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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Colic; Acute Renal Colic
• Intervention / Treatment: Drug: Intravenous ketoprofen; Drug: Intravenous paracetamol

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Alès, France, 30103
    • CH d'Alès
  • Nîmes Cedex 9, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketaprofen; Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen	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)
Experimental: Paracetamol; Patients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol	Drug: Intravenous paracetamol; Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vns for pain	Verbal numeric scale ranging from 0 to 10.0.	baseline to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vns for pain	Verbal numeric scale ranging from 0 to 10.0.	baseline to 90 minutes
Quantity of (posology) tramadol administered		baseline (minute 0)
Quantity of (posology) tramadol administered		30 minutes
Quantity of (posology) tramadol administered		90 minutes
Quantity of (posology) tramadol administered		discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) phloroglucinol administered		baseline (minute 0)
Quantity of (posology) phloroglucinol administered		30 minutes
Quantity of (posology) phloroglucinol administered		90 minutes
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		30 minutes
Quantity of (posology) morphine administered		90 minutes
Quantity of (posology) morphine administered		discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Nefopam administered		baseline (minute 0)
Quantity of (posology) Nefopam administered		30 minutes
Quantity of (posology) Nefopam administered		90 minutes
Quantity of (posology) Nefopam administered		discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Alfuzosine administered		baseline (minute 0)
Quantity of (posology) Alfuzosine administered		30 minutes
Quantity of (posology) Alfuzosine administered		90 minutes
Quantity of (posology) Alfuzosine administered		discharge from emergency ward (estimated max of 24 hours)
Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	baseline (minute 0)
Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	30 minutes
Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	90 minutes
Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	week 1
Was the patient hospitalized? yes/no		discharge from emergency ward (estimated max of 24 hours)
Was the patient hospitalized? yes/no		week 1
VNS for patient satisfaction concerning care		week 1
Evolution towards a complicated renal colic	Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death	discharge from emergency ward (estimated max of 24 hours)
Evolution towards a complicated renal colic	Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death	week 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pierre-Géraud Claret, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Infant, Newborn, Diseases; Renal Colic; Emergencies; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ketoprofen
• Other Study ID Numbers: LOCAL/2012/PGC-01; 2015-002381-23 (EudraCT Number)