Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.|
- Need to use morphine as an analgesic scheme (binary yes/no) [ Time Frame: As analgesic scheme ] [ Designated as safety issue: No ]
- Quantity of morphine consumed after titration (mg and number of bolus) [ Time Frame: After titration and after administration of placebo or néfopam ] [ Designated as safety issue: No ]
- Pain (measured by the EVA) after administration of placebo or néfopam [ Time Frame: After titration and after administration of placebo or néfopam ] [ Designated as safety issue: No ]
- Simplified verbal Scale of Satisfaction [ Time Frame: After titration and after administration of placebo or néfopam ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
- a group N : néfopam
- a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes.
There are two groups :
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639574
|Clermont-Ferrand, France, 63003|
|Principal Investigator:||Moustafa Fares, Dr||University Hospital, Clermont-Ferrand|