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

Maria Pacella

Status and phase: Terminated; Phase 2

Conditions: Acute Pain

Treatments: Drug: Placebos; Drug: Lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT03756038

PRO18090064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Drug: Oral Lorazepam (1mg)

Experimental group

Description:

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.

Treatment:

Drug: Lorazepam

Drug: Oral Placebo

Placebo Comparator group

Treatment:

Drug: Placebos