Clinical trial NCT03756038: Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
Official title: Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Physicians
name: University of Pittsburgh
First posted: 2018-11-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Severity in the Emergency Department: Numeric Rating Scale
timeFrame: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
Secondary outcomes:
measure: Negative Affect in the Emergency Department
timeFrame: The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Mercy Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Maria L Pacella, PhD
role: PRINCIPAL_INVESTIGATOR
References: