Acute Pain
Conditions
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.
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.
Interventions
DRUGPlacebos
In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
DRUGLorazepam
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.
Sponsors
University of Pittsburgh Physicians
University of Pittsburgh
Maria Pacella
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subjects will be randomly assigned to either the experimental condition (lorazepam) or the control condition (placebo).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity in the Emergency Department: Numeric Rating Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Negative Affect in the Emergency Department | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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 |
| Total | 1 |
Baseline characteristics
| Characteristic | Drug: Oral Lorazepam (1mg) | Total | Drug: Oral Placebo |
|---|---|---|---|
| Age, Continuous | 48 years | 48 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
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)
Time frame: The item is anchored to pain intensity right now at 60 minutes post-study drug administration
Population: No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug: Oral Lorazepam (1mg) | Pain Severity in the Emergency Department: Numeric Rating Scale | 6 units on a scale |
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.
Time frame: The 10 items of the Negative Affect Scale are anchored to mood right now at 60 minutes post-study drug administration.
Population: No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug: Oral Lorazepam (1mg) | Negative Affect in the Emergency Department | 10 units on a scale |