Status:
TERMINATED
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
Lead Sponsor:
Maria Pacella
Collaborating Sponsors:
University of Pittsburgh Physicians
University of Pittsburgh
Conditions:
Acute Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
In this proposal, the investigators will determine if a single dose of oral lorazepam reduces distress, pain severity, and need for opiate analgesics both in the ED and in the acute recovery period af...
Detailed Description
The investigators will enroll 120 medically stable adult patients who present to two emergency departments with a physical injury (\< 24 hours ago) and a chief complaint of pain. The investigators wi...
Eligibility Criteria
Inclusion
- Adults between the ages of 18-65
- Sustained a physical injury with a pain score ≥ 5 on the numeric rating scale \[NRS\] from 0- 10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable"
- Expected to be in the ED for at least 2 hours, in a private treatment room
- Ownership of a cell phone with text messaging capabilities
- Emergency Department admission assessment confirmed subject is not suicidal.
Exclusion
- Non-English speaking
- Not medically suitable for lorazepam per treating MD (e.g. medical condition where benzodiazepines are contraindicated or may be unsafe)
- Not alert and oriented
- Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
- Seeking treatment due to a mental health or substance use disorder
- History of chronic opioid use
- Prescribed opioid or benzodiazepine use within the past 24 hours
- Alcohol use within the past 12 hours or medical history of alcoholism.
- Clinical indication for open-label benzodiazepine administration in the ED.
- Any use of recreational narcotics throughout lifetime
- Sensitivity or allergy or intolerance to opioids or benzodiazepines
- Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
- Prisoner
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03756038
Start Date
January 25 2019
End Date
March 27 2019
Last Update
March 9 2020
Active Locations (2)
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1
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219