Clinical Trial: Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.

Brief 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.


Detailed Summary:

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.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Need to use morphine as an analgesic scheme (binary yes/no) [ Time Frame: As analgesic scheme ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quantity of morphine consumed after titration (mg and number of bolus) [ Time Frame: After titration and after administration of placebo or néfopam ]
  • Pain (measured by the EVA) after administration of placebo or néfopam [ Time Frame: After titration and after administration of placebo or néfopam ]
  • Simplified verbal Scale of Satisfaction [ Time Frame: After titration and after administration of placebo or néfopam ]


Original Secondary Outcome: -Quantity of morphine consumed after titration (mg and number of bolus) -Pain (measured by the EVA) after administration of placebo or néfopam -Simplified verbal Scale of Satisfaction [ Time Frame: After titration and after administration of placebo or néfopam ]

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: March 14, 2008
Date Started: March 2008
Date Completion:
Last Updated: March 26, 2010
Last Verified: March 2010