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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03756038
Recruitment Status : Terminated (It was not feasible to enroll Emergency Department patients into this protocol)
First Posted : November 28, 2018
Results First Posted : February 26, 2020
Last Update Posted : March 9, 2020
Sponsor:
Collaborators:
University of Pittsburgh Physicians
The UPMC Mercy Emergency Medicine Fund
Information provided by (Responsible Party):
Maria Pacella, University of Pittsburgh

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.

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Study Type : Interventional  (Clinical Trial)
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).
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 : January 25, 2019
Actual Primary Completion Date : March 27, 2019
Actual Study Completion Date : March 27, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

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 Name: 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




Primary Outcome Measures :
  1. Pain Severity in the Emergency Department: Numeric Rating Scale [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756038


Locations
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United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Sponsors and Collaborators
Maria Pacella
University of Pittsburgh Physicians
The UPMC Mercy Emergency Medicine Fund
Investigators
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Principal Investigator: Maria L Pacella, PhD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Maria Pacella, University of Pittsburgh:
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Responsible Party: Maria Pacella, Research Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03756038    
Other Study ID Numbers: PRO18090064
First Posted: November 28, 2018    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: March 9, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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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:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action