NCT03756038

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Maria Pacella · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-25
• Primary completion: 2019-03-27
• Completion: 2019-03-27
• First posted: 2018-11-28
• Last updated: 2020-03-09
• Results posted: 2020-02-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study