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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Placebos
* Drug: Lorazepam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Oral Lorazepam (1mg)<br>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: Lorazepam<br>* The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.<br>* Other names: Ativan;|
| Placebo Comparator: Drug: Oral Placebo<br> | Drug: Placebos<br>* In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Affect in the Emergency Department | 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. | The 10 items of the Negative Affect Scale are anchored to mood right now at 60 minutes post-study drug administration. |