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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
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.
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CH d'Alès
Alès, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France
Start Date
September 1, 2016
Primary Completion Date
March 1, 2018
Completion Date
March 1, 2018
Last Updated
August 12, 2020
Intravenous ketoprofen
DRUG
Intravenous paracetamol
DRUG
Lead Sponsor
Centre Hospitalier Universitaire de Nīmes
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06233643