Opioid Use and Predicting Factors at the Emergency Department

NCT ID: NCT06072950

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 149 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2023-09-04

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Usual care

Intervention Type: OTHER

Patients received usual care

Interventions

Usual care

Patients received usual care

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboud university medical center

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

113728

Identifier Type: -

Identifier Source: org_study_id