Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi - Full Text View

Sponsored by:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00639574

Purpose

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	Intervention	Phase
Ureteral Calculi, Hyperalgic, Not Complicated	Drug: Néfopam	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.

Resource links provided by NLM:

Drug Information available for: Nefopam Nefopam hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Need to use morphine as an analgesic scheme (binary yes/no) [ Time Frame: As analgesic scheme ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	52
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639574

Contacts

Contact: Patrick Lacarin

04.73.75.1195

placarin@chu-clermontferrand.fr

Locations

France
CHU Clermont-Ferrand	Recruiting
Clermont-Ferrand, France, 63003
Contact: Moustafa Farès

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:

Moustafa Fares, Dr

University Hospital, Clermont-Ferrand

More Information

No publications provided

Responsible Party:	CHU Clermont-Ferrand ( Moustafa Farès )
Study ID Numbers:	CHU-0030
Study First Received:	March 14, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00639574 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Calculi
Ketoprofen
Morphine
Urolithiasis
Ureteral Calculi
Ureteral Diseases
Pain

Calculi
Nefopam
Ureterolithiasis
Urologic Diseases
Analgesics, Non-Narcotic
Emergencies
Peripheral Nervous System Agents
Analgesics

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Physiological Effects of Drugs
Ureteral Calculi
Ureteral Diseases
Calculi
Nefopam
Pharmacologic Actions

Ureterolithiasis
Urologic Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 06, 2009