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

Primary Purpose

Renal Colic, Acute Renal Colic

Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Intravenous ketoprofen
Intravenous paracetamol
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CH d'Alès
  • CHU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ketaprofen

Paracetamol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in vns for pain
Verbal numeric scale ranging from 0 to 10.0.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2012
Last Updated
August 11, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01685658
Brief Title
Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations
Acronym
PIVKIV
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
same study already published
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic, Acute Renal Colic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketaprofen
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen
Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Patients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol
Intervention Type
Drug
Intervention Name(s)
Intravenous ketoprofen
Intervention Description
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
Intervention Name(s)
Intravenous paracetamol
Intervention Description
Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)
Primary Outcome Measure Information:
Title
Change in vns for pain
Description
Verbal numeric scale ranging from 0 to 10.0.
Time Frame
baseline to 30 minutes
Secondary Outcome Measure Information:
Title
Change in vns for pain
Description
Verbal numeric scale ranging from 0 to 10.0.
Time Frame
baseline to 90 minutes
Title
Quantity of (posology) tramadol administered
Time Frame
baseline (minute 0)
Title
Quantity of (posology) tramadol administered
Time Frame
30 minutes
Title
Quantity of (posology) tramadol administered
Time Frame
90 minutes
Title
Quantity of (posology) tramadol administered
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Quantity of (posology) phloroglucinol administered
Time Frame
baseline (minute 0)
Title
Quantity of (posology) phloroglucinol administered
Time Frame
30 minutes
Title
Quantity of (posology) phloroglucinol administered
Time Frame
90 minutes
Title
Quantity of (posology) phloroglucinol administered
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Was morphine administered? yes/no
Time Frame
baseline (minute 0)
Title
Quantity of (posology) morphine administered
Time Frame
30 minutes
Title
Quantity of (posology) morphine administered
Time Frame
90 minutes
Title
Quantity of (posology) morphine administered
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Quantity of (posology) Nefopam administered
Time Frame
baseline (minute 0)
Title
Quantity of (posology) Nefopam administered
Time Frame
30 minutes
Title
Quantity of (posology) Nefopam administered
Time Frame
90 minutes
Title
Quantity of (posology) Nefopam administered
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Quantity of (posology) Alfuzosine administered
Time Frame
baseline (minute 0)
Title
Quantity of (posology) Alfuzosine administered
Time Frame
30 minutes
Title
Quantity of (posology) Alfuzosine administered
Time Frame
90 minutes
Title
Quantity of (posology) Alfuzosine administered
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Presence/absence of complications
Description
cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
Time Frame
baseline (minute 0)
Title
Presence/absence of complications
Description
cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
Time Frame
30 minutes
Title
Presence/absence of complications
Description
cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
Time Frame
90 minutes
Title
Presence/absence of complications
Description
cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine
Time Frame
week 1
Title
Was the patient hospitalized? yes/no
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Was the patient hospitalized? yes/no
Time Frame
week 1
Title
VNS for patient satisfaction concerning care
Time Frame
week 1
Title
Evolution towards a complicated renal colic
Description
Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death
Time Frame
discharge from emergency ward (estimated max of 24 hours)
Title
Evolution towards a complicated renal colic
Description
Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death
Time Frame
week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Géraud Claret, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Alès
City
Alès
ZIP/Postal Code
30103
Country
France
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 9
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

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