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Completed

NCT Number: NCT00639574

Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

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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Key information

Conditions

Ureteral Calculi, Hyperalgic, Not Complicated Calculi Disease Attributes Emergencies Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Ureteral Calculi Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: As analgesic scheme

Secondary outcomes

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

    Time frame: After titration and after administration of placebo or néfopam

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

    Time frame: After titration and after administration of placebo or néfopam

  3. Simplified verbal Scale of Satisfaction

    Time frame: After titration and after administration of placebo or néfopam

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Mar 20, 2008
Registry last updated
Mar 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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