Pain Evaluation and Treatment in the Emergency Department | NCT02980172

Studies
Pain Evaluation and Treatment in the Emergency Department

NCT02980172

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Jul 27, 2017Actual

Enrollment

31,942Actual

Phase

Not provided

Conditions

Pain, Acute
Emergencies

Interventions

Pain evaluation

Countries

Switzerland

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

Jul 2017

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

Nov 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Nov 24, 2016

First Submission Date that Met QC Criteria

Dec 1, 2016

First Posted Date

Dec 2, 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

Jul 26, 2017

Last Update Posted Date

Jul 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olivier T. Rutschmann, Professor, Deputy Chief, University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

All patients admitted in Geneva University Hospitals (GUH) emergency department (ED) are triaged using the Swiss Emergency Triage Scale (SETS), a 4-level symptom-based triage scale. At the end of the triage process the triage nurse has to choose an emergency level and a main presenting complaint among a listing of 98 presenting complaints. The SETS recommends a pain evaluation for 44 out of the SETS 98 presenting complaint.

The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria. The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.

Detailed Description

After this evaluation, a protocol standardize administration of analgesia for patients presenting pain.

The primary objective of the study is to determine whether pain is correctly evaluated when required by the SETS criteria for the 44 presenting complaints.

The secondary objectives are (1) to evaluate whether an appropriate treatment is delivered when pain is present, and (2) to identify predictors of pain evaluation and treatment.

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

31,942Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pain triage complaint		Patients admitted at GUH ED triaged with a main complaint requiring a pain evaluation.	Other: Pain evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain evaluation	Other	Evaluation of pain using a numerical scale (1 to 10)	Pain triage complaint

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with appropriate pain evaluation	Percentage of patients with a documented assessement of pain using a numerical scale (0 to 10)	Within 24 hours after ED admission

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with appropriate pain treatment	Percentage of patients who received an appropriate treatment accordingly to the ED recommendations.	Within 24 hours after ED admission

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult (>= 16y) patients admitted at GUH ED during one year
presenting complaint requiring pain evaluation accordingly to the SETS criteria

Exclusion Criteria:

< 16 y
presenting complaint that does not require a pain evaluation accordingly to the SETS criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients admitted during one year at GUH ED.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier T Rutschmann, MD, MPH	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospitals, ED		Geneva		1211	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059787	Acute Pain
D004630	Emergencies

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided