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

September 7, 2017 updated by: Rennes University Hospital
A prospective non-interventional study on the use of analgesic drugs in renal colic in emergency rooms

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with renal colic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During hospitalisation in emergency rooms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2016

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

September 5, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC16_3033_NEPHROPAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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