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

August 11, 2020 updated by: Centre Hospitalier Universitaire de Nīmes

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in vns for pain
Time Frame: baseline to 30 minutes
Verbal numeric scale ranging from 0 to 10.0.
baseline to 30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in vns for pain
Time Frame: baseline to 90 minutes
Verbal numeric scale ranging from 0 to 10.0.
baseline to 90 minutes
Quantity of (posology) tramadol administered
Time Frame: baseline (minute 0)
baseline (minute 0)
Quantity of (posology) tramadol administered
Time Frame: 30 minutes
30 minutes
Quantity of (posology) tramadol administered
Time Frame: 90 minutes
90 minutes
Quantity of (posology) tramadol administered
Time Frame: discharge from emergency ward (estimated max of 24 hours)
discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) phloroglucinol administered
Time Frame: baseline (minute 0)
baseline (minute 0)
Quantity of (posology) phloroglucinol administered
Time Frame: 30 minutes
30 minutes
Quantity of (posology) phloroglucinol administered
Time Frame: 90 minutes
90 minutes
Quantity of (posology) phloroglucinol administered
Time Frame: discharge from emergency ward (estimated max of 24 hours)
discharge from emergency ward (estimated max of 24 hours)
Was morphine administered? yes/no
Time Frame: baseline (minute 0)
baseline (minute 0)
Quantity of (posology) morphine administered
Time Frame: 30 minutes
30 minutes
Quantity of (posology) morphine administered
Time Frame: 90 minutes
90 minutes
Quantity of (posology) morphine administered
Time Frame: discharge from emergency ward (estimated max of 24 hours)
discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Nefopam administered
Time Frame: baseline (minute 0)
baseline (minute 0)
Quantity of (posology) Nefopam administered
Time Frame: 30 minutes
30 minutes
Quantity of (posology) Nefopam administered
Time Frame: 90 minutes
90 minutes
Quantity of (posology) Nefopam administered
Time Frame: discharge from emergency ward (estimated max of 24 hours)
discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Alfuzosine administered
Time Frame: baseline (minute 0)
baseline (minute 0)
Quantity of (posology) Alfuzosine administered
Time Frame: 30 minutes
30 minutes
Quantity of (posology) Alfuzosine administered
Time Frame: 90 minutes
90 minutes
Quantity of (posology) Alfuzosine administered
Time Frame: discharge from emergency ward (estimated max of 24 hours)
discharge from emergency ward (estimated max of 24 hours)
Presence/absence of complications
Time Frame: baseline (minute 0)
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
Time Frame: 30 minutes
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
Time Frame: 90 minutes
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
Time Frame: week 1
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
Time Frame: discharge from emergency ward (estimated max of 24 hours)
discharge from emergency ward (estimated max of 24 hours)
Was the patient hospitalized? yes/no
Time Frame: week 1
week 1
VNS for patient satisfaction concerning care
Time Frame: week 1
week 1
Evolution towards a complicated renal colic
Time Frame: discharge from emergency ward (estimated max of 24 hours)
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
Time Frame: week 1
Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death
week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre-Géraud Claret, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2012/PGC-01
  • 2015-002381-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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