Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/27/2019 |
| Start Date: | March 2019 |
| End Date: | December 31, 2019 |
| Contact: | Maria L Pacella, PhD |
| Email: | pacellam@upmc.edu |
| Phone: | 4126473183 |
Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
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 after discharge. The investigators will compare the lorazepam arm to a
placebo arm.
distress, pain severity, and need for opiate analgesics both in the ED and in the acute
recovery period after discharge. The investigators will compare the lorazepam arm to a
placebo arm.
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 will randomly assign subjects using a blocked randomization schedule to
either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department
providers and patients will be blind to treatment allocation.
All participants will complete measures of negative affect and pain scores at baseline, and
and 1 and 2 hours post-study drug administration. The investigators will record any
analgesics administered in the emergency department until discharge. Patients will also
undergo quantitative sensory testing in the Emergency Department at baseline, and after study
drug administration. At 14-days post-discharge, the investigators will measure summary
reports of pain, mood, and analgesic medication used.
emergency departments with a physical injury (< 24 hours ago) and a chief complaint of pain.
The investigators will randomly assign subjects using a blocked randomization schedule to
either: 1) a single dose of oral lorazepam (1mg), or 2) oral placebo. Emergency department
providers and patients will be blind to treatment allocation.
All participants will complete measures of negative affect and pain scores at baseline, and
and 1 and 2 hours post-study drug administration. The investigators will record any
analgesics administered in the emergency department until discharge. Patients will also
undergo quantitative sensory testing in the Emergency Department at baseline, and after study
drug administration. At 14-days post-discharge, the investigators will measure summary
reports of pain, mood, and analgesic medication used.
Inclusion Criteria:
- 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 Criteria:
- 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
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