Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

NCT00639574 | Completed Phase 4

• 1 other identifier: CHU-0030
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Calculi, Hyperalgic, Not Complicated

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Need to use morphine as an analgesic scheme (binary yes/no)

  As analgesic scheme

Secondary Outcomes (3)

• Quantity of morphine consumed after titration (mg and number of bolus)

  After titration and after administration of placebo or néfopam

• Pain (measured by the EVA) after administration of placebo or néfopam

  After titration and after administration of placebo or néfopam

• Simplified verbal Scale of Satisfaction

  After titration and after administration of placebo or néfopam

Interventions

Néfopam DRUG

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• Moustafa F, Liotier J, Mathevon T, Pic D, Perrier C, Schmidt J. Usefulness of nefopam in treating pain of severe uncomplicated renal colics in adults admitted to emergency units: a randomised double-blind controlled trial. The 'INCoNU' study. Emerg Med J. 2013 Feb;30(2):143-8. doi: 10.1136/emermed-2011-200753. Epub 2012 Mar 16.

  PMID: 22427403 DERIVED

MeSH Terms

Conditions

Ureteral Calculi; Pain; Emergencies

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Moustafa Fares, Dr

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: September 1, 2009
• Last Updated: March 29, 2010

Record last verified: 2010-03

Locations

FR (1)