- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Presbyterian Hospital
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Pittsburgh, Pennsylvania, United States, 15219
- UPMC Mercy Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
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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:
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Placebo Comparator: Drug: Oral Placebo
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In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
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The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria L Pacella, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Pain
- Neurologic Manifestations
- Disease Attributes
- Emergencies
- Acute Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Lorazepam
Other Study ID Numbers
- PRO18090064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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