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

NCT ID: NCT03756038

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2019-03-27

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lorazepam

Intervention Type: 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.

Drug: Oral Placebo

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

Placebos

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Ativan

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Physicians

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Maria Pacella

OTHER

Sponsor Role: lead

Responsible Party

Maria Pacella

Research Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maria L Pacella, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO18090064

Identifier Type: -

Identifier Source: org_study_id