Renal ColicPhase 4PIVKIVNCT01685658
Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations
A Phase 4 study testing Intravenous ketoprofen and Intravenous paracetamol in people with Renal Colic and Acute Renal Colic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic, Acute Renal Colic
- What is being tested?
- Intravenous ketoprofen and Intravenous paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2016to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CH d'Alès
Alès, 30103
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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
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.
Read the 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
- Being tested
- Intravenous ketoprofen, Intravenous paracetamol
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ketoprofenDrug
Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)
Intravenous paracetamolDrug
Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)
| Study group | Role | What they receive |
|---|---|---|
| Ketaprofen | Active comparator | Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic.
Intervention: intravenous ketaprofen Receives: Drug: Intravenous ketoprofen |
| Paracetamol | Experimental | Patients randomized to this arm will receive intravenous paracetamol when treating renal colic.
Intervention: intravenous paracetamol Receives: Drug: Intravenous paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vns for pain
Verbal numeric scale ranging from 0 to 10.0.
Measured: baseline to 30 minutes
Secondary outcomes (30)
Change in vns for pain
Verbal numeric scale ranging from 0 to 10.0.
Measured: baseline to 90 minutes
Quantity of (posology) tramadol administered
Measured: baseline (minute 0)
Quantity of (posology) tramadol administered
Measured: 30 minutes
Quantity of (posology) tramadol administered
Measured: 90 minutes
Quantity of (posology) tramadol administered
Measured: discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) phloroglucinol administered
Measured: baseline (minute 0)
Quantity of (posology) phloroglucinol administered
Measured: 30 minutes
Quantity of (posology) phloroglucinol administered
Measured: 90 minutes
Quantity of (posology) phloroglucinol administered
Measured: discharge from emergency ward (estimated max of 24 hours)
Was morphine administered? yes/no
Measured: baseline (minute 0)
Quantity of (posology) morphine administered
Measured: 30 minutes
Quantity of (posology) morphine administered
Measured: 90 minutes
Quantity of (posology) morphine administered
Measured: discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Nefopam administered
Measured: baseline (minute 0)
Quantity of (posology) Nefopam administered
Measured: 30 minutes
Quantity of (posology) Nefopam administered
Measured: 90 minutes
Quantity of (posology) Nefopam administered
Measured: discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Alfuzosine administered
Measured: baseline (minute 0)
Quantity of (posology) Alfuzosine administered
Measured: 30 minutes
Quantity of (posology) Alfuzosine administered
Measured: 90 minutes
Quantity of (posology) Alfuzosine administered
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: week 1
Was the patient hospitalized? yes/no
Measured: discharge from emergency ward (estimated max of 24 hours)
Was the patient hospitalized? yes/no
Measured: week 1
VNS for patient satisfaction concerning care
Measured: 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
Measured: 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
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startSep 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: same study already published
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Géraud Claret, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685658
- Sponsor's protocol ID
- LOCAL/2012/PGC-01
- Other IDs
- 2015-002381-23, 2015
- Acronym
- PIVKIV
- Status last verified
- Aug 2020
- First submitted
- 12 Sep 2012
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01685658
- Acronym / sponsor ID
- PIVKIV / LOCAL/2012/PGC-01
- Conditions
- Renal Colic, Acute Renal Colic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: same study already published
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketaprofen | Active comparator | Drug: Intravenous ketoprofenPatients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen |
| Paracetamol | Experimental | Drug: Intravenous paracetamolPatients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ketoprofenPatients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution) | Drug | Ketaprofen |
| Intravenous paracetamolPatients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml) | Drug | Paracetamol |
Primary outcome
Change in vns for pain
Time frame: baseline to 30 minutes
Verbal numeric scale ranging from 0 to 10.0.
30 secondary outcomes
Change in vns for pain
Time frame: baseline to 90 minutes
Quantity of (posology) tramadol administered
Time frame: baseline (minute 0)
Quantity of (posology) tramadol administered
Time frame: 30 minutes
Quantity of (posology) tramadol administered
Time frame: 90 minutes
Quantity of (posology) tramadol administered
Time frame: discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) phloroglucinol administered
Time frame: baseline (minute 0)
Quantity of (posology) phloroglucinol administered
Time frame: 30 minutes
Quantity of (posology) phloroglucinol administered
Time frame: 90 minutes
Quantity of (posology) phloroglucinol administered
Time frame: discharge from emergency ward (estimated max of 24 hours)
Was morphine administered? yes/no
Time frame: baseline (minute 0)
Quantity of (posology) morphine administered
Time frame: 30 minutes
Quantity of (posology) morphine administered
Time frame: 90 minutes
Quantity of (posology) morphine administered
Time frame: discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Nefopam administered
Time frame: baseline (minute 0)
Quantity of (posology) Nefopam administered
Time frame: 30 minutes
Quantity of (posology) Nefopam administered
Time frame: 90 minutes
Quantity of (posology) Nefopam administered
Time frame: discharge from emergency ward (estimated max of 24 hours)
Quantity of (posology) Alfuzosine administered
Time frame: baseline (minute 0)
Quantity of (posology) Alfuzosine administered
Time frame: 30 minutes
Quantity of (posology) Alfuzosine administered
Time frame: 90 minutes
Quantity of (posology) Alfuzosine administered
Time frame: discharge from emergency ward (estimated max of 24 hours)
Presence/absence of complications
Time frame: baseline (minute 0)
Presence/absence of complications
Time frame: 30 minutes
Presence/absence of complications
Time frame: 90 minutes
Presence/absence of complications
Time frame: week 1
Was the patient hospitalized? yes/no
Time frame: discharge from emergency ward (estimated max of 24 hours)
Was the patient hospitalized? yes/no
Time frame: week 1
VNS for patient satisfaction concerning care
Time frame: week 1
Evolution towards a complicated renal colic
Time frame: discharge from emergency ward (estimated max of 24 hours)
Evolution towards a complicated renal colic
Time frame: week 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Géraud Claret, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous ketoprofen and Intravenous paracetamol in people with Renal Colic and Acute Renal Colic, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vns for pain (time frame: baseline to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.