NCT01685658

Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30 minutes.

Detailed description

The secondary objectives of this study are: * To compare the efficacy (non-inferiority) of intravenous paracetamol and ketoprofen at 90 minutes (vns for pain). * To compare both arms in terms of other administered drugs (for pain). * To observe and compare side effects between the two arms: cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine. * To determine predictors for the use of intravenous morphine when treating renal colic. * To compare hospitalization rates between the two groups. * To compare patient satisfaction concerning care between the two groups (vns for satisfaction) * To observe and compare changes towards complicated renal colic (obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death)

Conditions

• Renal Colic
• Acute Renal Colic

Interventions

Type	Name	Description
DRUG	Intravenous ketoprofen	Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)
DRUG	Intravenous paracetamol	Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2012-09-14
• Last updated: 2020-08-12

Locations

2 sites across 1 country: France