Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations (PIVKIV)

Centre Hospitalier Universitaire de Nīmes

Status and phase

Withdrawn

Phase 4

Conditions

Acute Renal Colic

Renal Colic

Treatments

Drug: Intravenous ketoprofen

Drug: Intravenous paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT01685658

LOCAL/2012/PGC-01

2015-002381-23 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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)

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must have given his/her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is available for a telephone interview at week 1
Patient consulting at the Nîmes University Hospital emergency ward with suspicion of renal colic

Exclusion criteria

The patient is participating in another study
The patient is in an exclusion period determined by a previous study
The patient is under judicial protection, under tutorship or curatorship
The patient refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant, parturient, or breastfeeding
The patient has a contraindication for a treatment used in this study
The patient has an allergy to ketoprofen or paracetamol, a history of gastric or intestinal ulcers, bleeding disorders, history of asthma triggered by taking ketoprofen or substances with similar activity such as other NSAIDs or aspirin
The patient has a fever or is hemodynamically unstable, oligoanuria
The patient presents with an initial verbal numeric pain score of 10/10.
The patient has a history of aneurysm or aortic dissection, history of renal transplantation, history of renal or hepatic insufficiency
The patient took paracetamol or ketoprofen 4 hours before emergency treatment.