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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Lorazepam; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Presbyterian Hospital
    • Pittsburgh, Pennsylvania, United States, 15219
      • UPMC Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug: Oral Lorazepam (1mg); 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; 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.; Other Names: Ativan
Placebo Comparator: Drug: Oral Placebo	Drug: Placebos; In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Maria Pacella
• Collaborators: University of Pittsburgh Physicians; The UPMC Mercy Emergency Medicine Fund
• Investigators: Principal Investigator: Maria L Pacella, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Lorazepam
• Other Study ID Numbers: PRO18090064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: here is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes