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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01685658
Study type Interventional
Source Centre Hospitalier Universitaire de Nimes
Contact
Status Withdrawn
Phase Phase 4
Start date September 2016
Completion date March 2018

See also
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