Renal Colic, Acute Renal Colic
Conditions
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)
Interventions
Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)
Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vns for pain | baseline to 30 minutes | Verbal numeric scale ranging from 0 to 10.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of (posology) tramadol administered | baseline (minute 0) | — |
| Quantity of (posology) phloroglucinol administered | baseline (minute 0) | — |
| Was morphine administered? yes/no | baseline (minute 0) | — |
| Quantity of (posology) morphine administered | 30 minutes | — |
| Quantity of (posology) Nefopam administered | baseline (minute 0) | — |
| Change in vns for pain | baseline to 90 minutes | Verbal numeric scale ranging from 0 to 10.0. |
| Presence/absence of complications | baseline (minute 0) | 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 | discharge from emergency ward (estimated max of 24 hours) | — |
| VNS for patient satisfaction concerning care | week 1 | — |
| Evolution towards a complicated renal colic | 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 |
| Quantity of (posology) Alfuzosine administered | baseline (minute 0) | — |
Countries
France
Outcome results
None listed