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Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
This study is currently recruiting participants.
Study NCT00639574   Information provided by University Hospital, Clermont-Ferrand
First Received: March 14, 2008   Last Updated: September 22, 2009   History of Changes

March 14, 2008
September 22, 2009
March 2008
November 2008   (final data collection date for primary outcome measure)
Need to use morphine as an analgesic scheme (binary yes/no) [ Time Frame: As analgesic scheme ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639574 on ClinicalTrials.gov Archive Site
  • 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 ]
-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 ] [ Designated as safety issue: No ]
 
Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.

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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Ureteral Calculi, Hyperalgic, Not Complicated
Drug: Néfopam
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
52
January 2009
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 to 50 years old.
  • Admitted to the emergency room for typical ureteral calculi with severe pain (VAS > or = 60), and microscopic hematuria in the strip without signs of urinary complications.
  • Preliminary Agreement patient.

Exclusion Criteria:

  • Patient disagree.
  • Pregnant women (sought by the questioning).
  • Fever > 38 ° C.
  • Leucocyturie or nitriturie (dipstick).
  • Contraindication to ketoprofen.
  • Contraindication to néfopam.
  • Contraindication to morphine.
  • Contraindication linked to drug interactions as mentioned in the Summary of Product Characteristics of the Authorization for placing on the market of Acupan ®.
  • Treatment opioid analgesics, nonsteroidal anti-inflammatory or inflammatory or paracetamol in the previous 12 hours.
  • Secondary exclusion to a urinary tract infection or systemic.
Both
18 Years to 50 Years
No
Contact: Patrick Lacarin 04.73.75.1195 placarin@chu-clermontferrand.fr
France
 
NCT00639574
Moustafa Farès, CHU Clermont-Ferrand
CHU-0030
University Hospital, Clermont-Ferrand
 
Principal Investigator: Moustafa Fares, Dr University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP