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

NCT03756038 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-03-09

Study results available
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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

Interventions

DRUG

Placebos

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

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.

Sponsors & Collaborators

  • University of Pittsburgh Physicians

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Maria Pacella

    lead OTHER

Principal Investigators

  • Maria L Pacella, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2019-03-27
Completion
2019-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756038 on ClinicalTrials.gov