Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 12:05 AM
NCT ID: NCT01685658
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: NCT01685658
Study Brief:
Protocol Section: NCT01685658