Opioid Use and Predicting Factors at the Emergency Department

Pain Clinical Trial

— VRxOPUS-1  

Official title:

Opioid Use and Predicting Factors at the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06072950
• Other study ID #: 113728
• Status: Completed
• Start date: February 13, 2023
• Est. completion date: September 4, 2023

Study information

• Verified date: September 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: September 4, 2023
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Pain
• Pain, Acute

Intervention

Other:
• Usual care
Patients received usual care

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use	Opioids use of patients during their stay at Emergency Department (yes/no)	throughout study participation, up to 8 hours
Secondary	Oral morphine equivalent	Doses of opioids received by a patient during their stay at the ED converted to Oral morphine equivalent (OME)	throughout study participation, up to 8 hours
Secondary	Administered analgesics	Type and dose of all administered analgesics at Emergency Department.	throughout study participation, up to 8 hours
Secondary	Pain acceptability	Patient opinion on acceptability of their pain at rest upon admittance and discharge	Asked at moment of admittance and at discharge, up to 6 hours after inclusion
Secondary	Reason why patients finds pain acceptable	Open question	Assessed upon admittance
Secondary	Patients desire for analgesics	yes/no question whether patient desires analgesics	Asked at moment of admittance and at discharge, up to 6 hours after inclusion
Secondary	Patients openness to VR	yes/no question to explore patients willingeness to use VR in their situation	Assessed upon admittance
Secondary	Numaric rating score pain scores at rest	Including whether this is pre/post analgesics	Every 30 minutes until discharge of patient
Secondary	Numaric rating score anxiety scores	NRS anxiety scores	Every 30 minutes until discharge of patient
Secondary	Satisfaction with pain management	On a numaric rating scale	Asked at moment of discharge, up to 6 hours after inclusion
Secondary	Nurse opinion on patient adequacy of pain reporting	Categorical question: understating - adequate - exaggerating	Assessed upon admittance
Secondary	Duration of ED visit	Duration of ED visit	throughout study participation, up to 8 hours
Secondary	Analgesics prescriptions	When patient is discharged home prescribed analgesics are registered.	throughout study participation, up to 8 hours