VRxOPUS-1: Opioid Use and Predicting Factors at the Emergency Department

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT06072950

Collaborator

(none)

149

Enrollment

Location

6.7

Actual Duration (Months)

22.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Pain, Acute	Other: Usual care

Study Design

Study Type:

Observational

Actual Enrollment :

149 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Opioid Use and Predicting Factors at the Emergency Department

Actual Study Start Date :

Feb 13, 2023

Actual Primary Completion Date :

Sep 4, 2023

Actual Study Completion Date :

Sep 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 Patients received usual care

Arm

Intervention/Treatment

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

Patients received usual care

Outcome Measures

Primary Outcome Measures

Opioid use [throughout study participation, up to 8 hours]
Opioids use of patients during their stay at Emergency Department (yes/no)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud university medical center	Nijmegen	Gelderland	Netherlands	6525 GA

Sponsors and Collaborators

Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radboud University Medical Center

ClinicalTrials.gov Identifier:

NCT06072950

Other Study ID Numbers:

113728

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Radboud University Medical Center

Emergency Department

Pain at rest

Opioid use

Additional relevant MeSH terms:

Emergencies

Acute Pain

Study Results

No Results Posted as of Oct 10, 2023