Trial record 1 of 33 for:    Open Studies | "Colic"
Previous Study | Return to List | Next Study

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01685658
First received: September 12, 2012
Last updated: October 28, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Renal Colic
Acute Renal Colic
Drug: Intravenous ketoprofen
Drug: Intravenous paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Change in vns for pain [ Time Frame: baseline to 30 minutes ] [ Designated as safety issue: Yes ]
    Verbal numeric scale ranging from 0 to 10.0.


Secondary Outcome Measures:
  • Change in vns for pain [ Time Frame: baseline to 90 minutes ] [ Designated as safety issue: Yes ]
    Verbal numeric scale ranging from 0 to 10.0.

  • Quantity of (posology) tramadol administered [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Quantity of (posology) tramadol administered [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) tramadol administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) tramadol administered [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Quantity of (posology) phloroglucinol administered [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Quantity of (posology) phloroglucinol administered [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) phloroglucinol administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) phloroglucinol administered [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Was morphine administered? yes/no [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Quantity of (posology) morphine administered [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) morphine administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) morphine administered [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Quantity of (posology) Nefopam administered [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Quantity of (posology) Nefopam administered [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) Nefopam administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) Nefopam administered [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Quantity of (posology) Alfuzosine administered [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: No ]
  • Quantity of (posology) Alfuzosine administered [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) Alfuzosine administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • Quantity of (posology) Alfuzosine administered [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Presence/absence of complications [ Time Frame: baseline (minute 0) ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: 90 minutes ] [ Designated as safety issue: Yes ]
    cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

  • Presence/absence of complications [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: No ]
  • Was the patient hospitalized? yes/no [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • VNS for patient satisfaction concerning care [ Time Frame: week 1 ] [ Designated as safety issue: No ]
  • Evolution towards a complicated renal colic [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ] [ Designated as safety issue: Yes ]
    Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death

  • Evolution towards a complicated renal colic [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]
    Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death


Estimated Enrollment: 338
Study Start Date: September 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685658

Contacts
Contact: Pierre-Géraud Claret, MD +33.(0)4.66.68.80.83 pierre.geraud.claret@gmail.com
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CH d'Alès Not yet recruiting
Alès, France, 30103
Principal Investigator: Michaël Barrillon, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Not yet recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Pierre-Géraud Clarey, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pierre-Géraud Claret, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01685658     History of Changes
Other Study ID Numbers: LOCAL/2012/PGC-01  2015-002381-23 
Study First Received: September 12, 2012
Last Updated: October 28, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Colic
Renal Colic
Emergencies
Abdominal Pain
Disease Attributes
Pain
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Acetaminophen
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016