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Clinical Trial Summary

The administration of néfopam after initial treatment by kétoproféne, could obtain, in patients remaining pain and classically need morphine, analgesia at least the same as morphine alone. The use of néfopam second line after ketoprofen could reducing (or even eliminating) the need for morphine (and its side effects), allowing a reduction in the length of stay of patients in the emergency unit.

The main objective is to show that the addition of a néfopam initial treatment with the kétoproféne, reduces, in patients with ureteral calculi, the percentage of patients requiring the use of a treatment by morphine.

The secondary objective is to reduce the side effects caused by the morphine, shorten the time to install the appropriate level of analgesia while reducing the risk of failure of the titration morphine, reduce the time spent on titration of morphine and reduce the length of stay patient intake in emergency unit.


Clinical Trial Description

The study is prospective, parallel, double-blind, randomized, placebo-controlled analysis with intent to treat. There are 2 groups:

- A group N: néfopam

- A group P: placebo And all the patient receive, before randomization, 100 mg of ketoprofen (Profenid ®) on 20 minutes.

The number of subjects is 52. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00639574
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Completed
Phase Phase 4
Start date March 2008
Completion date September 2009