Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

Renal Colic Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01685658
• Other study ID #: LOCAL/2012/PGC-01
• Secondary ID: 2015-002381-23
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Renal Colic
• Colic
• Emergencies
• Renal Colic

Intervention

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)
• Intravenous paracetamol
Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)

Locations

Country	Name	City	State
France	CH d'Alès	Alès
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vns for pain	Verbal numeric scale ranging from 0 to 10.0.	baseline to 30 minutes
Secondary	Change in vns for pain	Verbal numeric scale ranging from 0 to 10.0.	baseline to 90 minutes
Secondary	Quantity of (posology) tramadol administered		baseline (minute 0)
Secondary	Quantity of (posology) tramadol administered		30 minutes
Secondary	Quantity of (posology) tramadol administered		90 minutes
Secondary	Quantity of (posology) tramadol administered		discharge from emergency ward (estimated max of 24 hours)
Secondary	Quantity of (posology) phloroglucinol administered		baseline (minute 0)
Secondary	Quantity of (posology) phloroglucinol administered		30 minutes
Secondary	Quantity of (posology) phloroglucinol administered		90 minutes
Secondary	Quantity of (posology) phloroglucinol administered		discharge from emergency ward (estimated max of 24 hours)
Secondary	Was morphine administered? yes/no		baseline (minute 0)
Secondary	Quantity of (posology) morphine administered		30 minutes
Secondary	Quantity of (posology) morphine administered		90 minutes
Secondary	Quantity of (posology) morphine administered		discharge from emergency ward (estimated max of 24 hours)
Secondary	Quantity of (posology) Nefopam administered		baseline (minute 0)
Secondary	Quantity of (posology) Nefopam administered		30 minutes
Secondary	Quantity of (posology) Nefopam administered		90 minutes
Secondary	Quantity of (posology) Nefopam administered		discharge from emergency ward (estimated max of 24 hours)
Secondary	Quantity of (posology) Alfuzosine administered		baseline (minute 0)
Secondary	Quantity of (posology) Alfuzosine administered		30 minutes
Secondary	Quantity of (posology) Alfuzosine administered		90 minutes
Secondary	Quantity of (posology) Alfuzosine administered		discharge from emergency ward (estimated max of 24 hours)
Secondary	Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	baseline (minute 0)
Secondary	Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	30 minutes
Secondary	Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	90 minutes
Secondary	Presence/absence of complications	cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine	week 1
Secondary	Was the patient hospitalized? yes/no		discharge from emergency ward (estimated max of 24 hours)
Secondary	Was the patient hospitalized? yes/no		week 1
Secondary	VNS for patient satisfaction concerning care		week 1
Secondary	Evolution towards a complicated renal colic	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)
Secondary	Evolution towards a complicated renal colic	Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death	week 1