ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Analgesic Drugs in Renal Colic in Emergency Room (NEPHROPAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03278652
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms

Condition or disease Intervention/treatment
Renal Colic Other: Consumption of drugs for analgesic use

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of Analgesic Drugs in Renal Colic in Emergency Room
Actual Study Start Date : April 19, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Group/Cohort Intervention/treatment
Patient with renal colic Other: Consumption of drugs for analgesic use
  • Regular assessment of pain
  • Drug data will be collected (name, dosage, route of administration, time of delivery)




Primary Outcome Measures :
  1. Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol [ Time Frame: During hospitalisation in emergency rooms ]
    Collection of name, dosage, route of administration, time of issue of the drug



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with renal colic
Criteria

Inclusion Criteria:

  • Patients older than 18 years old
  • Suspicion of renal colic (pain in a lumbar pit radiating to the external genital organs, rapidly progressive onset, non-febrile)

Exclusion Criteria:

  • Shock
  • Glasgow score less than 15
  • Oxygen saturation less than 93% in ambient air
  • Signs of intracranial hypertension (headache associated with vomiting)
  • Suspicion of pneumothorax
  • History of emphysema or chronic obstructive pulmonary disease
  • Diving accident or suspicion of gas embolism
  • Trauma of the face of interest in the area of application of the mask
  • Abdominal gas distension
  • Contraindication in Nonsteroidal anti-inflammatory drugs
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278652


Contacts
Contact: Alexandre Tanneau, MD 02.99.28.60.48 alexandre.tanneau@chu-rennes.fr

Locations
France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Alexandre Tanneau, MD    02.99.28.60.48    alexandre.tanneau@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03278652     History of Changes
Other Study ID Numbers: 35RC16_3033_NEPHROPAIN
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emergencies
Colic
Renal Colic
Disease Attributes
Pathologic Processes
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs