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Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639574
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : March 29, 2010
Information provided by:
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Ureteral Calculi, Hyperalgic, Not Complicated Drug: Néfopam Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : March 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : September 2009

Intervention Details:
  • Drug: Néfopam

    There are two groups :

    • a group N : néfopam
    • a group P : placebo All the patients receive, before randomization, 100 mg of ketoprofen (Profenid) on 20 minutes.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639574

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CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
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Principal Investigator: Moustafa Fares, Dr University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Moustafa Farès, CHU Clermont-Ferrand Identifier: NCT00639574    
Other Study ID Numbers: CHU-0030
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010
Keywords provided by University Hospital, Clermont-Ferrand:
Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency
Additional relevant MeSH terms:
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Ureteral Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urinary Calculi
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs