Status:
COMPLETED
Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Ureteral Calculi, Hyperalgic, Not Complicated
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
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 ...
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 recei...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00639574
Start Date
March 1 2008
End Date
September 1 2009
Last Update
March 29 2010
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003