Clinical trial NCT06072950: Opioid Use and Predicting Factors at the Emergency Department
Official title: Opioid Use and Predicting Factors at the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Pain, Acute
Keywords: Emergency Department
Pain at rest
Opioid use
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 149
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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)

Primary outcomes:
measure: Opioid use
timeFrame: throughout study participation, up to 8 hours
Secondary outcomes:
measure: Oral morphine equivalent
timeFrame: throughout study participation, up to 8 hours
measure: Administered analgesics
timeFrame: throughout study participation, up to 8 hours
measure: Pain acceptability
timeFrame: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
measure: Reason why patients finds pain acceptable
timeFrame: Assessed upon admittance
measure: Patients desire for analgesics
timeFrame: Asked at moment of admittance and at discharge, up to 6 hours after inclusion
measure: Patients openness to VR
timeFrame: Assessed upon admittance
measure: Numaric rating score pain scores at rest
timeFrame: Every 30 minutes until discharge of patient
measure: Numaric rating score anxiety scores
timeFrame: Every 30 minutes until discharge of patient
measure: Satisfaction with pain management
timeFrame: Asked at moment of discharge, up to 6 hours after inclusion
measure: Nurse opinion on patient adequacy of pain reporting
timeFrame: Assessed upon admittance
measure: Duration of ED visit
timeFrame: throughout study participation, up to 8 hours
measure: Analgesics prescriptions
timeFrame: throughout study participation, up to 8 hours
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: