Clinical Trial: Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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)

Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: Change in vns for pain [ Time Frame: baseline to 30 minutes ]

Original Primary Outcome: Change in visual analog scale for pain [ Time Frame: baseline to 30 minutes ]

Current Secondary Outcome:

• Change in vns for pain [ Time Frame: baseline to 90 minutes ]
  Verbal numeric scale ranging from 0 to 10.0.
• 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) ]
  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 ]
  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 ]
  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 ]
  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) ]
• 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) ]
  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 ]
  Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death

Original Secondary Outcome:

• Change in visual analog scale for pain [ Time Frame: baseline to 90 minutes ]
  Visual analog scale ranging from 0 to 10.0.
• Was tramadol administered? yes/no [ Time Frame: baseline (minute 0) ]
• Was tramadol administered? yes/no [ Time Frame: 30 minutes ]
• Was tramadol administered? yes/no [ Time Frame: 90 minutes ]
• Was tramadol administered? yes/no [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ]
• Was phloroglucinol administered? yes/no [ Time Frame: baseline (minute 0) ]
• Was phloroglucinol administered? yes/no [ Time Frame: 30 minutes ]
• Was phloroglucinol administered? yes/no [ Time Frame: 90 minutes ]
• Was phloroglucinol administered? yes/no [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ]
• Was morphine administered? yes/no [ Time Frame: baseline (minute 0) ]
• Was morphine administered? yes/no [ Time Frame: 30 minutes ]
• Was morphine administered? yes/no [ Time Frame: 90 minutes ]
• Was morphine administered? yes/no [ Time Frame: 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
• 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
• 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
• Presence/absence of complications [ Time Frame: discharge from emergency ward (estimated max of 24 hours) ]
  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 ]
  cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine

Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: September 12, 2012
Date Started: September 2016
Date Completion: March 2018
Last Updated: April 6, 2016
Last Verified: April 2016