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

Primary Purpose

Acute Pain

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebos
Lorazepam
Sponsored by
Maria Pacella
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Presbyterian Hospital
  • UPMC Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: Oral Lorazepam (1mg)

Drug: Oral Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
November 26, 2018
Last Updated
February 26, 2020
Sponsor
Maria Pacella
Collaborators
University of Pittsburgh Physicians, The UPMC Mercy Emergency Medicine Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03756038
Brief Title
Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
Official Title
Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
It was not feasible to enroll Emergency Department patients into this protocol
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Pacella
Collaborators
University of Pittsburgh Physicians, The UPMC Mercy Emergency Medicine Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: Oral Lorazepam (1mg)
Arm Type
Experimental
Arm Description
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.
Arm Title
Drug: Oral Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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
Intervention Name(s)
Lorazepam
Other Intervention Name(s)
Ativan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Severity in the Emergency Department: Numeric Rating Scale
Description
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
Time Frame
The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
Secondary Outcome Measure Information:
Title
Negative Affect in the Emergency Department
Description
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.
Time Frame
The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria L Pacella, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
here is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.

Learn more about this trial

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

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