Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

Phase 4

Withdrawn

• Conditions: Renal Colic; Acute Renal Colic
• Interventions: Drug: Intravenous ketoprofen; Drug: Intravenous paracetamol

• Registration Number: NCT01685658
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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)

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Study Start: 2016-09
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketaprofen	Intravenous ketoprofen	Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen
Paracetamol	Intravenous paracetamol	Patients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol

Primary Outcome Measures

Name	Time	Method
Change in vns for pain	baseline to 30 minutes	Verbal numeric scale ranging from 0 to 10.0.

Secondary Outcome Measures

Name	Time	Method
Change in vns for pain	baseline to 90 minutes	Verbal numeric scale ranging from 0 to 10.0.
Quantity of (posology) tramadol administered	discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) phloroglucinol administered	discharge from emergency ward (estimated max of 24 hours)
Was morphine administered? yes/no	baseline (minute 0)
Quantity of (posology) morphine administered	discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Nefopam administered	discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Alfuzosine administered	discharge from emergency ward (estimated max of 24 hours)
Presence/absence of complications	week 1	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
Was the patient hospitalized? yes/no	week 1
VNS for patient satisfaction concerning care	week 1
Evolution towards a complicated renal colic	week 1	Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death

Trial Locations

Locations (2)

CH d'Alès; 🇫🇷 Alès, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 9, France