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Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

Primary Purpose

Ureteral Calculi, Hyperalgic, Not Complicated

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Néfopam
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureteral Calculi, Hyperalgic, Not Complicated focused on measuring Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Clermont-Ferrand

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quantity of morphine consumed after titration (mg and number of bolus)
Pain (measured by the EVA) after administration of placebo or néfopam
Simplified verbal Scale of Satisfaction

Full Information

First Posted
March 14, 2008
Last Updated
March 26, 2010
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00639574
Brief Title
Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi
Official Title
Interest of Néfopam in the Treatment of Pain During the Intense Ureteral Calculi Uncomplicated in Adults in Emergencies Unit.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureteral Calculi, Hyperalgic, Not Complicated
Keywords
Pain, morphine, nefopam, co analgesia, ureteral calculi, emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Néfopam
Intervention Description
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 Outcome Measure Information:
Title
Need to use morphine as an analgesic scheme (binary yes/no)
Time Frame
As analgesic scheme
Secondary Outcome Measure Information:
Title
Quantity of morphine consumed after titration (mg and number of bolus)
Time Frame
After titration and after administration of placebo or néfopam
Title
Pain (measured by the EVA) after administration of placebo or néfopam
Time Frame
After titration and after administration of placebo or néfopam
Title
Simplified verbal Scale of Satisfaction
Time Frame
After titration and after administration of placebo or néfopam

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustafa Fares, Dr
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22427403
Citation
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.
Results Reference
derived

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Nefopam and Morphine Consumption in the Treatment of Ureteral Calculi

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