 90 minutes of treatment assessed by NRS; B‐ To compare between the two groups the use of another molecule for pain relief ; C‐ To observe and compare the side effects between the two groups : cutaneous manifestation , edema, bronchospasm , nausea, vomiting , headache, palpitation , chest pain, dizziness, impairment of consciousness , dyspnea, acute retention of urine.; From D‐ highlight predictors of the use of IV morphine in the treatment of simple renal colic; E‐ To compare the rate of hospitalization in the two groups; F‐ To evaluate patient satisfaction; G‐ To observe and compare the evolution of a complicated renal colic ( obstructive pyelonephritis , hyperalgesia , urinary tract rupture , need for surgical drainage , sepsis , death) Timepoint(s) of evaluation of this end point: 30 minutes SECONDARY OUTCOME: Secondary end point(s): pain assessment 90 minutes after injection; Administration of another painkiller; Summary of adverse events; hospitalization; Patient satisfaction Timepoint(s) of evaluation of this end point: T0, 30 min, 90 min, end of hospitalization, 1 week INCLUSION CRITERIA: • informed consent • The patient is available for telephone follow‐up to one week • The patient is at least 18 years old. • suspected renal colic 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 338 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 338