Comparative Study on Acute Pain Evaluation Between Spanis... | NCT02973568

Studies
Comparative Study on Acute Pain Evaluation Between Spanish and French Hospital Emergency Unit

NCT02973568

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Sep 8, 2017Actual

Enrollment

641Actual

Phase

Not provided

Conditions

Pain
EMERGENCY MEDICINE

Interventions

Observational Study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Jul 15, 2017Actual

First Submitted Date

Nov 14, 2016

First Submission Date that Met QC Criteria

Nov 22, 2016

First Posted Date

Nov 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2017

Last Update Posted Date

Sep 8, 2017Actual

Name	Class
Hospital Universitario de Canarias	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Today, pain is a difficult affordable subject in Spain. There are however 187 units of pain care with a consultations rate in emergency center of more than 60%.For example OXYCODONE(opioid analgesic)is widely used while it's under used in Spain.

In the same way MEOPA(Kalinox) is a new approach of pain care daily used as well in France (for example in dislocated shoulder pain, or ulceration care...etc) There are lots of studies relative to chronic pain but not too much about acute pain in Spain.That's why we want to focus our study on evaluation of acute pain treatment and efficacy in french and spanish hospital

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

641Actual

Name	Type	Description	Arm Group Labels	Other Names
Observational Study	Other

Measure	Description	Time Frame
pain VAS (visual analogic scale)		1 hour

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient admitted in emergency center for acute pain.
Patient who accept to participate.

Exclusion Criteria:

Refusal of patient to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Evety patient admitted in emergency center during 1 month for acute pain and who need treatment for pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonay PERERA GIL, PhD student	Groupe Hospitalier Paris Saint-Joseph (FRANCE)	Study Director
Olivier GANANSIA, MD	Fondation Hôpital Saint-Joseph	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided