Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care

Phase 2

Terminated

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 after discharge. The investigators will compare the lorazepam arm to a placebo arm.

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Drug: Oral Lorazepam (1mg)	Lorazepam	Lorazepam (Ativan) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
Drug: Oral Placebo	Placebos	-

Primary Outcome Measures

Name	Time	Method
Pain Severity in the Emergency Department: Numeric Rating Scale	The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration	Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Negative Affect in the Emergency Department	The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.	Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.

Locations (2): UPMC Presbyterian Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
UPMC Mercy Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States