Clinical trial NCT01685658: Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations
Official title: Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Renal Colic
Acute Renal Colic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change in vns for pain
timeFrame: baseline to 30 minutes
Secondary outcomes:
measure: Change in vns for pain
timeFrame: baseline to 90 minutes
measure: Quantity of (posology) tramadol administered
timeFrame: baseline (minute 0)
measure: Quantity of (posology) tramadol administered
timeFrame: 30 minutes
measure: Quantity of (posology) tramadol administered
timeFrame: 90 minutes
measure: Quantity of (posology) tramadol administered
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Quantity of (posology) phloroglucinol administered
timeFrame: baseline (minute 0)
measure: Quantity of (posology) phloroglucinol administered
timeFrame: 30 minutes
measure: Quantity of (posology) phloroglucinol administered
timeFrame: 90 minutes
measure: Quantity of (posology) phloroglucinol administered
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Was morphine administered? yes/no
timeFrame: baseline (minute 0)
measure: Quantity of (posology) morphine administered
timeFrame: 30 minutes
measure: Quantity of (posology) morphine administered
timeFrame: 90 minutes
measure: Quantity of (posology) morphine administered
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Quantity of (posology) Nefopam administered
timeFrame: baseline (minute 0)
measure: Quantity of (posology) Nefopam administered
timeFrame: 30 minutes
measure: Quantity of (posology) Nefopam administered
timeFrame: 90 minutes
measure: Quantity of (posology) Nefopam administered
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Quantity of (posology) Alfuzosine administered
timeFrame: baseline (minute 0)
measure: Quantity of (posology) Alfuzosine administered
timeFrame: 30 minutes
measure: Quantity of (posology) Alfuzosine administered
timeFrame: 90 minutes
measure: Quantity of (posology) Alfuzosine administered
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Presence/absence of complications
timeFrame: baseline (minute 0)
measure: Presence/absence of complications
timeFrame: 30 minutes
measure: Presence/absence of complications
timeFrame: 90 minutes
measure: Presence/absence of complications
timeFrame: week 1
measure: Was the patient hospitalized? yes/no
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Was the patient hospitalized? yes/no
timeFrame: week 1
measure: VNS for patient satisfaction concerning care
timeFrame: week 1
measure: Evolution towards a complicated renal colic
timeFrame: discharge from emergency ward (estimated max of 24 hours)
measure: Evolution towards a complicated renal colic
timeFrame: week 1
Other outcomes:
Locations:
city: Alès
country: France
facility: CH d'Alès
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pierre-Géraud Claret, MD
role: PRINCIPAL_INVESTIGATOR
References: