NCT01685658WithdrawnPhase 4
Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial
Centre Hospitalier Universitaire de Nīmes2 sites in 1 countryStarted: September 2016Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Change in vns for pain
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/
- •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.
Arms & Interventions
Ketaprofen
Active Comparator
Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic.
Intervention: intravenous ketaprofen
Intervention: Intravenous ketoprofen (Drug)
Paracetamol
Experimental
Patients randomized to this arm will receive intravenous paracetamol when treating renal colic.
Intervention: intravenous paracetamol
Intervention: Intravenous paracetamol (Drug)
Outcomes
Primary Outcomes
Change in vns for pain
Time Frame: baseline to 30 minutes
Verbal numeric scale ranging from 0 to 10.0.
Secondary Outcomes
- Change in vns for pain(baseline to 90 minutes)
- Quantity of (posology) tramadol administered(discharge from emergency ward (estimated max of 24 hours))
- 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(discharge from emergency ward (estimated max of 24 hours))
- Quantity of (posology) Nefopam administered(discharge from emergency ward (estimated max of 24 hours))
- Quantity of (posology) Alfuzosine administered(discharge from emergency ward (estimated max of 24 hours))
- Presence/absence of complications(week 1)
- Was the patient hospitalized? yes/no(week 1)
- VNS for patient satisfaction concerning care(week 1)
- Evolution towards a complicated renal colic(week 1)
Investigators
Study Sites (2)
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