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

• Sponsor: Maria Pacella (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03756038
• Collaborator: University of Pittsburgh Physicians (Other), The UPMC Mercy Emergency Medicine Fund (Other)
• Enrollment: 1
• Locations: 2
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain	Drug: Placebos; Drug: Lorazepam	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Single Dose Administration of Benzodiazepines to Reduce Distress, Pain Severity, and the Need for Opiates Both During and After Emergency Department Care
• Actual Study Start Date: Jan 25, 2019
• Actual Primary Completion Date: Mar 27, 2019
• Actual Study Completion Date: Mar 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.; Other Names: Ativan
Placebo Comparator: Drug: Oral Placebo	Drug: Placebos; In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients

Outcome Measures

Primary Outcome Measures

1. Pain Severity in the Emergency Department: Numeric Rating Scale [The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration]

   Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)

Secondary Outcome Measures

1. Negative Affect in the Emergency Department [The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania	United States	15213
2	UPMC Mercy Hospital	Pittsburgh	Pennsylvania	United States	15219

Sponsors and Collaborators

• Maria Pacella
• University of Pittsburgh Physicians
• The UPMC Mercy Emergency Medicine Fund

Investigators

• Principal Investigator: Maria L Pacella, PhD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 18, 2019

More Information

Publications

None provided.

• Responsible Party: Maria Pacella, Research Assistant Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03756038
• Other Study ID Numbers: PRO18090064
• First Posted: Nov 28, 2018
• Last Update Posted: Mar 9, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Emergencies; Acute Pain; Lorazepam

Study Results

Participant Flow

Arm/Group Title	Drug: Oral Lorazepam (1mg)	Drug: Oral Placebo
Arm/Group 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. 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.	Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
Period Title: Overall Study
STARTED	1	0
COMPLETED	1	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Drug: Oral Lorazepam (1mg)	Drug: Oral Placebo	Total
Arm/Group 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. 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.	Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients	Total of all reporting groups
Overall Participants	1	0	1
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	48	48
Sex: Female, Male (Count of Participants)
Female	1 100%	0 NaN	1 100%
Male	0 0%	0 NaN	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 NaN	0 0%
Not Hispanic or Latino	1 100%	0 NaN	1 100%
Unknown or Not Reported	0 0%	0 NaN	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 NaN	0 0%
Asian	0 0%	0 NaN	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 NaN	0 0%
Black or African American	0 0%	0 NaN	0 0%
White	0 0%	0 NaN	0 0%
More than one race	1 100%	0 NaN	1 100%
Unknown or Not Reported	0 0%	0 NaN	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility

Arm/Group Title	Drug: Oral Lorazepam (1mg)	Drug: Oral Placebo
Arm/Group 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. 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.	Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
Measure Participants	1	0
Number [units on a scale]	6

2. Secondary Outcome

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.

Outcome Measure Data

Analysis Population Description

No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility

Arm/Group Title	Drug: Oral Lorazepam (1mg)	Drug: Oral Placebo
Arm/Group 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. 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.	Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
Measure Participants	1	0
Number [units on a scale]	10

Adverse Events

Time Frame	2-weeks of study duration
Adverse Event Reporting Description	There are 0 participants at risk in the placebo arm because no participants were enrolled to that arm.
Arm/Group Title	Drug: Oral Lorazepam (1mg)		Drug: Oral Placebo
Arm/Group 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. 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.		Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
All Cause Mortality
	Drug: Oral Lorazepam (1mg)		Drug: Oral Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	Drug: Oral Lorazepam (1mg)		Drug: Oral Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Drug: Oral Lorazepam (1mg)		Drug: Oral Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.