NCT03278652

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

September 5, 2017

Last Update Submit

September 7, 2017

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

  • Number of analgesic drug used in the context of renal colic in emergency rooms by following the recommended and validated service protocol

    Collection of name, dosage, route of administration, time of issue of the drug

    During hospitalisation in emergency rooms

Study Arms (1)

Patient with renal colic

Other: Consumption of drugs for analgesic use

Interventions

Consumption of drugs for analgesic useOTHER

* Regular assessment of pain * Drug data will be collected (name, dosage, route of administration, time of delivery)

Patient with renal colic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with renal colic

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

RECRUITING

MeSH Terms

Conditions

Renal Colic

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandre Tanneau, MD

CONTACT

02.99.28.60.48alexandre.tanneau@chu-rennes.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 11, 2017

Study Start

April 19, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)