NCT04625374

Brief Summary

The main objective for investigators is to determine the prevalence of moderate to severe chronic pain in the adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission and defined as greater than or equal to 6/10 by the numerical pain scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
495

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

December 5, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

November 5, 2020

Last Update Submit

May 23, 2022

Conditions

Keywords

prevalence chronic painemergency departmentsevere acute paininitial analgesia

Outcome Measures

Primary Outcomes (1)

  • Determine prevalence of moderate to severe chronic pain in adult population 6 months after consultation in the emergency department for acute pain (less than 7 days old) and severe pain assessed at admission (defined ≥6/10 by the numerical pain scale)

    The main judgment criteria is the presence of chronic pain, related to the pain that motivated the emergency department visit 6 months earlier, moderate to severe defined as pain evolving since the emergency department visit (6 months), experienced at least 2 times per week, and of intensity ≥ 4 on a numerical pain scale during the patient's last painful experience.

    6 month

Secondary Outcomes (10)

  • To compare the prevalence of chronic pain in patients who initially consulted for pain of traumatic or non-traumatic origin.

    6 month

  • Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management in use of analgesic, which molecule when the patient goes to the emergency department ;

    6 month

  • Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management in use of analgesic at which dose when the patient goes to the emergency department ;

    6 month

  • Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management at the performance of a locoregional anaesthesia when the patient goes to the emergency department ;

    6 month

  • Evaluate whether there is an association between the prevalence of chronic pain at 6 months and pain management at the performance of sedation when the patient goes to the emergency department ;

    6 month

  • +5 more secondary outcomes

Eligibility Criteria

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

Patient who have consulted in the emergency department between 4 to 5 months before reading the files to be contacted 6 months after the consultation in the emergency department

You may qualify if:

  • To have consulted in the emergency department between 4 to 5 months before reading the files to be contacted 6 months after the consultation in the emergency department;
  • Initial pain ≥6 on the Numerical Pain Scale ;
  • Acute pain that has been evolving for less than 7 days.
  • No oral opposition of the subject required during the phone call

You may not qualify if:

  • Patient who has undergone surgery in the direct course or within one month of the emergency department visit;
  • Patient with suspected or confirmed coronary chest pain at the time of discharge from the emergency department;
  • Patient with a mental disability;
  • Patient dead;
  • Patient who is deaf or hard of hearing;
  • Patient who does not speak French or does not live in France
  • Patient whose medical history was noted in the file as being impossible due to communication problems;
  • Patient who left the emergency department before the end of medical care;
  • Patient consulting for acutization of chronic pain;
  • Patient during pregnancy;
  • Patient consulting for a recent complication of care (within the month), surgical or other;
  • Patient taking daily analgesic treatments in the last 2 months;
  • Patient known to be dependent on opioids or treated with substitution therapy;
  • Homeless patient;
  • Patient who has been injured in the course of an assault or violence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Pellegrin

Bordeaux, 33000, France

Location

Grenoble Alpes University Hospital

Grenoble, 38000, France

Location

MeSH Terms

Conditions

EmergenciesAcute Pain

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 12, 2020

Study Start

December 5, 2020

Primary Completion

September 1, 2021

Study Completion

March 1, 2022

Last Updated

May 24, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations