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Completed

NCT Number: NCT06072950

Opioid Use and Predicting Factors at the Emergency Department

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.

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Key information

Conditions

Pain Acute Pain Disease Attributes Emergencies Neurologic Manifestations Pain, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Usual Care

Other

Patients received usual care

Primary outcomes

  1. Opioid use

    Time frame: throughout study participation, up to 8 hours

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

Secondary outcomes

  1. Oral morphine equivalent

    Time frame: throughout study participation, up to 8 hours

    Doses of opioids received by a patient during their stay at the ED converted to Oral morphine equivalent (OME)

  2. Administered analgesics

    Time frame: throughout study participation, up to 8 hours

    Type and dose of all administered analgesics at Emergency Department.

  3. Pain acceptability

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

    Patient opinion on acceptability of their pain at rest upon admittance and discharge

  4. Reason why patients finds pain acceptable

    Time frame: Assessed upon admittance

    Open question

  5. Patients desire for analgesics

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

    yes/no question whether patient desires analgesics

  6. Patients openness to VR

    Time frame: Assessed upon admittance

    yes/no question to explore patients willingeness to use VR in their situation

  7. Numaric rating score pain scores at rest

    Time frame: Every 30 minutes until discharge of patient

    Including whether this is pre/post analgesics

  8. Numaric rating score anxiety scores

    Time frame: Every 30 minutes until discharge of patient

    NRS anxiety scores

  9. Satisfaction with pain management

    Time frame: Asked at moment of discharge, up to 6 hours after inclusion

    On a numaric rating scale

  10. Nurse opinion on patient adequacy of pain reporting

    Time frame: Assessed upon admittance

    Categorical question: understating - adequate - exaggerating

  11. Duration of ED visit

    Time frame: throughout study participation, up to 8 hours

    Duration of ED visit

  12. Analgesics prescriptions

    Time frame: throughout study participation, up to 8 hours

    When patient is discharged home prescribed analgesics are registered.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: VRxOPUS-1

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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