Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ureteral Calculi, Hyperalgic, Not Complicated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No