Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

NCT ID: NCT01685658

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-03-31

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)

Conditions

Renal Colic; Acute Renal Colic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketaprofen

Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic.

Intervention: intravenous ketaprofen

Group Type: ACTIVE_COMPARATOR

Intravenous ketoprofen

Intervention Type: DRUG

Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)

Paracetamol

Patients randomized to this arm will receive intravenous paracetamol when treating renal colic.

Intervention: intravenous paracetamol

Group Type: EXPERIMENTAL

Intravenous paracetamol

Intervention Type: DRUG

Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

Interventions

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)

Intervention Type: DRUG

Intravenous paracetamol

Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Géraud Claret, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CH d'Alès

Alès, , France

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2015-002381-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2012/PGC-01

Identifier Type: -

Identifier Source: org_study_id