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It was not feasible to enroll Emergency Department patients into this protocol
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| Name | Class |
|---|---|
| University of Pittsburgh Physicians | OTHER |
| University of Pittsburgh | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Oral Lorazepam (1mg) | Experimental | 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: Oral Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebos | Drug | In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria L Pacella, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC Mercy Hospital |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Drug: Oral Placebo | Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to feasibility issues, we had to prematurely halt enrollment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility | Posted | Number | units on a scale | The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration |
|
2-weeks of study duration
There are 0 participants at risk in the placebo arm because no participants were enrolled to that arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Pacella | University of Pittsburgh | 412-647-3183 | pacellam@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2019 | Feb 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
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| Lorazepam | Drug | 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. |
|
|
| The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration. |
| Pittsburgh |
| Pennsylvania |
| 15219 |
| United States |
| BG001 | Drug: Oral Placebo | Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Drug: Oral Placebo | Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients |
|
|
| Secondary | 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. | No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility | Posted | Number | units on a scale | The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration. |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Drug: Oral Placebo | Placebos: In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |