Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

Study Overview
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Brief Summary
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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
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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)

Official Title
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Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial

Conditions
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Renal Colic, Acute Renal Colic

Intervention / Treatment
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* Drug: Intravenous ketoprofen
* Drug: Intravenous paracetamol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketaprofen<br>Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen | Drug: Intravenous ketoprofen<br>* Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)<br>|
| Experimental: Paracetamol<br>Patients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol | Drug: Intravenous paracetamol<br>* Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vns for pain | Verbal numeric scale ranging from 0 to 10.0. | baseline to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vns for pain | Verbal numeric scale ranging from 0 to 10.0. | baseline to 90 minutes | 
| Quantity of (posology) tramadol administered |  | baseline (minute 0) | 
| Quantity of (posology) tramadol administered |  | 30 minutes | 
| Quantity of (posology) tramadol administered |  | 90 minutes | 
| Quantity of (posology) tramadol administered |  | discharge from emergency ward (estimated max of 24 hours) | 
| Quantity of (posology) phloroglucinol administered |  | baseline (minute 0) | 
| Quantity of (posology) phloroglucinol administered |  | 30 minutes | 
| Quantity of (posology) phloroglucinol administered |  | 90 minutes | 
| Quantity of (posology) phloroglucinol administered |  | discharge from emergency ward (estimated max of 24 hours) | 
| Was morphine administered? yes/no |  | baseline (minute 0) | 
| Quantity of (posology) morphine administered |  | 30 minutes | 
| Quantity of (posology) morphine administered |  | 90 minutes | 
| Quantity of (posology) morphine administered |  | discharge from emergency ward (estimated max of 24 hours) | 
| Quantity of (posology) Nefopam administered |  | baseline (minute 0) | 
| Quantity of (posology) Nefopam administered |  | 30 minutes | 
| Quantity of (posology) Nefopam administered |  | 90 minutes | 
| Quantity of (posology) Nefopam administered |  | discharge from emergency ward (estimated max of 24 hours) | 
| Quantity of (posology) Alfuzosine administered |  | baseline (minute 0) | 
| Quantity of (posology) Alfuzosine administered |  | 30 minutes | 
| Quantity of (posology) Alfuzosine administered |  | 90 minutes | 
| Quantity of (posology) Alfuzosine administered |  | 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 | 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 | 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 | 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 | week 1 | 
| Was the patient hospitalized? yes/no |  | discharge from emergency ward (estimated max of 24 hours) | 
| Was the patient hospitalized? yes/no |  | week 1 | 
| VNS for patient satisfaction concerning care |  | 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 | 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 | week 1 |