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

Acute Pain Clinical Trial

Official title:

Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03756038
• Other study ID #: PRO18090064
• Status: Terminated
• Phase: Phase 2
• Start date: January 25, 2019
• Est. completion date: March 27, 2019

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Intervention

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

Locations

Country	Name	City	State
United States	UPMC Mercy Hospital	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Maria Pacella	The UPMC Mercy Emergency Medicine Fund, University of Pittsburgh Physicians

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.