Opioid Use and Predicting Factors at the Emergency Department

NCT06072950 | Completed

• 1 other identifier: 113728
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Increasing opioid misuse is a worldwide problem. About 10% of opioid misusers are primarily exposed to opioids at the Emergency Department (ED). This study was conducted to determine the feasibility for a clinical trial investigating the effect of Virtual Reality therapy on opioid consumption at the ED. Methods: Adult patients were included when primarily seen by the Emergency Physician and presenting with a NRS pain score ≥4. Main objective was to identify the target population and evaluate outcome measures to sustain a trial incorporating the Oral Morphine Equivalent (OME) at the ED as the primary endpoint. Primary outcome was mean OME administered at the ED. Secondary outcomes included NRS pain scores, main symptoms and type of analgesics administered at the ED.

Conditions

Pain; Pain, Acute

Keywords

Emergency Department; Pain at rest; Opioid use

Outcome Measures

Primary Outcomes (1)

• Opioid use

  Opioids use of patients during their stay at Emergency Department (yes/no)

  throughout study participation, up to 8 hours

Secondary Outcomes (12)

• Oral morphine equivalent

  throughout study participation, up to 8 hours

• Administered analgesics

  throughout study participation, up to 8 hours

• Pain acceptability

  Asked at moment of admittance and at discharge, up to 6 hours after inclusion

• Reason why patients finds pain acceptable

  Assessed upon admittance

• Patients desire for analgesics

  Asked at moment of admittance and at discharge, up to 6 hours after inclusion

Study Arms (1)

Patient with NRS pain at rest being 4 or higher

Patient with NRS pain at rest being 4 or higher, primarily treated by emergency physician, internist, or surgeon. All patients receive usual care, no interventions are administered.

Other: Usual care

Interventions

Usual care OTHER

Patients received usual care

Patient with NRS pain at rest being 4 or higher

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We aim to include all patients ≥16 years, who are admitted to the ED of the Radboudumc and primarily seen by an ED physician.

You may qualify if:

• Patient ≥16 years admitted to ED and identified by an Emergency Physician (EP)
• NRS pain score ≥4
• Patient is willing and able to comply with the study protocol

You may not qualify if:

• Patients initially treated by another physician than the EP.
• EMV \< 14
• History of dementia, seizures
• Severe hearing/visual impairment not corrected
• Headwounds or damaged skin with which comfortable and hygienic use is not possible.
• Presentation to ED because of chronic pain (≥3 months) exacerbation
• Chronic opioids use (≥3 months)

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

MeSH Terms

Conditions

Pain; Acute Pain; Emergencies

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 10, 2023
• Study Start: February 13, 2023
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-09

Locations

NL (1)