Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
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|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
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Placebos Drug: Lorazepam||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|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)|
|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|
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.
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||
In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
- 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)
- 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.
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
|United States, Pennsylvania|
|UPMC Presbyterian Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|UPMC Mercy Hospital|
|Pittsburgh, Pennsylvania, United States, 15219|
|Principal Investigator:||Maria L Pacella, PhD||University of Pittsburgh|