Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 4

Conditions

Ureteral Calculi, Hyperalgic, Not Complicated

Treatments

Drug: Néfopam

Study type

Interventional

Funder types

Other

Identifiers

NCT00639574

CHU-0030

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.