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

NCT03756038 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO18090064
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Drug: Oral Lorazepam (1mg)

EXPERIMENTAL

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

Drug: Oral Placebo

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Placebos DRUG

In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients

Drug: Oral Placebo

Lorazepam DRUG

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.

Also known as: Ativan

Drug: Oral Lorazepam (1mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Pacella: lead
• University of Pittsburgh Physicians: collaborator
• University of Pittsburgh: collaborator

Study Sites (2)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Maria Pacella
• Organization: University of Pittsburgh

pacellam@upmc.edu

412-647-3183

Study Officials

• Maria L Pacella, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: January 25, 2019
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: March 9, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-02

Locations

US (2)