A Phase 2 interventional study of Placebos and Lorazepam in Acute Pain, sponsored by Maria Pacella. Terminated at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-09.
Sponsored by Maria Pacella · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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
Drug: Placebos
In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
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.
Also known as: Ativan
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)
Time frame: The item is anchored to pain intensity "right now" at 60 minutes post-study drug administration
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.
Time frame: The 10 items of the Negative Affect Scale are anchored to mood "right now" at 60 minutes post-study drug administration.
| Milestone | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)
| units on a scale | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo |
|---|---|---|
| Pain Severity in the Emergency Department: Numeric Rating Scale | 6 | — |
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.
| units on a scale | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo |
|---|---|---|
| Negative Affect in the Emergency Department | 10 | — |
Collected over 2-weeks of study duration. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Drug: Oral Lorazepam (1mg) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Drug: Oral Placebo | — | — | — |
Due to feasibility issues, we had to prematurely halt enrollment.
| Age, Continuous(years) | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo | Total |
|---|---|---|---|
| Mean | 48 (48 to 48) | — | 48 (48 to 48) |
| Sex: Female, Male(Participants) | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Drug: Oral Lorazepam (1mg) | Drug: Oral Placebo | Total |
|---|---|---|---|
| United States | 1 | — | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — 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.
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Maria Pacella